How to implement a new ISO 13485 quality system plan in 2016

3 Comments / ISO Certification / By Robert Packard

This article is a case study that explains how to implement a new ISO 13485 quality system plan at an accelerated schedule of just four months. The quality system will also be compliant with 21 CFR 820.

ISO 13485 quality system plan

Typically, I recommend implementing a new ISO 13485 quality system plan over a period of 6 months. The reason for this is that people can only read procedures and complete training at an individual pace. Since there are approximately 30 procedures required for a full-quality system, an implementation pace of one procedure per week allows a company to complete 90% of the reading and training in six months.

In October, a new client asked me for a proposal to implement a new ISO 13485 quality system plan. The proposed quality system plan indicated that the project would start in October and finish in March. The client accepted my proposal, but they asked me to help them implement the quality system plan in four months, as indicated in the table above. We just started the implementation of the quality system plan last week, and I have discovered some secrets that dramatically simplify the process. This blog shares some of the lessons learned that help implement the quality system plan at this faster pace.

Outsourcing ISO 13485 quality system development

Not everyone has the skill and experience to write a quality system procedure. Still, if you have a good template, you understand quality systems–then you can write quality system procedures. Depending upon the length of the procedure, it may take four to eight hours of writing for each procedure. Therefore, an in-house quality manager needs to allocate one day per week if they plan to write all the procedures for their quality system in six months. For a four-month implementation of an ISO 13485 quality system plan, you need to allocate two days per week to writing.

Alternatively, you can outsource the writing of your quality system. However, someone must be responsible for “customizing” generic procedures to fit your company, or the procedures need to be written from scratch. A third and final option is to have a hybrid of in-house procedures and outsourced procedures. If your quality manager has limited time resources, then you can supplement the managers’ time with procedures that are purchased and customized to fit your template. If there are specific procedures that the quality manager needs help with, such as risk management, then you can also purchase just those procedures.

Continuous Improvement

One of the basic principles of quality management systems is “continuous improvement.” The continuous improvement cycle is also known as the “Deming Cycle.” There are four parts to the cycle:

Plan
Do
Check
Act

When you are developing an ISO 13485 quality system, the first step is to develop the quality system plan. I recommend the following guidelines for a quality system plan. First, plan to implement the quality system at a steady pace. Second, organize the implementation into small groups of related procedures.

In this case study, I have 29 procedures that we are implementing, and there are 11 recorded training webinars. During each of the four months, approximately the same number of procedures are implemented. Then I organized the small groups of procedures around the scheduled webinar training. For example, the month of November will have a total of 24 documents (i.e., eight procedures and 16 associated forms and lists) implemented, and there are four webinar trainings scheduled. Therefore, four procedures related to “Good Documentation Practices 101“ will be implemented as a group under document change notice (DCN) 15-001. Two procedures associated with “Are your Suppliers Qualified? Prove it!“ will be implemented as a group under DCN 15-002. The remaining two procedures, design controls, and risk management, will be implemented as a group under DCN 15-003 with two related webinars on design controls and ISO 14971.

Document Change Notice (DCN)

The next step in the Deming Cycle is to “Do.” For the implementation of an ISO 13485 quality system plan, “doing” involves the creation of procedures, forms, and lists, but “doing” also involves the review and approval of these documents. The form we use to review and approve procedures is called a document change notice or DCN.

It’s been almost 20 years since I completed my first DCN. For anyone unfamiliar with the review and approval of new and revised documents, most quality systems document the review and approval of procedures and forms on a separate form. The reason for this is that when you make one change, it often affects several other documents and forms. Therefore, it is more efficient to list all the documents and forms that are affected by the change on one form. This results in fewer signatures for reviewers and approvers. Several of the companies that I have helped to implement an ISO 13485 quality system plan for failure to review and approve the documents and forms in a timely manner. I think there are two reasons for this:

they haven’t been responsible for document control before, and
they don’t want to have to create and maintain quality system records any sooner than required.

The first reason can be addressed quickly with training. The second reason, however, is flawed. It is essential to implement the procedures as soon as possible to begin creating quality system records that can be audited by an ISO 13485 certification auditor or by FDA inspectors for compliance with 21 CFR 820. I have struggled with this hesitation in the past, but for this project, I am completing DCNs for the initial release of all the procedures and forms. This ensures that all the procedures and forms will be reviewed and approved shortly after the webinar training is completed. Also, this gives my client multiple examples of DCNs to follow as they make revisions to the procedures and forms over time.

