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Software as a medical device (SaMD)

Can you combine the software development lifecycle with design controls when you are developing software as a medical device (SaMD)?

Don’t forget to subscribe to our YouTube channel for more medical device quality and regulatory training. There has been a remarkable increase in the number of medical devices developed in the past few years that consist of only software. The medical device industry refers to these products as software as a medical device (SaMD). Along with the increase in the number of SaMDs on the market, there has also been an increase in the number of companies that are developing these SaMDs without any prior medical device industry experience. Medical Device Academy specializes in helping start-up medical device companies, and we see common characteristics shared by these MedTech start-ups. First, they are usually successful in demonstrating proof of concept for their software device within months. Second, the development team is typically virtual (i.e. everyone lives in a different state or even in different countries). Third, the development team does not include anyone with quality or regulatory responsibility. Fourth, the company has not implemented software design controls or started a design history file (DHF). Fifth, the company is not even aware of the existence of IEC 62304 (less expensive than other websites) –the international standard that defines the life cycle requirements for medical device software.

The above situation is quite common, but it is not a serious problem. These Medtech start-ups just need guidance on how to comply with medical device regulations without creating an overly burdensome quality system and excessive documentation. At the same time, these companies need to stay small, agile, and thrifty. Most people believe that the quality system and software documentation process slows down the development process, but the intent is to prevent mistakes and to help you plan the design and development of your SaMD so that the resulting software is safe and performs as you intended (i.e. efficacious). In order to create a quality system and software documentation process that is lean and efficient, there are some common pitfalls you should avoid.

When do you need to implement a quality system for software as a medical device (SaMD)?

When a quality system is required depends upon which market you are launching your product in first. If you are launching your product in Canada, you need a special kind of quality system certificate before you can apply for a Canadian Medical Device License (i.e. MDSAP Certificate for ISO 13485:2016). MDSAP stands for “medical device single audit program,” and there are only 16 organizations that can issue this type of certificate. If you are launching your product in Europe, you will go through your ISO 13485 quality system certification in parallel with obtaining the CE Certification of your SaMD. If you are launching your product in the USA, you do not need your quality system to be complete until after you obtain 510(k) clearance and you are ready to register and list with the FDA. You also do not need ISO certification for the US market. If your SaMD is a Class 1 device in any of these three markets, you may have fewer quality systems and regulatory requirements.

Regardless of which market you are planning to launch your product in, you should not invest in a complete quality system and then develop your SaMD. You should either develop both in parallel, or you should develop your SaMD first. The only processes that are really important to implement at the beginning of product development are 1) design controls, 2) software development, 3) risk management, and 4) usability engineering or human factors testing. You can wait to implement the other 20+ procedures until you are entering the design transfer phase of your design and development project.

Do you need separate procedures for design controls, change control, and software development?

If you are developing a complex system that includes hardware and software you should probably have three separate procedures. The reason for this is that there are different quality systems and regulatory requirements for changes to hardware and software. If you are only developing SaMD, then you can easily combine these three processes into one procedure. The video at the beginning of this blog describes how to combine these three into one procedure, but the following outlines the software documentation that should be covered in each stage of your design process:

  1. Phase 1 – Design planning requires identification of the software risk classification (i.e. A, B, or C) in accordance with IEC 62304, and the Level of Concern (LoC) for your software in accordance with the FDA guidance for software documentation. Regardless of what the LoC is for your SaMD, you will still need to develop the documentation required for the risk classification in IEC 62304–even if the FDA does not want to review all of that documentation in your 510(k) submission. You will also need to identify the regulatory pathway for your SaMD. Your design plan will identify the team members and each person’s role and responsibility. This phase is when you should document your software development environment, create a draft software description, and create a draft software architecture diagram.
  2. Phase 2 – Design inputs must be documented and approved in the second phase. These inputs are testing requirements. Therefore, you need to develop a testing plan for your product based upon the regulatory pathway for that product, recognized international standards or common specifications, and any guidance documents that are specific to your type of SaMD. Typically, it is recommended to review your testing plan with a regulator in a pre-submission meeting prior to conducting your verification and validation testing–especially if animal preclinical studies or human clinical studies are required. This phase is when you should conduct a hazard analysis and approve your software requirements specification (SRS). The hazard analysis should include use-related risk analysis (URRA) and cybersecurity risk analysis.
  3. Phase 3 – Design outputs are iteratively developed during the third phase. This is typically the longest phase of your development process, and the “Waterfall Diagram” is not an accurate depiction of most software development processes. The “V-Diagram” presented in IEC 62304 is a better representation of the software development process because you continuously repeat steps as you debug your code and add functionality to your software. Only the simplest firmware is written in a linear fashion without multiple debug and retest cycles, and lean product development methods (i.e. Agile programming) are intended to be iterative. This phase of development is complete when you conduct a “design freeze” and begin your verification and validation testing. Typically, companies that are developing SaMD can complete most of their unit testing and integration testing prior to the design freeze, but system validation may not be conducted until phase 4. Unfortunately, the unit testing and integration testing can only proceed so far if you have an embedded system (i.e. software embedded in hardware). If the SaMD requires human clinical studies, that software validation is performed during Phase 4. Phase 3 is when you should be documenting your software design specifications (SDS), unit testing, and integration testing. Any formative testing required for the user interface would be done during this phase. Formative testing may include: 1) evaluating very software functions, 2) developing directions for use, and 3) developing a training program for users. You should write testing protocols for system validation and summative usability testing during this phase as well. It is important to identify all of the critical tasks related to use-related risks during this phase and document them. These critical tasks determine the summative usability testing required. It is also an excellent idea to start drafting a traceability matrix during this phase to ensure that each hazard and SRS item is being addressed in your verification and validation plan.
  4. Phase 4 – Design verification and validation of your SaMD are completed during this phase. At the end of this phase, you should have a complete traceability matrix, you should create a summary report of your unit testing and integration testing, and you should create a system validation report–including any benchtop, animal, or human performance testing is conducted. You should also create a revision history document and a bug report identifying any known bugs in the software with a justification for why the software is safe to release with these bugs. This phase is also when you should complete your risk management file and your summative usability testing report. Finally, you need to complete a final draft of your user manual for the software that includes directions for use and the indications for use. When all of this documentation is completed, you are ready for your regulatory submission.
  5. Phase 5 – Product release is the last phase of design and development. Once you receive 510k clearance for your SaMD, then you can begin the final release of your product. You will need to update your “splash” or “about” screen for the software to include a Unique Device Identifier (UDI). The information will need to be uploaded to the FDA’s GUDID. You can assign the DI for the UDI anytime, but the GUDID data elements cannot be finalized until you have 510k clearance from the FDA. You will also need to manage revisions of your software for this minor change and revalidate the code. This type of change will not require a new 510k, because it is a minor device modification. However, you will need to review the FDA guidance on software changes for other types of software revisions you make in the future.

Should you outsource software documentation for software as a medical device (SaMD)?

You can outsource all of your software documentation for a SaMD, but the person(s) creating that documentation will still need the documents mentioned in phase 2. If you do not provide any documentation of hazards, a software description, or a crude sketch of your software’s architecture, it will be nearly impossible for anyone to create your software documentation. It is also extremely expensive to outsource software documentation. Even if you do outsource this task, you still will need to review and approve that documentation. Most people outsource tasks because they don’t know how to do it, but it is critical for medical device companies to learn how to document their software development because they will need to maintain that documentation when the software is updated to fix a software bug or to patch cybersecurity weaknesses. Everyone that is developing software for a SaMD should receive basic training on the requirements of IEC 62304 early in your project. Your team does not need to be an expert in IEC 62304, but you need to create draft documents that you can present to experts for feedback. Your team should also review all four of the guidance documents that the FDA released for software documentation:

  1. General Principles of Software Validation (2002)
  2. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)
  3. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2014)
  4. Postmarket Management of Cybersecurity in Medical Devices (2016)
  5. Off-The-Shelf Software Use in Medical Devices (2019)

Creating your documentation is the hard part that your team should be doing while reviewing and editing your documentation is a great task to hire an expert consultant for your first SaMD project. This will ensure your team is writing the software documentation to the correct level of detail, and that you are not missing anything critical. Expert consultants can also provide you with templates for your software documentation.

Does software as a medical device (SaMD) require an electronic quality management system (eQMS)?

There are two types of quality systems: 1) paper-based, and 2) electronic. Most start-up companies chose the paper-based option because they don’t want the extra hassle of having to validate an electronic system. However, if your company is smart enough to validate SaMD, you are smart enough to validate software for your quality system too. The applicable standard for validation of software tools is ISO/TR 80002-2:2017. You can also purchase templates for software tool validation from Medical Device Academy. Companies are always asking for a referral of which eQMS system to purchase. The problem is that every year software has more functionality and costs less. Therefore, my general advice is to never pay more than $10,000 for eQMS as a start-up and consider starting with free database software to organize all of the documentation that is in your traceability matrix. You can migrate the data into an eQMS later by mapping your free database to the new eQMS software database.

Who should be responsible for QA and RA for software as a medical device (SaMD)?

Quality and regulatory are two different functions, and it doesn’t always make sense to have one person be responsible for both requirements. The two primary standards that are applicable to the quality assurance of SaMD are 1) IEC 62304, and 2) ISO 13485. Anyone you are considering for the position of quality manager should be familiar with both standards, and they should be making sure that your development team is documenting the software verification and validation as you proceed through the iterative software development process that is typical of Agile software development teams. The person doesn’t need to be able to code software, but they should be able to help review software documentation and suggest changes. This person’s role is extremely important to make sure that software revisions are managed properly, your software is only released when all of the validation and revalidation are complete. This person should also be able to determine if a new 510(k) is required for software modifications.

The regulatory process is the preparation of the 510k submission and communications with the FDA. This is an activity that you will probably need to perform once every two years. The FDA requirements for a 510k change more frequently than once every two years, and it is extremely difficult to become proficient when you are filling out government forms so rarely. For these reasons, it is recommended to work with an expert regulatory consultant with SaMD experience until your company has enough software products and revisions that you need to file multiple 510k submissions each year. Therefore, a less experienced quality manager can gradually learn the regulatory requirements over time and they will need less help from a regulatory consultant each year.

How do you measure quality for SaMD?

A lot of software developers struggle with identifying quality metrics if they are developing software as a medical device (SaMD). There are many aspects of software development that you can measure. Here’s a list of examples:

  1. customer feedback
  2. the velocity of Agile sprints
  3. coding errors
  4. what is the development lead time?
  5. how fast does the software load?
  6. technical support requests
  7. software configuration errors
  8. duration of software validation
  9. software validation documentation burden
  10. post-market surveillance of use errors
  11. How many software bug remain?

Do you need a corporate office?

Many MedTech companies are virtual companies, but the FDA will require a physical address to visit for an FDA inspection. FDA inspectors have visited the home of the company founder at other companies, but you probably will be more comfortable with an office space for the FDA inspector to visit. The FDA is unlikely to visit your company during the first year after you initially register your product. An inspection is more likely in the second year after initial registration and listing. Therefore, you might consider renting a co-working space where you can reserve a conference room if an FDA inspector visits. If you don’t have the funds to afford rent until after you launch your product, don’t worry. FDA inspectors are unlikely to visit so soon, and if they do–just relax and be honest about the situation. You are not alone.

About the Author

Rob Packard 150x150 Software as a medical device (SaMD)

Robert Packard is a regulatory consultant with 25+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at 802.258.1881 or by email. You can also follow him on Google+, LinkedIn, or Twitter.

Posted in: Design Control, Software Verification and Validation

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Contract Manufacturers Need Strong Risk Management Processes

This blog discusses why contract manufacturers need to have a strong risk management process, and your company needs to help your contract manufacturers. This article was updated on April 28, 2022, and the original publication was January 05, 2011. Please ignore the date of publication at the top of the post for articles that are more than a year old.

Risk management is not our responsibility Contract Manufacturers Need Strong Risk Management Processes

Can contract manufacturers exclude risk management from the scope of their quality system?

Most contract manufacturers in the medical device industry exclude design from their Quality Management Systems. Unfortunately, most of the contract manufacturers also associate risk management with only the design process. Risk Management cannot be “not applicable” in an ISO 13485 Quality Management System. The requirement of section 7.1 is: “The organization shall establish documented requirements for risk management throughout product realization. Records arising from risk management shall be maintained.” The Standard also references ISO 14971 as a source of guidance on Risk Management.

Medical Device Academy also offers a Two-Part Risk Management Training Webinar for ISO 14971:2019.

Have you experienced an audit dialogue at a contract manufacturer similar to this?

The auditor asks, “How do you manage risk throughout the production process?” Then the auditee responds, “That is the responsibility of our customers. We will prepare a risk analysis if customers pay for it, but usually, customers do the risk analysis.”

For a contract manufacturer, compliance with ISO 14971 is not my primary concern as an auditor. My primary concern is to verify that contract manufacturers analyze risks associated with the processes that they perform and do their best to minimize those risks. What I don’t understand is why more companies don’t want to have strong risk management processes. Risk management is how we prevent bad things from happening. Bad stuff like scrap, complaints, and recalls. Should we expect our suppliers to have a strong risk management process?

Duh.

Why your company needs to be involved in the risk management process?

Risk is a process 1 1024x1024 Contract Manufacturers Need Strong Risk Management Processes

Contract manufacturers should be doing everything they can to get better at risk management. During pre-production planning, they should be asking, “What happens if…” The contract manufacturer knows best HOW things will fail in production, while the customer knows best WHAT happens when things fail in production. To be safe and effective, both companies need to collaborate on risk analysis.

In any risk analysis, you need to estimate the severity of potential harm and the probability of occurrence of that harm. For production defects, the contract manufacturer can estimate the probability of occurrence of defects (i.e., P1 in Annex E of ISO 14971:2007), but the likelihood of occurrence of harm is less. The probability of occurrence of harm is the product of multiplying P1 and P2. The probability that occurrence will result in harm is P2, and P2 is a number that is less than 100% or 1. Your company can gather pre-market clinical data and post-market clinical data to estimate P2, but before launching your product, you can only guess at the value of P2. Your contract manufacturer, however, is not able to estimate P2 at all. It’s ok to estimate risk without P2 during the design phase because this will overestimate risks and result in more conservative decisions.

In addition to P2, your contract manufacturer is also not capable of estimating the severity of potential harm. As the designer of the medical device, you will know best how your device is used and what the likely clinical outcomes are when a device malfunctions. There may even be multiple possible clinical outcomes. The contract manufacturer knows what can go wrong during manufacturing, but you will need to define the clinical outcomes due to malfunctions.  

Why do contract manufacturers avoid doing risk analysis?

The reason contract manufacturers avoid doing risk analysis is because it’s time-consuming and tedious.

Too bad, so sad.

Balancing my checkbook is time-consuming and tedious too, but I balance my checkbook to prevent an overdraft charge. Not doing a risk analysis can be much more painful. Scrapping out a part can cost tens or hundreds of dollars. Complaints can cost thousands of dollars. Recalls can cost millions of dollars.

If I owned a contract manufacturing company, I would ensure that everyone in the company is involved in risk management. We don’t want scrap, we can’t afford mistakes that lead to complaints, and a recall could put us out of business.

How Medical Device Academy Can Help? 

Medical device academy can help both the contract manufacturer and the specification developer utilizing a contract manufacturer as a supplier! We offer training on 14971:2019 as well as procedures on risk management and supplier quality management.

Two-part Risk Management Training Webinar for ISO 14971:2019 – Part 1 of this webinar will be presented live on Tuesday, March 29 @ 9-10:30 am EDT. Part 2 of this webinar series will be presented live on Tuesday, April 5 at 9-10:30 am EDT. Purchase of this webinar series will grant the customer access to both live webinars. They will also receive the native slide decks and recording for the two webinars.

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Posted in: ISO 14971:2019 (Risk Management)

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Supplier Qualification: How To Get The Best Results

supplier SOP Supplier Qualification: How To Get The Best Results

This article discusses how to utilize various strategies for obtaining greater results related to supplier qualification. This article was updated on April 21, 2022, and the original publication was November 17, 2010. Please ignore the date of publication at the top of the post for articles that are more than a year old.

(Check out our procedure- SYS-011 Supplier Quality Management).

Supplier Qualification in ISO 13485:2016

Section 7.4 of EN ISO 13485:2016 states that companies shall “evaluate and select suppliers… based on their ability to supply product in accordance with the organization’s requirements.” This requirement is quite vague, but the medical device industry has developed a surprisingly limited number of approaches to address the requirement of this clause.

The most common approach is to ask for some combination of the following:

  1.  ISO certification,
  2.  a copy of the Supplier’s Quality System Manual,
  3.  completion of a Supplier Questionnaire and
  4.  performing a Supplier Audit.

Unfortunately, all four selection criteria are flawed.

ISO Certification

I think the best way to explain why these criteria are flawed is to use an analogy. Let’s compare qualifying a new supplier with recruiting a new employee. ISO certification is sort of like a college degree. You can make some general assumptions about a potential job candidate based upon which school they got their engineering degree from, but the degree is still just a piece of paper on the wall. As the old joke goes:

           ” What do you call the person that graduated last in their class at medical school?

           Doctor

Some registrars have a better reputation than others. Still, the name of the registrar is only as good as its worst client—who had four major nonconformities during their last audit and is about to lose that certificate. To improve this approach to supplier qualification, a potential customer could ask for a copy of the most recent audit report. This information is dependent upon the quality of the audit, but this would be a significant improvement over requesting a copy of the certificate.

caution sign picture warning 6699085 960 720 Supplier Qualification: How To Get The Best Results  CAUTION: Audits are still just samples—tiny samples. 

Again, like degrees, certification must be relevant. ISO 9001:2015 may be a ‘nice-to-have’ quality for potential suppliers. However, it doesn’t hit the mark if you need them to have ISO 13485:2016 certification. Perhaps you need a European Normative version, or A11:2021 as well. For example, sometimes any law degree might be appropriate. Sometimes you specifically need a degree in healthcare law. 

This makes it important to establish the criteria for your supplier evaluation early on in the process. Not just because it is required for standard compliance. It is difficult to evaluate a supplier with no guidance on how or what to evaluate them against. 

Supplier Quality Manual

The second selection criteria mentioned is The Quality Manual. The Quality Manual is analogous to a resume. The purpose of a resume is two-fold: 1) to provide an interviewer with information, so they can ask the interviewee questions without looking like an idiot, and 2) to provide objective evidence that a company did not illegally discriminate against a candidate that the hiring manager did not like.