Quality Objectives & Data Analysis

The third step in the Deming Cycle is to “check.” I recommend using quantitative metrics to track progress toward your goal of completing the quality system implementation. For example, if you have 50 documents to review and approve, you can track the % complete by just multiplying each document that is approved by 2%. You can also track the implementation of documents separately by type. Every DCN you route for approval will take a certain number of days to complete. You might consider tracking the duration of DCN approval. As a benchmark, an efficient paper-based DCN process should average about four days from initiation to completion. I have seen average durations measured in months, but hopefully, your average duration of DCN approval will be measured in days. Another metric to consider is the % of required training that has been completed for the company, for each department, and for each employee. Regardless of which metrics you choose to evaluate your quality system implementation, you should pick some of these metrics as quality objectives (i.e., a requirement of ISO 13485, Clause 5.4.1). You should also analyze this data for positive and negative trends as required by ISO 13485, Clause 8.4.

Your first CAPAs

The fourth and final step in the Deming Cycle is to “act.” Acting involves taking corrective action(s) when your data analysis identifies processes that are not functioning as well as they should be. To achieve ISO 13485 certification, you will need some examples of corrective and preventive actions (CAPAs) that you have implemented. The steps you take in response to observed trends during data analysis are all potential CAPAs.

Download an ISO 13485 quality system plan

Later this week, I will be posting a follow-up blog that explains how to write an ISO 13485 quality system plan for establishing a new quality system. There will also be a link for downloading a free ISO 13485 quality system plan.

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Feb 19 2015

Good Documentation Practices (GDP 101) Webinar

Leave a Comment / ISO Certification / By Robert Packard

Medical Device Academy released a new webinar this week for training companies on good documentation practices.

Have you ever wondered where the FDA regulation is that says, “…shall not use white-out to correct quality system records.”

Don’t bother looking, because you won’t find it. You also won’t find any regulations against the use of red pens, highlighters, pencils, or markers. You can’t even find a guidance document that tells you not to put a single line through mistakes, initial and date it.

The applicable regulation is 21 CFR 820.180, but the regulation doesn’t specifically say these things. Instead, the regulation states: “Records shall be legible and shall be stored to minimize deterioration and to prevent loss.” The ISO 13485 Standard is not much different. It states that you must establish a procedure that will “Define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.”

Over time medical device companies have developed some standard approaches to meet the requirements for Document Control, Control of Records, and Training. These are the three core processes that I call “good documentation practices.” If you need training or you need tools for training employees, click on the link below to purchase our new webinar on good documentation practices.

http://robertpackard.wpengine.com/good-documentation-practices-webinar/

The webpage also includes an exam for training people on good documentation practices. The exam serves as a useful check for the training, but we recommend that process owners monitor these processes–especially if the process is manual. For example, QC inspectors will complete inspection records and file the record as a quality system record. The QC supervisor, or process owner, should periodically review these records for completeness and accuracy. If the supervisor notices an error, the supervisor should notify the inspector and have them correct the mistake. The supervisor should also track how many times each error is made and specifically where errors are occurring. The collection of this data gives the supervisor trend data to help them identify which forms need to be updated to prevent mistakes and which employees require retraining. This data also provides evidence of competency for each employee concerning good documentation practices.

After you have completed the training, you might also be interested in downloading our procedures for Document Control, Control of Records and Training:

http://robertpackard.wpengine.com/standard-operating-procedures-medical-device-academy/

Good Documentation Practices (GDP 101) Webinar Read More »

Dec 9 2014

How to reconcile the conflict between ISO 13485 and ISO 9001

3 Comments / ISO 13485:2016, ISO 9001:2015, ISO Certification / By Robert Packard / ISO 13485, ISO 13485 standard, ISO 9001, ISO 9001 standard, upcoming ISO 13485 and 9001 standards

This blog explains how to reconcile the conflict between ISO 13485 and ISO 9001, and discusses whether you should maintain dual certification.

What is the conflict between ISO 13485 and ISO 9001?

The previous version of ISO 13485 was released in 2003. That standard was written following the same format and structure as the overall quality system standard at the time (i.e., ISO 9001:2000). In 2008, there was an update to the ISO 9001 standard, but the changes were minor, only clarified a few points, and the periodic review of ISO 13485 in 2008 determined there was not a need to update 13485 at that time. Unfortunately, the proposed structure of the ISO 9001 standard was radically different, and this forces companies with dual certification to reconcile the conflict between ISO 13485 and ISO 9001.

On December 1-5, 2014, the working group for the revision of ISO 13485 (i.e., TC 210 WG1), met at AAMI’s Standards week to review the comments and prepare a first Draft International Standard (DIS). We should have some updates on the progress of the DIS later in December, but hopefully, the news will not be delayed in publication until 2016. The following is a summary of the status before last that meeting.

Updated ISO 13485 and ISO 9001 Standards Being Released

In 2015, there will be a new international version of ISO 9001 released. This new version will have dramatic changes to the standard–including the addition of a new section on risk management and the adoption of the new High-Level Structure (HLS) changing from 9 sections to 11. The ISO 13485 standard is also anticipated to have a new international version released in 2015, but the ISO 13485 standard will maintain the current HLS with nine sections. The timing of the ISO 9001:2015 release and the ISO 13485:2015 release will likely be around the same time (Correction: the ISO 13485:2016 standard was released in February 2016). Both standards are expected to have a three-year transition period for implementation. The combination of the three-year transition and lessened requirements in the new version of ISO 9001 for a structured quality manual should allow most manufacturers to wait until the ISO 13485 release before they begin drafting a quality plan for compliance with the new standards. Some of my clients have already indicated that they may drop their ISO 9001 certification when it expires, instead of changing their quality system to comply with the ISO 9001:2015 requirements. However, my clients will not have the ability to allow their ISO 13485 certification to lapse. Will Health Canada be updating GD210 and continue to require ISO 13485 certification for medical device licensing? What should companies do?

Update on the reconciliation of ISO 13485:2016 and ISO 9001:2015 on May 29, 2020:

GD210 was never updated, and instead, it was replaced by MDSAP
ISO 13485:2016 certification, under the MDSAP program, is required for Canadian Medical Device Licensing
Many device companies have dropped the ISO 9001 certification.

Recommendations

From the experience of preparing for the ISO 13485:2016 and ISO 9001:2015 releases, I learned that obtaining draft versions of the standards before publication is invaluable. I was able to use the drafts to help prepare quality plans for the transition. Second, companies need to train their management teams and auditors on the differences between the current and the new standards to enable a gap analysis to be completed. Any manager that is responsible for a procedure required by the current version of a standard should receive training specific to the changes to understand how they will meet the requirements for documented information. Most companies will need to improve their risk management competency (which was updated again in December 2019). I recommend that companies begin drafting their quality plans and enter discussions with their certification body for quality system changes as early as possible. I also recommend that medical device companies maintain a quality manual structure that follows the ISO 13485:2016 standard rather than the ISO 9001:2015 standard. Following ISO 13485:2016 will help everyone locate information faster.

There is also specific text in the introduction of ISO 9001:2015 that states it is not the intent of the standard to imply the need to align your quality management system to the clause structure of the standard. Companies that maintain ISO 9001 certification should consider including cross-references between the two standards in their quality manual.

Historical Note

There are also European National (EN) versions of each standard (e.g., EN ISO 13485:2012). The EN versions are harmonized with the EU directives, but the content of the body or normative sections of the standards are identical. Historically, the differences were explained in Annex ZA, which was the last Annex in the EN version of the standard. In 2009 the harmonization annex for ISO 14971 (i.e., the medical device risk management standard) was split into three parts to match up with the three directives for medical devices (i.e., the MDD, AIMD, and IVDD). The new annexes (i.e., ZA, ZB, and ZC) were moved to the front of the EN version of the standard. The changes to ISO 14971 consisted of a correction and the change to Annex ZA. In 2012, there were new harmonization annexes created for ISO 13485 to follow the same format that was used for the EN ISO 14971 annexes. It is expected that these “zed” annexes will be released with a new EN version of the standard shortly after the international standard is published.

How to reconcile the conflict between ISO 13485 and ISO 9001 Read More »

Aug 26 2014

Nonconforming Materials Disposition

4 Comments / ISO Certification / By Robert Packard / 21 CFR 820.90, 21 CFR 820.90 compliance, disposition of nonconforming materials, medical device nonconforming materials, nonconforming material, nonconforming materials

Nonconforming materials disposition can be simplified into four categories: scrap, return to supplier, rework, and use as is.

Nonconforming materials disposition

In our previous blog, we focused on requirements to identify and segregate non-conforming materials. Once nonconformities are labeled and locked in your quarantine cage, what do you do next? The next step in the process of determining nonconforming materials disposition. The most common dispositions are:

Scrap
Return to Supplier (RTS)
Rework
Use As Is (UAI)

Some companies also have dispositions of sort and repair. The sort is not a disposition and often creates confusion for anyone auditing records of nonconforming materials. Sorting is the process that you must perform when a lot of material fails to meet acceptance criteria. Still, some of the individual units within the lot meet the acceptance criteria. In this scenario, the following sequence of events is recommended.

Sorting nonconforming materials

First, the lot is segregated from a conforming product, and an NCR number is assigned. Next, the lot is 100% inspected for the defect, and the results of the inspection are recorded on the inspection record. It is important to record the specific number of non-conforming units on the NCR record–not the total amount inspected. The final step is to release a conforming product back into the production process or warehouse, and the Material Review Board (MRB) will disposition the units identified as non-conforming.