I suppose you could argue that the purpose is to help candidates get a job, but in my own experience, less than 10% of resumes submitted result in a job interview—let alone a job offer. The purpose of a Quality Manual is NOT to help a company get new customers. If I am wrong about this, I need to do a much better job of marketing my Quality Manuals in the future.

Some suppliers have the nerve to say that their Quality Manual is proprietary. Humbug! Proprietary information should not be in the Quality Manual. You can copy a manual from another company and edit a few of the details. I will gladly write you a Quality Manual in less than a week that will pass any auditors review. You can even buy a Quality Manual online (In fact, Medical Device Academy sells one… Online! POL-001 Quality Manual). This almighty document just explains the intent of the Quality System—which is to conform to the requirements of the ISO Standard. Several auditors will tell you that this can be done in just four pages.

When you request a Quality Manual from a supplier, your primary intent for supplier qualification should be to use this document for planning a supplier audit. Any other purpose is just a waste of your time—unless you need to write a Quality Manual of your own.

Supplier Qualification Questionnaire

The third selection criteria I mentioned was: a supplier questionnaire or supplier survey. Questionnaires are analogous to employment applications. Coincidently, supplier questionnaires are often required by companies when a Quality Manual or ISO Certificate is not available. Do you find the similarities eerie?

Questionnaires are typically 15-20 page documents that someone has plagiarized from a previous employer. I have seen various versions of this questionnaire, but several of them appear suspiciously similar. Hmmm?

I am not sure what the original intent of this type of document was, but I think it was intended to capture detailed information about potential suppliers for a company in the Fortune 500®.

For most companies, 80% of the information on the questionnaire is meaningless. Customer requirements for a supplier are typically few in number and specific to the product or service being purchased. Therefore, please use your MRP system as a template and ensure that the questionnaire answers all the information you need to add the supplier to your system as an approved supplier. You should also have a product or service specification that gives you some more questions to ask.

Ideally, your questionnaire will be organized in the same order that you enter the information into the MRP system. Then this questionnaire will make the data entry easier for the purchasing agent, adding the supplier to the database. Questionnaires and surveys are great, but brevity is next to Godliness.

Supplier Qualification Audits

Finally, we come to the auditor’s favorite—supplier audits. Audits are similar to job interviews. Ideally, you want a cross-functional audit team, and you might need to visit more than once. Unfortunately, most companies cannot afford to audit every supplier. Some companies suppliment with remote audits. I guess I think of a desktop audit as a “phone interview.” I use phone interviews to prescreen candidates before I pay more money and waste other peoples’ time with on-site interviews. Desktop audits of suppliers should not be used as a replacement to an on-site audit, so your supplier quality engineers do not have to spend so many nights at the Hampton Inn.

If audits are your best selection criteria, how can you make the most of your auditing resources? Also, how can you audits for supplier qualification if you only have enough auditors to audit 5% of the approved supplier list? I have the following suggestion: “Start at the end.”

ISO 13485:2016 Clauses 8.5.2 / 8.5.3  CAPA

What I mean by this cryptic, four-word phrase is that auditors should start at the end of the ISO Standard with sections 8.5.2 & 8.5.3 (Corrective and Preventive Action (CAPA) Process). This is the heart of a Quality System. If you disagree, remember that FDA inspectors are required to look at the CAPA system during every Level 1 inspection. Registrars also look at the CAPA process during every assessment—not just the certification audits. The purpose of the CAPA process is to fix problems, so they don’t come back—ever.

If you think that a new supplier is never going to make a mistake, you might as well quit looking. You want suppliers with strong CAPA systems. If a supplier has a strong CAPA system, problems will be fixed quickly and permanently. To sample the CAPA process, an auditor only needs the following: 1) the CAPA procedure(s), 2) the CAPA log(s), and 3) a handful of completed CAPA records—selected not so randomly from the log(s). This can all be done remotely in a desktop audit. If suppliers are resistant to giving you the log or actual records, ask them to redact any sensitive information. If you have executed a nondisclosure agreement, the supplier should agree with this approach.

Analysis of Data for Supplier Qualification

ISO 13485:2016 Clause 8.4 Analysis of Data

Working from the back of the Standard, the next process to sample is clause 8.4 (Analysis of Data). There are four requirements of this clause. If the company has a requirement for customer satisfaction to be measured (ISO 9001:2008 section 8.4a), this is a great place to focus. There are also requirements to look at the trend of product conformity (8.4b), process metrics (8.4c), and trends in supplier data—such as on-time delivery and raw material nonconformities (8.4d). The quality of the analysis will tell an auditor as much about the company as the data itself. This process audit can also be performed remotely as a desktop audit.

A lot has changed since this article was first written. For example, if your potential supplier isn’t using ISO 9001:2015 you may want to verify that other areas of their quality management system aren’t outdated as well. 

ISO 13485:2016 Clause 8.3 Control of Nonconforming Materials

Clause 8.3, Control of Nonconforming Materials, is the third area to look at. To sample this area, you will need the “Holy Trinity” again: 1) procedure, 2) log, and 3) records. In this desktop audit, you want to look very closely at any nonconforming materials that are reworked or accepted “as is” (i.e., UAI). Either of these two dispositions should be ULTRA-RARE. Everything else should be processed efficiently as scrap or Return To Vendor (i.e., – RTV).

If a potential supplier passes all three “tests” described above, you are ready to address clause 8.2.4—Monitoring & Measurement of Product. In this section, there is a requirement to maintain records of product release and to verify that product requirements are met. for supplier qualification, if you think you can effectively audit this by paperwork alone, the supplier is a good candidate for “desktop only.” However, if the lot release paperwork, batch record, or Device History Record (DHR) is a 50-page tome—then you better make your flight plans.

The good news is that very few suppliers will pass the first three tests and implode during the on-site audit. Also, with three process audits complete, you should be able to reduce the duration of your on-site audit. Finally, for low-risk suppliers, you have a strong basis for provisional approval of suppliers to proceed with prototype runs before you schedule an on-site audit.

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Posted in: Supplier Quality Management

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What is 510k Content Format

This article defines the 510k content format for an FDA 510k pre-market notification submission in accordance with the September 13, 2019, FDA guidance.

image 1 What is 510k Content Format

What is a 510k?

A 510k submission is a pre-market notification submission to the FDA. The “510(k)” designation refers to the applicable section and sub-section of the Food Drug & Cosmetic Act. The “pre-market” designation is a reminder that companies must submit a 510k submission before marketing their products. Finally, the “notification” part of the phrase is used instead of the word “approval” because the FDA does not consider the 510k review process to be an endorsement or approval of your product. Instead, the 510k review process is a review by the FDA to determine if your product meets the requirements of substantial equivalence with a predicate device. The FDA initially performs a prescreening of the 510k submission to verify that it meets the minimum requirements for 510 content format. Then during the 510k substantive review process, the reviewer must answer six questions in the substantial equivalence decision tree:

  1. Is the predicate device legally marketed?
  2. Do the devices have the same intended use?
  3. Do the devices have the same technological characteristics?
  4. Do the different technical characteristics of the devices raise different questions of safety and effectiveness?
  5. Are the methods acceptable?
  6. Do the data demonstrate substantial equivalence?

The 510k process was not intended to be the primary process for regulatory approval by the FDA. The 510k process was intended to be a simplified approach for clearance of devices that are of moderate-risk and similar in design and intended use to another moderate-risk device that is already on the market. However, the process was manipulated as a loophole by device companies to avoid the more rigorous pre-market approval (PMA) process that requires conducting a clinical investigation.

Recent changes to the 510k review process are much deeper than the 510k content format

In approximately 2010, the FDA gradually started making changes to the 510k process. The FDA started publishing more guidance documents specifying both collateral guidance documents that apply to all device classifications (e.g., biocompatibility and human factors ), and particular guidance documents that apply to only a small number of product classifications (e.g., CADe). In 2012, the FDA implemented a new policy called the Refusal to Accept (RTA) Policy for 510(k)s. The FDA implemented this policy to improve the general quality of 510k submissions. All submissions are now subject to a 15-day review of the 510k content format to ensure that the submission includes all 20 required sections required by the FDA, the submission includes a table of contents and page numbering, and the various sections of the 510k include basic elements that are frequently forgotten by companies. Initially, more than 60% of the 510k submissions were rejected during the RTA screening process. Still, submissions have improved, and training of the FDA personnel performing the RTA screening has resulted in a more consistent application of the RTA policy. The FDA also systematically converted each of the remaining Class 3 devices that were eligible for 510k clearance to Class 3 devices requiring a PMA. The most recent changes were the elimination of requiring the submission to include a printed hardcopy of the submission (i.e., FDA eCopy only) and no longer allowing predicates that are more than ten years old.

FDA requirements for 510k Content Format

The FDA requires that your 510k submission is organized into 20 sections as described in section V of the table of contents of the September 13, 2019, FDA 510k guidance document. The FDA no longer requires a hardcopy of the submission. Now the FDA only requires an electronic copy (i.e., FDA eCopy) with a hardcopy of the 510k cover letter. The cover letter may be included in the eCopy, but it is not required. The FDA eCopy guidance document was updated on December 16, 2019.

The FDA eCopy guidance gives you the option of organizing the 20 sections of a 510k into 20 volumes with multiple documents in each volume or to submit sequentially numbered documents. The word “volume” refers to electronic folders in the FDA eCopy rather than physical binders. There is no right or wrong choice regarding volumes—if your eCopy uploads. The answer to this question is personal preference. The FDA recommends that multiple volumes be used for more extensive submissions, but using the same process for every 510(k) submission makes submission teams more efficient. It also is more comfortable for the FDA to navigate between documents when they are not in separate volumes. Therefore, the document structure is generally best for the FDA, and the volume structure is usually best for the company to prevent the need for renumbering files and file names. We always use the volume structure for every submission, even pre-submissions. Submissions are organized into 20 volumes to match the 20 sections of a 510k submission. If we include an RTA Checklist, then we add a 21st volume. The FDA recommends using the 21st volume for miscellaneous appendices, but the volume structure of the submission makes it easy to insert miscellaneous content directly into the applicable sections by adding documents after the initial section summary document.

Overall Numbering or Numbering within Sections?

Again, this is a personal preference. However, there are always last-minute changes to documents. Therefore, whichever numbering system you use should minimize the need for the last-minute renumbering of the entire submission. This is especially painful when you number the overall submission, and then you add a page to the middle of the submission when you are trying to ship out your submission that day. By numbering only the sections, you reduce the amount of rework required. Our firm deviates slightly from the “numbering within sections” requirement. In the table of contents, we indicate how many pages are associated with each document in a volume, and then we start each document with page 1. One FDA reviewer recently requested that we modify this to “page x of y,” where “x” is the page number of that document, and “y” is the total number of pages in the document. Therefore, we updated all of our templates to reflect the “page x of y” format for page numbering.

510k Format Content: Using Your Table of Contents for Project Management

When I was less experienced, I used project management software and action item lists to manage submission projects. Experience has taught me to simplify. Now I only use an action item list to track the progress of individual tasks. To track the overall submission, I now use the table of contents as my project management “report.” If you color-code the rows of your table of contents, you can communicate the status of each document in the submission. At the beginning of the project, all the rows indicate documents are not yet started—signified by the color red. Once I being a document, I change the color to yellow. Finally, when the document is completed, I change the color of the row to green. Three documents require the signature of the official correspondent with the FDA:

  1. 510k Cover Letter
  2. Certification Regarding Confidentiality
  3. Truthful and Accuracy Statement

Once these three documents are completed, they still need a signature that should only be applied just before we prepare the eCopy. Therefore, I signify the status of documents waiting for signatures with blue rows. A couple of people struggle with reformatting row colors, but every single person on your team will understand that they want the table of contents to gradually change from red, to yellow and finally to 100% green.

Posted in: 510(k)

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Why remote audit duration should never exceed 90 minutes

This article explains why remote audit duration should not exceed 90 minutes and the unique opportunities created by a series of short remote audits.

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Parkinson’s Law and the subject of audit duration

On November 19, 1995, Cyril Northcote Parkinson published an essay in the Economist. The title of the article was “Parkinson’s Law.” In the first sentence of the essay, Parkinson says, “It is a commonplace observation that work expands to fill the time available for its completion.” This essay refers to the observation that work is elastic concerning the demands on time when completing paperwork. When I first trained as an auditor, trainers emphasized that the most significant challenge faced by auditors is to complete an audit within the time available. An auditor’s task is to achieve the audit objectives within the time specified by the audit program manager. Time is precious, and you cannot easily extend the audit duration after scheduling the audit.

How much time is needed for a full quality system audit?

This question is a silly question to ask a consultant that works on an hourly basis. A consultant working on an hourly basis will make more money if they work more hours. Therefore, there is little incentive to underestimate the time required to complete the objectives of an audit. However, after completing hundreds of audits, I can honestly state that eight hours is not enough time to perform a full quality system audit of a medical device company’s quality system. However, I completed a full quality system audit of a small company in less than two days. I also had difficulty completing an audit of a larger company in four days. An FDA inspector typically requires four days to complete a routine inspection, even at foreign manufacturers where English is a second language, and they only need to return on the fifth day to prepare their FDA 483 observations to give to the company. Therefore, three days is typically the absolute minimum time required to complete a full quality system audit.

Does Parkinson’s Law apply to audit duration?

Parkinson’s Law certainly applies to the audit duration. If the lead auditor assigns a team member to review the CAPA process, the task is unlikely to be completed in 30 minutes, and most auditors would struggle to appear busy for more than three hours. You need enough notes to provide objective evidence of conformity for your audit report, but if you finish too quickly, then others may perceive that you were not thorough. Therefore, most auditors will begin any process audit by asking for a copy of the procedure and a log of the records available. The auditor will quickly review the procedure’s revision history to determine when the last revision was made and if there have been any significant revisions since the last audit. Next, the auditor will review the log to estimate how many records should be sampled. The auditor will then estimate how much time is needed to review the sampled records. Finally, a quick mental calculation is made to determine how much time remains for procedure review before the auditor must move on to interview the next subject matter expert.

Why are auditors always behind schedule?

An auditor begins with small, close-ended questions that are designed to put the auditee at ease. The auditor may even comment on unrelated subjects to build rapport first. Records may not be readily available, but auditors almost always have to wait for record retrieval. The request is recorded, copies are made, and the subject matter expert may need a little time to review before handing the auditor the requested record. Auditors will ask clarifying questions, and auditees will need a few moments to check their facts. Any one of these delays is insignificant by itself, but collectively there may be two-and-half minutes of delay cumulatively for each record requested if you sample five records, which represents a combined delay 12.5 minutes. If you average only seven minutes to review each record, then a sampling of five records will require 47.5 minutes. This will leave you only 12.5 minutes for introductions, review of the procedure, and conclusions. If you want to interview any of the people that investigated root-cause, then you will need more than an hour to complete your audit, and you will not finish in the one hour scheduled.

Why is it so hard to complete a full quality system audit in three days?

Most of your process audits require a few more minutes than you expected, but you will also need time to walk to the next subject matter expert, or you will be waiting for the next subject matter expert to enter the conference room. If the quality system consists of only the minimum twenty-eight required procedures, your full quality system audit will require more than 28 hours to complete. If there are additional regulatory requirements for CE Marking or ISO 13485 certification, you will need even more time to audit every process. You should also expect certain processes to require more time to properly sample records, such as technical documentation and design controls. Even the most experienced auditors struggle to review a technical file and/or design history file in less than two hours.

What happens to an auditor after auditing all day?

As a Notified Body auditor, I used to leave my home in Vermont on Sunday afternoon and drive two hours to the nearest major airport. Then I would be gone all week conducting audits. On Friday, I would drive home and arrive in the middle of the night. Each day audits would begin early in the morning, and I would complete the day after 8.5 to 9 hours of work. Jet lag, sleep deprivation, too little exercise, and constantly eating at restaurants took its toll. I would consult my Google calendar to learn what city I was in each morning, and to remember what company I was on my schedule for the day. I would purposely try to do as much walking around during the day just to keep my blood flowing and to help stay awake. I would read documents while pacing back-and-forth in conference rooms, and I would always make sure that we had to audit the most remote area of a facility after lunch to make sure that I didn’t fall asleep. I will tell stories and jokes to entertain my hosts, but it was necessary to break up the monotony of auditing quality systems seven days a week. I would make sure I drank at least six liters of water each day for health, but this also gave me an excuse to go to take frequent bathroom breaks. Somehow I managed to survive that lifestyle for more than three years. Each day my feet, legs, back, and neck were in severe pain. I had constant headaches, and I know the quality of my work gradually declined throughout each day. The most valuable lesson I learned was, you need to move frequently, or you will die.

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What happens when you sit in front of a computer for eight hours?

I can sit in front of a computer longer than almost anyone I know. When I focus on work, four hours can elapse without me getting up from a chair even once. I might pick up my empty coffee mug four or five times to take a sip before I am conscious of the need to get another cup. On days where my schedule consists primarily of Zoom meetings, I may sit through as many as six consecutive meetings before I take the time to get up and go to the bathroom and get a drink of water. Clients may perceive that I have tremendous endurance, but there are negative consequences to this work pattern. My wrist becomes sore, and I need to switch my mouse pad and the style of the mouse I am using every day. I change computers, switch microphones, and take a short walk. My neck, back, and legs will hurt worse than any of the audits during my years as a Notified Body auditor. Sitting at a computer all day has resulted in mild symptoms of restless legs syndrome. Sitting at a computer continuously for the audit duration is physically exhausting and tedious. If you must complete a remote audit on a continuous eight-hour day, you can, but it is not healthy or productive. The negative health consequences and negative impact on productivity are equally applicable to auditees.

What can you do to reduce audit fatigue during a remote audit?

The most straightforward strategy for reducing fatigue is to take breaks. Instead of auditing for eight hours continuously, try auditing in two or three 90-minutes segments each day. If you are auditing someone in a different time zone, you may only be able to accommodate an audit duration of one 90-minute session per day without working through the night. Taking breaks will allow you to leave your computer, eat food, and even go to the bathroom. You can recharge your headset during a break too. You should consider taking a walk outside. It is incredible how much better you feel when you get some exercise, stretch, and experience a little natural light instead of the unnatural glow of your computer’s monitor. The person you are auditing will appreciate the breaks, but they will also enjoy the improvement in your overall demeanor. A simple smile after a 30-minute break has a tremendous positive impact.

How can we utilize breaks more effectively during remote audits?