If identifying a non-conforming product requires an inspection method that is not typically performed, then the inspection plan needs to be corrected, or a corrective action plan is needed. New and unforeseen defects may indicate a process change, a change in the raw materials, or inadequate training of personnel at your company or your supplier. An investigation of the root cause is needed, and it is recommended to consider documenting this investigation as an internal CAPA or a Supplier Corrective Action Request (SCAR).

Material Review Board (MRB) determines the nonconforming materials disposition

Most companies have a “Material Review Board” (MRB) that is responsible for making the decision related to the disposition of non-conforming material. Typically, the MRB will be scheduled once per week to review the most recent nonconformities. The board usually consists of a cross-functional team, such as:

Quality Assurance
Research & Development
Manufacturing
Supply Chain
Regulatory

The reason for a cross-functional team is to review the potential adverse effects of rework and potential risks associated with a UAI disposition. If rework is required, the cross-functional team will typically have the necessary expertise to create a rework instruction and to review and approve that rework instruction–including any additional inspections that may be required beyond the standard inspection work instructions.

Scrap

If the material is going to be scrapped, there is no risk to patients or users. Therefore, the entire MRB team should not be required to scrap products. Because there may be a cost associated with a scrap of non-conforming products, it is recommended that someone from accounting and a quality assurance representative approve scrap dispositions. Other departments should be notified of scrap, but a trend analysis of all non-conforming products should be reviewed by each department and by top management during management reviews. Auditors and FDA inspectors, specifically, will be looking for evidence of statistical analysis of non-conforming material trends and the implementation of appropriate corrective actions.

Return to Supplier (RTS)

Returning non-conforming material to the supplier that produced it is the most common disposition, but the trend of RTS should continuously be improving. If the trend of RTS is not improving, your supplier qualification process or your supplier control may be inadequate. The best way to ensure that the trend is improving is to initiate a SCAR. Some companies automatically wait until they have a trend of non-conforming material before initiating a SCAR. However, if you wait until a defect occurs twice, you are doubling the number of nonconformities for that root cause. If you wait until a defect occurs three times, you are tripling the non-conformities. For this disposition, there also does not need to be approval from the entire MRB. Typically, only someone from the supply chain management and quality assurance are needed to return non-conforming products to a supplier.

Note: You should not always wait until there is a “trend” to request supplier corrective action.

Rework

Almost every auditor looks for a specific phrase in the procedure for Control of Nonconforming Material: “The MRB will review and document the potential adverse effects of rework.” Most companies are doing this, but the procedures often do not specifically state this requirement, and rework instructions are often missing any specific inspection instructions that have been added to reduce risks associated with the rework process. Repeating the normal inspection criteria is seldom adequate for reworked product because the rework process typically results in different defects.

Another phrase that auditors and inspectors are looking for is the requirement to document the rework instructions and to have the instructions reviewed and approved by the same functions that reviewed and approved the normal production process. This requirement is often not specifically stated in the procedure, and FDA 483 inspection observations are commonly issued for this oversight.

Use As Is (UAI)

The UAI disposition should be rare. When I see a large number of NCRs with a disposition of UAI, I expect one of two reasons for this situation. First, the NCRs are for cosmetic defects where the acceptance criteria are too subjective and inspectors need clear guidelines regarding acceptable blemishes and unacceptable nonconformities. The visual inspection guides used during solder joint inspection for printed circuit boards are an excellent example of best practices for clearly defining visual inspection criteria. Personally, I prefer to use a digital camera to take pictures of representative “good” and “bad” parts. Then I create a visual inspection chart with a green, smiley face for “good” and a red, frowny face for “bad.” The best inspection charts identify the proper inspection equipment and quantitative acceptance criteria with pictures and symbols instead of words.

The second reason for a larger percentage of UAI dispositions is that the product specifications exceed the design inputs. For example, if a threaded rod needs to be at least 1” long, but 1.25” long is acceptable, then you should not approve a drawing with a specification of 1.00” +/- 0.05”. Often, the legend of drawings will define a default tolerance that is unnecessary. A more appropriate specification would be 1.13” +/- 0.12”. No matter how much work it is to specifically define tolerances for each dimension on a drawing, the work required to do this at the time of initial drawing approval is much less than the work required to justify a UAI disposition. FDA inspectors will consider a UAI disposition as a potentially adulterated or misbranded product, and a formal Health Hazard Evaluation (HHE) may be required to justify the reason why the product is not recalled.

Regardless of the disposition of the product, the decision for disposition should be a streamlined process that is not delayed unnecessarily. In order to ensure that your non-conforming material dispositions are effective and processed in a timely manner, our next blog in the series about control of non-conforming materials will focus on process interactions, monitoring and measuring of non-conforming product and when to initiate a CAPA or SCAR to prevent more NCRs.