Auditors need documents and records to review as objective evidence. The most obvious way to make use of breaks is for the auditor to give the auditee a list of documents and records to gather during the break. This will give the auditee an excuse to go and get the documents and records if they are stored in another location. The auditee might also scan records during a break. A break also gives subject matter experts time to re-familiarize themselves with the documents and records before resuming the audit. Auditees and auditors will need to recharge batteries, but the auditor might take time to convert their notes into a summary for the final audit report. The auditor might also review the audit criteria one more time before writing a nonconformity. The auditee might take advantage of the break to initiate a new CAPA and write a draft of the corrective action plan. Then when the audit resumes, the auditee can review the draft plan with the auditor to ensure that the plan is appropriate and nothing was accidentally omitted from the CAPA plan.

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Why are 90 minutes a magical audit duration?

Auditing one process in a single 45-60 minute session is ok, but if you audit two processes in a single 90-minute session, you can reduce the time spend starting and stopping the audit session by half. Adding a third process to a single session will have a smaller impact, and the meeting will need to be so long that most participants will begin to lose concentration, and fatigue becomes a significant factor. Ninety minutes is not quite long enough to audit two processes effectively. Still, an auditor can request procedures in advance of the session or spend time after the session reviewing procedures. Therefore, by paying an additional 30 minutes reviewing two procedures “off-line,” the auditor can dedicate 100% of the “on-line” time to reviewing records and interviewing subject matter experts. The result is a fast-paced, 90-minute session where each subject matter expert typically is only needed for 45 minutes. Alternatively, if you are auditing more complex records like a design history file, you can spend all 90 minutes discussing that area.

Posted in: Auditing, ISO Auditing, Remote Auditing

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How to make a supplier questionnaire for remote auditing

You already have a supplier questionnaire, but do you know how to make a supplier questionnaire to assess a supplier’s ability to support a remote audit?

FRM 004 Supplier Questionnaire How to make a supplier questionnaire for remote auditing

The four most significant mistakes people make when designing a supplier questionnaire

In Medical Device Academy’s supplier qualification webinar, you learn how to improve your supplier qualification process by replacing the traditional methods of supplier qualification with more effective approaches to supplier evaluation. The following are four examples of how to improve your supplier questionnaire.

Supplier questionnaires should be specific to the product or service provided

The first mistake people make is to use a generic questionnaire. It would be best if you asked your supplier questions that are important to the work that the supplier will be performing. Therefore, each category of product or service should have its own set of questions. For example, important questions related to ethylene oxide contract sterilization services are the maximum size limitations for pallets in the sterilization chamber and whether the facility can conduct sterility testing on-site. However, an injection molding supplier might delay the return of your supplier questionnaire if these questions were on the survey that you send to them because they don’t understand the questions.

Supplier surveys should be more than checkboxes

The second mistake people make is to ask questions that can be answered with a “yes” or “no” response or a checkbox. These are closed-ended questions. It would be best if you always were asking open-ended questions because the response will give you more information about the supplier. In addition, most people resist responding with a “no” response even if the real answer is “no.” For example, “What is your FDA registration number?” is more useful than “Is your company FDA registered?” Another example is, “How many production lines use SPC charts?” instead of “Do you use SPC charts?” In fact, in the open-ended version of this question, you will learn if the use of SPC charts is widespread, and you learn how many production lines the supplier has.

Remember to ask suppliers to update survey surveys every year

The third mistake people make is to request that a supplier questionnaire be completed only during the initial supplier qualification process. Every year companies grow, shrink, or change. If you ask suppliers to update their questionnaire, you can use that information to determine the health of your supplier’s business. You might also discover that one supplier just added a new production capability that will allow you to consolidate more of your outsourced work with that supplier and eliminate another problem supplier. Every company has a turnover in personnel as well. It is a great idea to ask suppliers to provide contact information for multiple people in the organization, such as quality contact, billing contact, and a production planner. Eventually, you will probably need to speak with each of these people, and if one of the contacts is no longer at your supplier, you will still have two other contacts. Updating this information also gives you a hint of whether turnover is widespread or limited to a specific individual.

Supplier questionnaires should be in spreadsheet format

The fourth mistake people make is to send a Word Document for suppliers to complete (PDF format is even worse). Word and PDF formats are time-consuming to complete, and they are harder for you to analyze than a spreadsheet. Most people provide a Word document or a PDF because they are focusing on the requirement for control of records. However, if you have an electronic quality system, the supplier survey information will be part of your electronic system as soon as you enter the data into your software. Alternatively, if you have a paper-based quality system, then you can print the spreadsheet out, sign it, and date it. The huge advantage of using Excel spreadsheets is that you can copy the new data into a column next to the previous year’s responses. Then you can quickly see what changes your supplier made in the past year.

What should you add to your supplier questionnaire?

Most private companies will not share what their revenues are for the business, but as a customer, you should be more concerned with how many human resources your supplier has. Therefore, you should consider asking, “How many employees, or full-time equivalents (FTEs), work for your company?” You might also want to know if your supplier is relying on a temporary workforce. For example, “What percentage of the FTEs are temporary workers?” Many questionnaires will ask for the square footage of the facility, but this doesn’t provide you with any details about the facility layout. Alternatively, you could ask for a copy of the pest-control map for the facility. This would give you a detailed layout of the facility, and it also confirms that your supplier has a pest control plan for the facility. Another related question to ask is, “Please describe any expansion/construction projects that have been implemented in the past year or projects that are in progress (e.g., the addition of a mezzanine).” If the company added 30,000 square feet to their production area, but there was no change to the pest control plan, you might have some clarification questions for your supplier. In general, a good strategy for developing your questionnaire is to think of at least one open-ended question related to each clause of the ISO 13485:2016 standard without referencing the standard. The following are some examples that might help you:

  1. When was the last software re-validation for quality system software?
  2. How many active external standards is your company currently maintaining?
  3. Please provide a list of procedures and identify the person who would be interviewed during an audit for each procedure (i.e., process owner or subject matter expert).
  4. In the absence of the management representative, who is designated as the liaison for an FDA inspector?
  5. What are the upper control limits for particulate counts, air viable counts, and surface viable counts in your controlled environment(s)?
  6. On what dates was the environmental monitoring of controlled environments conducted in the last year?
  7. Please identify how many quality inspectors are responsible for the incoming inspection?
  8. Please list the calibration ID and equipment name for any inspection equipment that requires specialized training (e.g., CMM)?
  9. How many suppliers are on your approved supplier list (ASL)? And how many suppliers did you audit in the past year?
  10. How many nonconforming material reports (NCMRs) were opened in the past year? And how many NCMRs currently remain open?
  11. How many partial or complete lots were returned to your company by customers in the past year?
  12. Please list any corrections and removals (i.e., recalls) that your company has been involved in during the past year and the current status?

How many questions should your supplier questionnaire include?

There are 28 required procedures in ISO 13485:2016, and there are even more subclauses within the standard. It is an excellent idea to create a list of questions you might ask for each subclause, but a supplier questionnaire should not include all of those questions. Just as audits are just a sampling, your supplier survey questions should be sampling as well. You should review last year’s questions and eliminate questions that you think are not especially useful for that supplier. Some questions should be asked each year to assess if the quality system has changed significantly, and you should consider adding a few new questions each year. The best questions will require the person to perform some research to answer the questions. But it is unreasonable to expect a supplier to spend more than two hours completing a supplier questionnaire if you plan to purchase less than $20,000 in product or services.

Supplier questionnaires specific to remote auditing

In many ways, a well-designed supplier questionnaire is similar to a remote audit, because you are asking the supplier to answer multiple open-ended questions about their quality system to verify that the quality system is fully implemented and remains effective. However, due to the Covid-19 pandemic, many employees are now required to work from home, and it is not possible to physically visit certain facilities. Therefore, you should be adding three elements to your supplier questionnaire to assess your supplier’s ability to support a remote audit and to determine their ability to maintain the effectiveness of the quality system during a viral outbreak. The three elements are 1) policies for personal protective equipment for employees and visitors, 2) business continuity plans to maintain internal operations and to ensure redundancy of crucial suppliers, and 3) availability of digital documents and records or paper documents and records via video conference software. These three areas were also the subject of a previous blog on changes triggered by Covid-19. It would help if you also asked about the availability of hardware and software communication tools for conducting a remote audit. You might ask your supplier, “Which areas of your facility can we observe during a remote audit using live video conferencing (e.g., Zoom mobile application)?” and “What experience does your company have in the use of Zoom as a video conferencing tool?”

Gimbal How to make a supplier questionnaire for remote auditing

Access to documents and records during remote audits

During a remote audit, you will need to access documents and records virtually. If your supplier can participate via a video conferencing tool with a high definition web camera or smartphone, then you should be able to see any documents and records that you could normally see during an on-site audit. However, your supplier will need to hold the document or records steady, possibly by using a music stand and a camera tripod so that you can take notes regarding the contents of the document or record. You will also need a way to record your notes. You might try using a Pixelbook or similar computer to write your audit notes. At the same time, you watch the video conference using a second computer–possibly on a conference room projector screen or large flat screen monitor. You could also use a tablet, such as remarkable. Of course, you can always use a pad of paper and a pen and then transcribe your notes later. All of these methods will be faster and more convenient than digitally scanning each document and uploading the documents to a shared folder or sending the scanned document by email.

It would help if you also were asking your supplier which records are already available digitally. You can expect all of the quality system procedures to be available in digital formats, but many records may already be available electronically as well. For example, purchase orders, quality system certificates, drawings, and blank forms should be available in digital format. In a supplier audit, you typically will focus on a subset of the quality system records that are related to production process controls, purchasing, incoming inspection, shipping, and control of the nonconforming product. Asking your supplier which of these records are available in digital format will help you determine which records you need to request from the supplier in advance and which records can be requested on-demand.

How to obtain our supplier questionnaire template (FRM-004)

If you are interested in purchasing our supplier questionnaire template, FRM-004, it is included with the purchase of our supplier qualification webinar. If you think of any new questions to add to this template, please email me at rob@13485cert.com. Just put “FRM-004 Suggestion” in the subject line.

Posted in: ISO Auditing, Supplier Quality Management

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How to avoid the most common supplier evaluation mistakes

The focus of this article is on the process of supplier evaluation and re-evaluation for medical device companies and how to document your evaluations.
No Grandfathering Image How to avoid the most common supplier evaluation mistakes

You have several suppliers today, but did you have a rigorous supplier evaluation process when you first hired those suppliers? If your business is going to be successful, you need to treat your supplier evaluation process as a critical strategic process. Supplier qualification and is more important than the hiring of any senior manager. ISO 13485:2016 requires you to have a procedure for supplier evaluation and re-evaluation, but the type and extent of your supplier controls are not specified.

Which of your suppliers are critical or crucial?

Crucial suppliers were defined in a draft policy published by the European Commission as part of the introduction of the requirement for unannounced audits. Essential suppliers make a component or subassembly that is high-risk, or your firm cannot easily purchase the component or subassembly from another supplier. Critical suppliers for medical device manufacturers fall into one of three categories: 1) a contract manufacturer, 2) a contract sterilizer, or 3) a contract packager or labeler. These three types of suppliers may be selected for unannounced audits by a Notified Body. The FDA also requires these three categories of suppliers to register their facility.

Should you establish other supplier evaluation categories?

The short answer is no. The purpose of categories is to ensure that a large number of suppliers are consistently managed. Instead, try reducing the number of suppliers you are managing. Give your best suppliers more work, and fire the worst suppliers. If a component is “single-source,” encourage another supplier to quote that business before you look for a new supplier. It would be best if you took the time to evaluate each supplier thoroughly. If you don’t have the supply chain resources to do this, then you have three choices: 1) hire another person to help manage your supply chain, 2) fire suppliers that are not meeting your requirements, or 3) replace the weakest member of your supply chain team.

How do you re-evaluate existing suppliers now?

There are a lot of possible answers to this question, but unfortunately, the most common answer is, “because that’s who we’ve always used.” This practice, referred to as “grandfathering,” is a horrible approach to supplier re-evaluation. Suppliers that miss your requested delivery dates, and suppliers that ship nonconforming product should be required to implement supplier corrective actions immediately. You need to follow-up on these corrective actions and verify that the corrective actions were effective. If the corrective actions are not effective, or if new supplier issues occur, then you should find an alternate supplier as soon as possible.

Another stupid reason for selecting a supplier is “because they were the lowest bidder.” There’s an old government contracting joke about this strategy. It sounds something like this, “a million mission-critical parts, designed by engineers that have no clue what the real world is like, built by the lowest bidder, and inspected by a bureaucrat that can be bribed with a bottle of wine and some prime rib.” I tend to discount the quality of the lowest bidder every time. I always wonder what they forgot to consider when they bid on the job. If the lowest bidding supplier can explain why they have an inherent advantage over their competition, then maybe you should consider hiring them. If there is no rational reason why a supplier’s pricing is below their competition, this usually means that the supplier is desperate, or they plan to increase their pricing after you are a customer.

What should be your supplier evaluation and re-evaluation criteria?

All medical device suppliers should have a quality system, but ISO certification is not required. Therefore, if a supplier has ISO 13485 certification, you might abbreviate your initial supplier qualification process. However, ISO 13485 certification should have minimal impact upon your on-going supplier evaluation process. You need to know how well your supplier’s quality system is being maintained. If your supplier is sharing copies of their annual surveillance audits and FDA inspection reports with you, this will give you a better indication of the quality system effectiveness.

Consider performing supplier audits for supplier evaluation

Although it is not required, the best way to evaluate the effectiveness of a supplier’s quality system is to perform a supplier audit. Specifically, you should focus on the processes that are directly related to your product or component. Production process controls and final inspection are the most critical areas to audit. Other areas that are important to consider for supplier audits are 1) incoming inspection, 2) purchasing controls, 3) shipping, and 4) control of nonconforming materials. Conducting a supplier audit using the process approach is the most effective method. The process approach method of auditing will ensure that document control, record control, calibration, process validation, and training are sampled as support processes. The supplier audits may also be conducted as on-site audits or remote audits.

Certificate of Conformity (CoC) vs. Certificate of Analysis (CoA)

Another supplier evaluation criteria should be product conformity. You should be reviewing more than whether your supplier shipped the correct product and the correct quantity. Did your supplier provide a Certificate of Analysis (CoA) that summarized the inspection methods, acceptance criteria, and the inspection results? Or do you verify that a Certificate of Conformity (CoC) was included and accept the lot you received? If your company is only receiving a CoC from a supplier, you should be sampling the product at incoming inspection and verifying that the product is conforming with your requirements. Even if the supplier is providing a CoA, you should still perform periodic sampling and inspection of the product to make sure the CoA provided matches the actual product you are receiving.

Considering Improving your supplier questionnaires

If your company is requesting that suppliers complete supplier questionnaires, make sure that you are asking the most relevant questions. You need to know if your supplier can support remote audits. You need to know if there have been any significant changes to the quality system. You need to know if the company has had any significant non-conformities resulting from certification body audits. You need to know if there have been FDA inspections and what the results of the inspection were. You should also be obtaining monitoring and measurement data related to process conformity and product conformity. Asking your supplier to identify any shutdown periods or planned renovations is a required input for critical and crucial suppliers for CE Marked medical devices subject to unannounced audits. It would help if you also were asking your supplier to update the names, titles, and contact information for key management personnel. Would you like a copy of our supplier questionnaire?

No Grandfathering Image 1 e1591549101295 How to avoid the most common supplier evaluation mistakes

What should you be doing to address the Covid-19 pandemic?

As a consequence of the Covid-19 pandemic, many suppliers have had significant disruptions to their supply chains, workforce availability, and transportation vendors. Since many medical device products are urgently needed during this pandemic, it is important to ask suppliers to provide a summary of their current situation and any analysis they have done to assess potential risks that could disrupt your supply chain. Does your supplier have adequate personal protective equipment (PPE)? What type of precautions is being taken to ensure that employees don’t exhibit symptoms of Covid-19 illness? Does your supplier have a policy for self-quarantining if an employee is exposed to someone that has the virus? Does your supplier have a disaster recovery plan?

Consider using size for supplier evaluation

Bigger is not always better. If you are a small customer of a large supplier, your needs will seldom be important to your supplier. Alternatively, if your company is much larger than your supplier, your supplier may not have the resources to grow with you and keep up with your current demand. When you are initially qualifying suppliers, try to select suppliers that are approximately the same size as your company or slightly larger. You should also consider identifying more suitably sized suppliers if you have a significant size mismatch or one develops over time.

What if you don’t have the resources to evaluate your suppliers?

Supplier evaluation and re-evaluation is a strategic function that impacts your profits, your ability to deliver product on-time to your customers, and nonconforming product can tarnish your company’s reputation. Therefore, your company needs to invest resources to analyze your supply chain. It would help if you had suppliers that have excellent quality and suppliers that will encourage your company to improve. Are there best practices you can learn from your suppliers? Is your supplier able to help you manage your inventory? Can your suppliers help you solve production problems? Supplier evaluation should only be secondary in importance to your design process and post-market surveillance. As they say, “garbage in equals garbage out.”

Do you need additional training on supplier evaluation?

On June 25, 2020, at 11 am EDT, and we are hosting a live webinar on how to qualify your suppliers. In this webinar, you will learn how to qualify new suppliers even if they don’t have ISO certification and best practices in supplier evaluation. We will be sharing a new supplier questionnaire that includes questions to help you assess whether a supplier is capable of supporting remote audits. We will help you develop a strategy for the allocation of supply chain personnel, and show you how to convince top management to prioritize supplier audits.

Posted in: Supplier Quality Management

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How to apply a risk-based auditing approach to audits and remote audits

In this article, you will learn what risk-based auditing is, and how to apply a risk-based approach to auditing and remote supplier audits.

animal nature reptile animal world How to apply a risk based auditing approach to audits and remote audits

Risk-based auditing considers the risks of failing to achieve audit objectives and the opportunities created by choosing various audit methods and strategies. For example, if you are conducting your first internal audit for a new quality system, a desktop audit of procedures might be appropriate. Alternatively, if you are auditing a mature quality system where very few changes to procedures have been made in the past year, a desktop audit would be a waste of time, and using the element approach to auditing is unlikely to add much value. Audits are meant to be a sampling. Therefore, you should focus on areas of importance, areas where previous nonconformities were identified, any new products or processes, and anything that changed significantly. 