Nonconforming Materials Disposition Read More »

Mar 26 2014

Stage 2 audit preparation for ISO 13485 certification – Part 2

1 Comment / ISO Certification / By Robert Packard / how to prepare for an ISO 13485 certification stage 2 audit-part 2, ISO 13485 certification, ISO 13485 certification stage 2 audit

In this article, you will learn what ISO 13485 stage 2 audit preparation you should complete specific to training records and practice interviews.
Stage 2 Audit Preparation

If you aren’t sure what ISO 13485 is, please visit our two-part training webinar series. During your Stage 1 ISO 13485 Certification audit, the auditor verifies that your company has all 28 procedures required in ISO 13485:2016. During the Stage 2 audit preparation, however, the auditor will be reviewing training records for each employee. A training matrix is one of the best tools for verifying that your training records are completed. First, you create a table of all 28 required procedures in Excel (this is your far left column). Across the top of the table, you need to list each of the employees in your organization. This would be difficult for a large organization, but most companies seeking initial ISO 13485 certification have less than 20 employees. In your training matrix, you need to identify which procedures each employee must be trained on. This is one of the most common ways to identify training requirements, and color-coding the matrix works is helpful.

Once you have defined your training requirements, review and approve this document as a controlled document that you will maintain as the company grows. However, as the company grows, you may convert specific names to job functions. Once the training requirements matrix is reviewed and approved, you should enter the date that training was completed for each employee. This is a more effective check than the “checkbox” approach, and it enables you to verify that everyone was trained since the last revision of any procedure. Now, you have a summary document to prove that 100% of your employees have current training on each of the 28 required procedures.

Interview employees as part of your Stage 2 audit preparation

During the Stage 2 audit, any of the employees could be interviewed by the auditor. As part of your Stage 2 audit preparation, you should interview each employee on your training matrix by asking them the following open-ended questions:

Can you show me where I can find the company’s quality policy?
Please explain how the quality policy is relevant to your job.
Can you show me a copy of the training procedure?
What quality objectives do you or your department monitor?

The first question is typical of auditors. You don’t have to have the policy memorized, but every employee should know where to find it. My favorite location is the back of employee ID badges, but the quality policy needs to be updated periodically. If everyone has the policy on their ID badge, you might consider handing out updated stickers with the revised quality policy when you hand out paychecks. The second question is related to the first, and it verifies that each person understands the importance of their job function as it relates to quality.

The third question is a test to ensure every employee can locate procedures. Don’t help them, because the auditor won’t. After each employee answers the question, make sure you explain the correct answer concerning where the most current version of every procedure is. Redlined copies in a drawer do not exist. The person should also have read each procedure in their training matrix so that they can answer a question. It’s ok to say “I don’t remember,” but they shouldn’t guess.

The fourth question verifies that top management has established quality objectives for all functions and at all levels within the company. Every manager should have at least one quality objective they are tracking, and progress toward the quality objective should be visibly communicated to everyone in the department. Employees, especially managers, should also be aware of where quality objectives for the company as a whole are posted. Ideally, each employee will know how their job function contributes to one or more of these objectives.

Stage 2 audit preparation – How to handle “stage fright”

Anyone can get nervous when they are being interviewed by an auditor–even the most experienced managers. In particular, a large entourage of observers following an auditor can make the situation worse. Therefore, you should anticipate this and discuss this with every employee in your company when you are doing practice interviews. Tell them this is normal, and it’s ok to be nervous. Remind them to take a deep breath to settle their nerves. Assure employees that they will not get in trouble for being nervous, and the company will not fail and audit just because someone has difficulty answering a question. At worst, you will need to initiate a CAPA and do some more training. The best-case scenario for a certification audit is that you will need to initiate a CAPA and do some more training. Either way, the outcome is the same.

Congratulations on your successful Stage 2 audit preparation

Do not stress everyone out the day before your Stage 2 certification audit. You had six months to prepare, and everyone worked hard to help prepare the company. Now is the time to celebrate with your family. Everyone should go home on time and get a good night’s rest. Positive attitudes and relaxation are as crucial as all the work that has been completed. I learned this lesson the hard way during my first ISO 13485 Certification in 2004. We received certification, but I don’t recommend letting your boss turn purple with rage during the audit–it might be career-limiting.

I have only made the mistake of staying up late the night before on one other occasion–and the client was not recommended for certification at the end of the Stage 2 audit. Fortunately, the auditor was able to schedule a follow-up audit within a few weeks, and we were able to address all the open issues at that time. The client received their ISO 13485 certificate and CE Certificate within three months of starting the project, and the certificates were just in time for an important trade show in Germany.

Additional training resources to prepare for ISO 13485:2016 certification

If you are interested in learning more about ISO Certification, please download Medical Device Academy’s whitepaper and watch our six-part webinar training certification course for ISO 13485:2016 certification preparation.