The risk-based auditing approach is the most significant change in ISO 19011:2018

One of the main differences between ISO 19011:2018 and the previous 2011 version is the addition of a “risk-based approach” to the principles of auditing. Specifically, clause 4(g) of the guidelines for auditing management systems is, “The risk-based approach should substantively influence the planning, conducting and reporting of audits to ensure that audits are focused on matters that are significant for the audit client, and for achieving the audit program objectives.” A lot of people are unsure of what is meant by a risk-based approach, but the key to understanding this is to focus on the definition of risk. From a product perspective, the risk is the “combination of the probability of occurrence of harm and the severity of that harm.” From a process perspective, the risk is the “effect of uncertainty on an expected result” (ISO 9001:2015, clause 3.09). Therefore, auditors should emphasize medical devices that present the highest severity of harm and any devices that have a high probability of hazards or hazardous situations occurring. When an auditor is focusing on a process, rather than a specific medical device, auditors should emphasize any processes that are not under control and any recent process changes.

Auditor selection should also be risk-based

If you are conducting a supplier audit as part of your initial supplier qualification for a critical component supplier or contract manufacturer, you should consider doing a team audit with a multi-disciplinary team. This is a risk-based approach to the supplier qualification process, which ensures that you have subject matter experts evaluating each process instead of auditors with a general quality assurance background. This approach also forces more of your personnel to introduce themselves to the new supplier, and the audit will develop more reliable communication channels between your two companies. Alternatively, if you are conducting a routine internal audit of a production process, you might select a new lead auditor to conduct the audit. You don’t expect any significant findings in a routine internal audit of an established production process. In your role as an audit program manager, you need to match the new lead auditor to a process that will force them to look at all aspects of the process approach to auditing. Specifically, process validation, calibration, maintenance, and process monitoring are areas that may not apply to other administrative process areas such as purchasing.

Risk-based auditing should influence your auditing schedule.

The frequency of auditing suppliers and internal process areas should reflect the risks associated. Therefore, when you create or update your auditing schedule, you should consider the risk level of products being audited and the process being audited. Production processes with a moderate or high level of non-conforming products may need to be audited more than once per year. Still, a supplier with an excellent track record of extremely high quality and on-time delivery may be audited on alternating years. If you previously scheduled a remote audit, you may want to alternate to conducting an on-site audit the next time.

The duration of your audits should not always be the same either. If one production process makes one product in low-volume, and another production process makes multiple products in high-volume, you should not schedule a two-hour internal audit for both processes every year. The low-volume production process may only need a one-hour audit once per year. In contrast, the high-volume process may require a four-hour internal audit or multiple audits each year.

Risk-based auditing applied to remote supplier auditing.

The risk-based auditing approach was added to ISO 19011:2018 as the seventh principle of auditing. This represents the most significant change to that standard, but how does it apply to remote auditing? Despite the opportunities created by remote supplier auditing, there are also risks associated with auditing suppliers remotely. Most people worry about auditees hiding hazardous situations or unacceptable environmental conditions such as filth or disrepair. However, unacceptable cleanliness and maintenance practices don’t happen overnight. Therefore, you should expect a clean and well-maintained facility to remain that way. One approach is to alternate between remote and on-site audits to verify the overall condition of a supplier’s facility. Therefore, the risk of auditees hiding objective evidence is more an issue of trust than a highly probable occurrence.

The more probable risks associated with remote auditing are related to the potential lack of availability of records. This is especially important for paper-based quality systems. Most people try to address this risk by scanning paper documents and records, but scanning documents have limited value. Scanning paper documents is more efficiently performed in a large batch by an automated or semi-automated process. Also, auditors and inspectors typically focus on the most recent records, and auditors and inspectors rarely sample 100% of the records. Therefore, the best risk controls include:

  • Ask a guide to send a digital picture of the record.
  • Use a tripod-mounted HD webcam focused on a music stand or similar surface.
  • Ask the auditee to read the document while you take notes.

In our experience, you will probably rely on all three risk controls, but it is unlikely to delay the audit. However, in response to the limited physical access to medical device facilities and personnel, certification bodies are sending out questionnaires to assess the risk of being unable to achieve audit objectives or cover the required scope of surveillance and recertification audits. As the audit program manager, you can reduce these risks by working with supply chain managers to develop new supplier questionnaires that specifically ask questions about the capability of supporting audits remotely. In particular, it would be important to obtain facility maps to identify areas with inadequate cellular coverage and identification of records that are only available in hardcopy format.

 

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Remote audit resources – software and hardware tools

If you are planning a remote audit, you will need more remote audit resources than a webcam and web conferencing software. Matthew Walker is a significant contributor as co-author of this article.

20200525 095104 scaled Remote audit resources   software and hardware tools

Clause 5 of ISO 19011:2018 is titled “Managing an audit program,” and subclause 5.4.4 is specific to determining audit program resources. For conducting audits remotely, you will need remote audit resources. Almost every laptop has a built-in webcam and microphone, and that is the minimum functionality you will need to conduct a remote audit. However, adding other software and hardware technology can improve the efficiency and effectiveness of your audit team.

What remote audit resources do you need?

Remote audits are not the same as a desktop audit, because a remote audit requires remote access to more than emails containing procedures and records. Auditors need access to people and access to physical areas of your facility. This creates one of the most significant challenges for this type of audit method. Call me a Negative Nancy, but I suspect that most audit plans do not specifically include logistical preparations to support this audit method. On the surface, it seems like a simple concept. Internet access and a scanner should cover most of the needs for the auditee to survive this digital encounter. In practice, conducting a remote audit that genuinely adds value and does more than checkboxes, requires serious planning.

Let’s start with the obvious; a remote audit needs a way for the auditor and the auditee to communicate with each other. Ideally, you need more than your phone. We recommend Zoom for video conferencing, but we list several other video conferencing software applications below. Here are the features of Zoom that we typically use during a remote audit:

  • Video Chat – Using Zoom, two or more parties can communicate using video input from webcams. This is nice because it allows for a more visual conversation, and you can see more of the facial expressions and body language of the person you are speaking with than you can with a traditional phone call. It also allows for sign language to be used if necessary.
  • Screen Sharing – Screen sharing is an essential tool you will use during a remote audit because it allows you to share documents and records on your screen even if you are not the host. The more records you have electronically, the more valuable screen sharing will be during the audit. An auditor can say, “Can you show me that quality system certificate again?” or “Can you show me where Isomedix is on your approved supplier’s list?” Being able to facilitate those verification activities saves the auditee the hassle of emailing documents or uploading content to a shared folder. This ability to share your screen is also essential for an auditee to demonstrate training effectiveness and competency.
  • Recording – Meetings can be recorded in their entirety or sections. This allows the auditee to record the opening or closing meetings of the audit to share with others that were unable to attend. If there are questions regarding non-conformities or opportunities for improvement, a recording of the conversation ensures that the auditor has an accurate record of complex objective evidence that would slow down the audit and gives managers a perfect record to demonstrate the issue when corrective actions are initiated.
  • Chat Record – Zoom, and most other video conferencing software, provides a chat box that can be used to take notes. If someone runs to the bathroom, and you don’t want to forget your question, you can enter it in the chatbox. Chat boxes are especially helpful when there is a language barrier, or someone’s accent is hard to understand. Text typed in the chatbox also serves as a place to record information that may be difficult to remember if you cannot access your audit report. If a production area has too much background noise, the chat feature might be the best way to communicate important details, such as: “That information is found in section 7.5.6 of the Quality Manual; POL-001 rev A.” The chatbox can also be used to communicate a list of documents, or records in a specific date range, that you want an auditee to make available for you to review off-line. Other participants observing the audit may also be responsible for collecting those documents in real-time to ensure the audit can continue without any delay. Finally, content in the chatbox can be recorded as a text file automatically.
  • Tour Guide – Video chat allows auditees to bring auditors into physical places of their facility as if the auditor were there in person. Production employees can be interviewed, in person and in real-time, while the employee demonstrates processes. You can show how nonconforming materials are labeled and segregated to keep them from accidentally being used for production. When requesting this audit method in an audit agenda, the lead auditor should recommend a dedicated “camera person” with a mobile phone and selfie stick, because it is challenging to answer auditor questions and operate a video camera simultaneously. Remember, remote audit resources consist of hardware, software, and people

My favorite remote auditing tools (hardware)

My favorite hardware resource is the Pixelbook that I am using to write this article. We write audit reports with Google Docs instead of Microsoft Word because multiple team members can simultaneously edit the same document without creating conflicting versions. We operate Zoom video web conferencing software to speak with auditees and clients, but we use the Pixelbook to type our notes and audit reports. The Pixelbook is lightning fast, and it is a little smaller, so there is just enough room on your desk next to a laptop. The most significant advantage of using Google Docs is realized when you are the lead auditor of an audit team. As a lead auditor, you can type notes in the section of the audit report that other team members are working on, to make sure that they include audit trails from other members of the audit team. This is also an extremely useful technique when you are training a new auditor, and you want to guide them without disrupting the flow of an interview with a subject matter expert.

My second favorite hardware resource is an HD webcam mounted on a flexible arm with a clamp (see picture above). The video quality is 1080p instead of the 720p that is typical of a laptop camera. The flexible arm is equally essential because you can look directly at the camera while I’m simultaneously looking at the monitor. The only thing I dislike about the webcam I am using is the audio quality. Therefore, I use a gaming headset with a microphone to record the audio, so I can hear the people I am interviewing better. Another alternative is high-quality microphone and headphones, as typically seen in use by podcasters. Even though the sound quality is ideal with a separate microphone and headphones, the cost is higher than most gaming headsets, and you will be tethered to microphone–either physically or at least virtually by the need to maintain a consistent distance between your mouth and the microphone. The more hours you spend at the computer, the more you will appreciate the ability to stand up, adjust the camera, and move your legs a little.

Finally, the last piece of essential remote auditing hardware is your mobile phone. Even with a desktop running Zoom, and a Pixelbook running Google Docs, I still need to ask audit team members questions and conduct quick internet searches. Therefore, your mobile phone is essential to keep with you, in silent mode, during your audit. If you don’t have your phone, then you need to stop sharing your screen and send a message during your audit. Your phone is much less disruptive. I use the phone to keep track of time, to set reminder alarms, and to send Slack messages with other people. You can also join a separate Zoom session on your phone, where an audit team member may need you (the lead auditor) to provide input on objective evidence or evaluation of conformity regarding specific quality system requirements. You might also want to take a quick picture of something you observe on video during the audit. If you record the Zoom session, you can always extract a still image, but taking a picture with your mobile phone is more convenient and takes less time. You can then share the image with a Google Drive folder for your remote audit and copy the image into your audit report. As they say, a picture is worth 1,000 words.

One last note on hardware: a 48” flat screen is great for virtual bike rides on your trainer (as seen in the picture above), but it’s just a little too big for a desktop monitor. It’s excellent for side-by-side viewing, but dual monitors are a better approach.

Remote Auditing Resources for Web Conferencing

Currently, we are using Zoom as our video web conferencing software. Still, we used to use GoToMeeting, and there is very little difference in the functionality of the two software platforms. One of the consequences of the COVID19 pandemic is that everyone is more familiar with web conferencing software. Here are a few other options you could consider, including Slack, which we use as a messaging tool, and we have integrated with Zoom within our team’s channel.

  1. Google Meeting
  2. Skype
  3. Microsoft Teams
  4. Monday
  5. Slack

Remote Audit Resources for Scheduling Your Audit

Currently, we are using Calendly as the automated appointment scheduling software application for our consulting business. However, the functionality of software applications has changed dramatically in the past few years with better integration tools, such as Zappier.  Therefore, don’t be surprised if we change to one of the applications listed below. These applications allow you to manage people, equipment, and conference rooms, but you can also integrate these applications with accounting business processes.

  1. Simplybook.me 
  2. Acuity Scheduling 
  3. Jobber 
  4. Gigabook
  5. vcita

Remote Auditing Accessories

We hosted three international training workshops, and we record training videos for medical device companies every week. Therefore, we gradually accumulated all of the accessories listed below. Technology gadgets for recording videos are continually changing, and our best advice is to save your money. Instead, rely upon a mobile phone and an extra person with “the original selfie sticks” (i.e., arms). Once you complete your first remote audit, then you can think about which of the latest gadgets might make your life easier.

  • Selfie Sticks
  • Tripod
  • External microphones
  • Portable Batteries
  • Additional lighting

If you have any suggestions for additional hardware and software for remote auditing, please add a comment to this article so we can keep this up to date with the latest technology. 

Future Articles & Webinars

Thank you for reading. This article is our third in a ten-part blog series specific to remote auditing techniques:

  1. Remote audit opening meeting – 4 changes – May 12
  2. Audit team communications – May 19
  3. Remote audit resources – software and hardware tools – May 26
  4. How to apply a risk-based auditing approach to audits and remote audits – June 2
  5. How to make a supplier questionnaire for remote auditing – June 25
  6. Remote audit duration less than 90 minutes – June 30
  7. Remote auditing work instruction – July 14
  8. Planning partial remote audits – July 21
  9. Remote audit invitations – 4 things to remember – August 4
  10. Training new audit team members and lead auditors – August 11

Five (5) new webinars planned on related topics:

  1. Opening Meetings Webinar (free) – May 14, 2020
  2. Audit team communication during a remote audit (free) – June 4, 2020
  3. How to qualify your suppliers webinar (pre-order by June 1) – June 25, 2020
  4. Remote auditing techniques webinar (pre-order by July 1) – July 16, 2020
  5. MDSAP Certification Body Interviews (free) – August 6, 2020

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Audit team communication

The lack of visual cues may hinder communication between the auditor and the auditee, but software tools can enhance audit team communication.

Audit Team Communication Cup Phone Audit team communication

Audit Team Communication Requirements

During the opening meeting, the lead auditor is responsible for confirming the “formal communication channels between the audit team and the auditee…[and] the auditee being kept informed of audit progress during the audit” (ISO 19011:2018, Clause 6.4.3). Typically, the audit program manager will follow the lead auditor during the audit. In that situation, audit team communication with the auditee is direct and verbal. However, if the audit team consists of multiple auditors, the lead auditor also needs to establish a method of communication between the team members and the lead auditor. Team members need to make the lead auditor aware of any potential nonconformities, but more critical information includes:

  1. audit trails that require follow-up by auditors in other process areas
  2. any delay experienced by team members
  3. if an audit team member is ahead of schedule

Communication Limitations During On-Site Audits

During an on-site audit, it is not uncommon to have limited communication with the rest of the team, because the team is interviewing auditees and walking through the facility–not sitting at their computer. Sometimes your cellular signal is inadequate for texting or other messenger services such as Slack. It may also be more difficult to have private discussions between team members during an on-site audit. Usually, the audit schedule is very tight, and team discussions must wait until lunch breaks or scheduled team discussions. Unfortunately, these limitations frequently result in the follow-up of audit trails waiting until the very end of the audit, instead of addressing audit trails at more convenient times in the middle of the audit.

Communication Between Auditors During Remote Audits

During a remote audit, all of the audit team members will readily be able to exchange information by email, text, or Slack. Besides, applications like Google Docs allow multiple auditors to type in the same audit report simultaneously. Therefore, auditors can type a specific follow-up item in the section of the audit report, where another auditor will be typing their notes for the applicable audit area. For example, if one auditor is interviewing incoming inspection activities, they can type a note for the auditor that will be auditing calibration to review the calibration certificates for inspection devices used in the incoming inspection process. If an audit team leader needs more time, they can type a quick note for the lead auditor about the need for more time. The lead auditor can also quickly send a Slack message to the rest of the audit team, asking if anyone can aid the audit team member that is behind schedule. This communication is efficient, documented directly within the report, and occurs in real-time. The result is that communication between team members is more effective, and the audit is completed earlier.

Improvement of Auditor Training with Remote Auditing

When audit team members are being trained, the lead auditor must observe their auditing and provide constructive feedback. Ideally, the lead auditor will wait for a “teachable moment.” This is the moment immediately after the lead auditor-in-training makes a mistake. Telling an auditor-in-training what to do during an audit teaches the auditor little. However, if the auditor is allowed to make a mistake, such as forgetting to ask for an audit record, then the lead auditor can point out the error immediately afterward. Correcting the auditor can be as simple as adding a note in red font within the audit report in the same section where the auditor is currently typing. The auditor will see the comment and make the correction, but the auditee will not be aware of the error. This approach avoids any embarrassment to the auditor, and the auditor is more likely to remember the instruction as constructive feedback that will make them better.

Remote Auditing Can Be Easily Recorded

Auditors can learn from the constructive feedback provided by a lead auditor, but they can also learn by watching and listening to themselves if the remote audit is recorded. This is especially easy to accomplish for internal audits, but suppliers may also allow recording of certain process audits. Opening meetings, closing meetings, and common procedures such as incoming inspection usually do not include confidential information. Therefore, you should be able to obtain permission to record these portions of the audit. These recordings can be reviewed by the auditor to identify when poorly worded questions were used. Auditors-in-training can identify when they miss an opportunity to follow an audit trail, or an auditor may realize that they ask auditees certain closed-ended (i.e., yes/no) questions instead of open-ended questions that will help them gather more information from the auditee.

Audit Team Communication with Guides

In addition to the communication between the lead auditor and the audit team members, audit team members also need to communicate with their audit guides. Guides should be used to communicate messages throughout the company. For example, if the audit is behind or ahead of schedule, the guide can communicate adjustments in the timing of the agenda. If an audit team member requests records to be provided, the guide can communicate this request and make sure the records are waiting for the auditor when they return to the audit conference room. Guides also are responsible for helping the audit team navigate from one process area to another during the audit, and to make sure that the audit team observes all safety and gowning requirements during the audit. Finally, guides may also be asked to act as an observer and verify objective evidence collected by the auditor.

Shifting Role of a Guide During Remote Audits

During a remote audit, requests for records to be provided and communication of deviations from the agenda can easily be communicated by the auditor chat features in the video conference, instant messengers, or email. Therefore, you might think that a guide is unneeded. However, when audit team members request viewing another area of a facility during a remote audit, it may be necessary to provide live video images of the process areas. It isn’t easy to speak with the auditor and provide live video images. It may be dangerous to walk backward through your facility, carrying a selfie stick, and concentrating on your discussion with the auditor instead of where you are walking. Instead, the guide should focus on providing live video, and the process owner should be concentrating on providing a guided tour and answering the auditor’s questions. The guide may also be asked to record certain information in video or picture format as objective evidence.

Conclusion

Audit teams should practice using shared documents in Google Docs and Slack during the audit to facilitate real-time audit team communication. Google Docs enables everyone to write their audit notes directly into an audit report template to eliminate delays in the completion of the audit report. Using Google Docs also makes it possible for the lead auditor to observe the progress of the audit in real-time. Audit team communications of audit trails for team members to follow-up can be accomplished in real-time by just adding a note about the trail in the applicable section of the audit report. Finally, remote auditing can facilitate better training of auditors.

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