Stage 2 audit preparation for ISO 13485 certification – Part 2 Read More »

Mar 20 2014

Stage 2 Audit – How to Prepare (Part 1 of 2)

1 Comment / ISO Certification / By Robert Packard / how to prepare for an ISO 13485 certification stage 2 audit, ISO 13485 certification, medical device regulatory compliance, Stage 2 audit

This blog teaches you how to prepare for a stage 2 audit on your pathway to ISO 13485 certification, and this blog is part 1 of 2.

Stage 2 Audit

If you are not sure what ISO 13485 is, please consider our 2-part training webinar on the topic. Health Canada requires ISO 13485 certification as a requirement for all Medical Device License Applications, and most companies choose ISO 13485 certification as their method for demonstrating conformity to the requirements of the European Medical Device Regulations (MDR)–instead of a special MDD audit.

To achieve ISO 13485 certification, you must successfully complete a Stage 1 and Stage 2 certification audit with your chosen certification body. If you are interested in an overview of this certification process, you can download Medical Device Academy’s white paper on this topic, or you can watch a webinar we recorded recently on 6 steps to ISO 13485 Certification.

Management Processes are covered during the Stage 1 and Stage 2 audit

The Stage 1 audit is typically a one-day audit where the auditor is evaluating your readiness for the Stage 2 audit. The auditor will review your Quality Manual, and your procedures (19 are required) to ensure compliance with ISO 13485. Also, the auditor will sample records from critical processes to assess your readiness for the Stage 2 audit. Typically, these processes will be:

Management Review
CAPA
Internal Auditing

After you complete the Stage 1 audit, you may have a few nonconformities identified by the auditor. Responding to these nonconformities is the first step in preparing for your Stage 2 certification audit. You need to initiate a CAPA for each of the auditor’s findings and begin implementation before the Stage 2 audit. Typically, you will have about six weeks to implement these actions. This is not usually enough time to complete your CAPAs because you need more time before you can verify the effectiveness of corrective actions.

Preparing CAPA Records is critical for your Stage 2 audit

In preparation for your Stage 2 audit, prepare for the auditor to review any CAPAs that you completed since the Stage 1 audit–especially if you have evidence of completing an effectiveness check. You may think this is unnecessary because the auditor previously reviewed CAPAs during Stage 1. However, you probably received a nonconformity related to your CAPA process (almost everyone does), and you should expect auditors to review your CAPA process during every audit.

Each CAPA record you present should be provided in a separate folder as a paper, hardcopy. The paper, hardcopy makes it easier for the auditor to review. The folder should include documentation of the investigation, a concise statement of the root cause, and copies of records for all corrections and corrective actions implemented. Corrective actions include procedure revisions and training records. If there is a quantitative measurement of effectiveness, include a graph of current progress with the record. Ideally, the graph will be one of your quality objectives. The graph to the right is an example.

Production Process Controls will get the auditor out of the conference room

Every company has at least some production and process controls implemented before the Stage 2 certification audit. Most auditors and inspectors spend too much time in conference rooms reviewing paperwork and too little time interviewing people that are performing work. However, many companies also outsource production activities. Therefore, unless you have a software product, you can expect your auditor to review incoming inspection activities. The auditor is also likely to review the finished device inspection, storage, and distribution. If the auditor is thorough, they will also follow the trail from inspection activities to calibration activities, nonconforming materials, and data analysis.

Design Controls

If your company is a contract manufacturer, then you probably are excluding design controls (ISO 13485, Section 7.3) from the scope of your Quality System. However, if you are a manufacturer that performs design and development, then it is an element of the quality system that warrants special attention. During the Stage 1 certification audit, the auditor reviewed only your Design Control procedure. During Stage 2, the auditor will look for evidence of implementing design controls. Therefore, even if your company has not completed your first design project, the auditor will still want to see some evidence of implementation. The auditor will expect at least one design plan to be written, and at least one design review should be completed.

If you are familiar with the FDA Quality System Inspection Technique (QSIT) process for inspection, you might have noticed that this blog is divided into the same subsections identified in the QSIT Manual.

Stage 2 Audit – How to Prepare (Part 1 of 2) Read More »

Oct 28 2013

Effective training – six steps to teach QMS procedures

1 Comment / ISO Certification / By Robert Packard / Medical Device, medical device QMS procedures, medical device QMS procedures training, medical device quality training

Six steps to conducting effective training on medical device QMS procedures, including questions to ask for building consistent procedures.

Effective Training on QMS Procedures

There are six steps to conducting effective training on medical device QMS procedures, including questions to ask for building consistent procedures.

Your Quality Management System (QMS) needs to provide objective evidence (i.e., records) that your staff is trained on the procedures they use and that their training was effective. You must also establish documented requirements for competency. The following examples might help:

A record of you attending a course is a training record.
A record of your taking and passing an exam related to that course is a record of training effectiveness.
A record of you performing a procedure, witnessed by the trainer, is a record of competency. Your resume can also be a record of competency.

Unless a change is trivial in nature, signing a piece of paper that states you read and understood a procedure does not demonstrate training effectiveness. Learning and training are active processes that require engagement and interaction.

In a previous blog, I described a slightly different procedure structure with some extra sections. There are a number of benefits to that structure, one of which is that the structure facilitates training. The additional sections are referred to in this blog. Whatever template you use, consistency of structure, and presentation across your procedures makes the procedures easier to learn and increases usability.

6 Points to Consider for Effective Training on Medical Device QMS Procedures

Training requirements. For a new procedure, decide early in your writing which roles require training, what content is needed, and to what level is competency necessary. The example below is a table from a Quality Auditing procedure. The table shows the different requirements for different roles. I prefer to put this information in the procedure document—where it is unlikely to be overlooked or forgotten.
Open book? For each of the roles listed above, determine whether you need trainees to be able to follow the procedure without the document at hand, or to know the procedure, and be able to find what they need.
Training method. One-on-one or group? Classroom style, on-job, or remote? This depends on your company, the nature of the procedure, and your requirements above.
PowerPoint or not? My preference is to walk trainees through the procedure, actually, have them flip the pages and write notes on it. If I use PowerPoint, it’s to clarify the structure and emphasize important points.
Control of training copies. Paper copies of procedures and forms used for training should be controlled. Your Document Control procedure should allow for clearly marked “Training” copies to be available before the effective date. Make sure your training also reminds trainees where to find the officially released copy of procedures after training is completed.
Control of training material. Include your slides, training scenarios, quizzes, etc. in your document control system. Review and revise them each time you change a procedure.

Building Consistent Procedures: Questions to Ask and Recommendations

Use a consistent structure for your procedures, then build a consistent training structure around that. The predictability in structure will improve the effectiveness of your training.

Purpose. Why are we doing this? What is the outcome we are after?
Scope. When do I use this procedure? When do I not, and what do I do as an alternative?
References. How does this interface with other procedures? Turtle diagrams or interface maps are useful here
Definitions. Unfamiliar jargon, and terms that are used in a very specific way in this procedure
Risk. What risks does this procedure address? How does this affect the design of the procedure – why are we doing it that way? Refer to our earlier blog where we explain how to include this in each procedure
The procedure. Walkthrough the flowchart, explain the accompanying notes, and relate the procedure flow to the responsibilities and authorities outlined earlier in the procedure
Records. What do I do with the completed records from this procedure? Where do I find a copy when I need it?
Examples. I suggest a training version of the form (which should be available later for reference) with guidance and examples
Practice. Provide a scenario and a blank form for trainees to work through, individually or in groups
Testing. Check that the training has been effective. The role competencies that were defined earlier are the basis for the effectiveness criteria for a procedure. This training module may be enough to achieve that level, or a broader training program may be required to ensure operational-level competence. See our blog on training exams for more advice on testing.

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Oct 21 2013

Quality Management System Training Presentations and Exams

3 Comments / ISO Certification / By Robert Packard / medical device QMS, medical device QMS training, medical device quality management systems, medical device quality management systems training, QMS training, Quality Management Systems

Methods for developing a quality management system training presentation and exam to demonstrate training effectiveness for QMS procedures.

Quality Management System Training

Training records are a basic expectation for any quality system (i.e., Clause 6.2.2 of ISO 13485), but demonstrating effectiveness (Sub-Clause 6.2.2c) and competency (Sub-Clause 6.2.2a) is also required. Verifying training competency will be the subject of a future blog, but this blog focuses on the most common method for demonstrating training effectiveness—an exam.

Resource Needs

The challenge with creating a training exam is that it takes a serious time commitment to create a training presentation, to write an exam, to grade the exam each time an employee is trained, and issue training certificates. Each time you revise the procedure, you need to decide if retraining is required and how you will verify the effectiveness of training on the revised procedure. Finally, you need qualified trainers with appropriate documentation of their competency.

The larger your company is, the more value you will realize from creating training exams. Unfortunately, larger companies usually have more procedures too. It typically takes me 2-4 hours to develop a new training presentation for a process or procedure. I am currently developing training presentations for a small drug/device company that will have approximately 30 procedures. Therefore, it could take 60-80 hours to create training presentations for all the procedures.

Quality Management System Training Presentation Content

We have developed training courses for critical processes, such as CAPA, internal auditing, and design controls. Medical Device Academy will also be offering a free webinar in November on the topic of conducting more effective Management Review meetings. For other processes, such as calibration, we recommend the following step-by-step approach:

Overview slide of requirements
A slide for each sub-clause
An example of how the procedure is applied
An overview of the procedures’ key points

Our calibration procedure required a total of 11 slides—including a title slide and a slide for contact information. We also included a cross-reference to the applicable section of the procedure for each sub-clause of the ISO 13485 Standard (i.e., 7.6a, 7.6b, etc.). A balance used to weigh components was the training example, and there was a slide that explained essential considerations that can affect the accuracy of a balance.

During the process of creating the training presentation, we noticed that one of the sub-clauses of ISO 13485, 7.6, was not addressed by the procedure. Therefore, our systematic approach simplified the creation of a training presentation, and the strategy helped to identify a non-conformity in the procedure before it was released.

Exam Content

Verifying effective training is easiest with the use of quizzes or exams to test what the person learned. For training exams, we try to ensure that exam questions are objective and easy to grade. Therefore, most exams are ten questions. Questions are typically the fill-in-the-blank type of questions or multiple-choice questions. “Trick questions” are not recommended, but we do recommend using questions that force the trainee to look up the answers. This will force the trainee to become more familiar with the procedure.

For our calibration training exam, we could easily have one question corresponding to each slide, but not every sub-clause requirement is equally important. Therefore, we always try to include a question related to the most common things auditors and FDA inspectors will be looking for.

The calibration process includes a requirement to assess the impact on a product if a measurement device used for inspections is found to be Out-Of-Tolerance (OOT). Is there a need to retest or even recall products?

Almost every auditor I meet asks the above question during an audit, and most will even request records of calibrated devices that were found OOT.

Grading & Certificates

We typically use 70% as the criteria for passing an exam. The exams are protected forms with spaces to fill in and checkboxes. There are also spaces for the trainee’s name, title, and date of the training. Exams are emailed to the instructor, and the instructor will unprotect the document. The correct answers are indicated by highlighting the choice in green. Incorrect answers are indicated by highlighting the choice in red. Explanations for why an answer is incorrect are added after the question and highlighted in yellow. The graded exam is then emailed back to the trainee—along with a training certificate similar to the one shown at the beginning of this blog.

Retraining

In one of our blog posts, we recommended including a section on training and retraining requirements in each procedure. The challenge with revised procedures is that retraining is not always required. If retraining is needed, we recommend the following approach:

Create a separate retraining exam
Include a question(s) specific to the procedural revisions
Include a question(s) specific to recent nonconformities in the process (if any)

If you are interested in learning more about procedures, records, and training as it relates to ISO 13485 Certification, please consider our ISO 13485 webinar training.

Quality Management System Training Presentations and Exams Read More »

Oct 7 2013

Procedure template for ISO ISO 13485:2016 quality systems

5 Comments / ISO Certification / By Robert Packard / documentation, procedure, QMS, Quality Management System, template

This 12-part procedure template for your medical device QMS can result in writing shorter, more effective documents that facilitate training.

Procedure Template

We all have a standard template for our quality system procedures. Typically, we begin with purpose, scope, and definitions. This 12-part procedure template for your medical device QMS can result in shorter, more effective documents that are easier to train personnel on.

1. Purpose. Often I read something like, “This purpose of this document is to describe the CAPA procedure.” That necessary information is the reason why we title procedures. A better statement of purpose would be, “The purpose of this procedure is to provide a process for identifying, preventing and eliminating the causes of an actual or potential nonconformity, and using risk management principles.” The second version gives readers a better indication of the purpose of the procedure.

2. Scope. This section should identify functions or situations that the procedure applies to, but it is even more critical to identify which situations the procedure does not apply to.

3. References and Relationships. Reference documents that apply to the entire quality management system (e.g., – ISO 13485 and 21 CFR 820) only need to be listed in the Quality Manual. This reduces the need for future revisions to the procedures. I list here any procedure-specific external standard (e.g., – ISO 14971) in the applicable procedure. The relationship between procedures is more important than the references. Therefore, I prefer to use a simple flow diagram, with inputs and outputs, similar to the one below for a document control process.

4. Document Approval. Who must sign off on the procedure? Keep this list short. Ideally, just the primary process owner and Quality Manager (to ensure consistency and integrity across the quality management system).

5. Revision History. A brief listing of each revision and a brief description of what was changed in the procedure.

6. Responsibilities and Authorities. A listing of the main areas of responsibility for each role. Remember to include the title of managers who may be required to approve forms, or make key decisions.

7. Procedure. I prefer to create a detailed flowchart outlining each step of a process before writing the procedure. Each task box in the flowchart will include a reference number. If you organize the reference numbers in an outline format, then you can write the text of your procedure to match the flowchart—including the numbering of the flowchart task boxes.

8. Monitoring and Measurement. An explanation of how the process is monitored and measured, who does it, how often, format, method of communicating the analysis, and what process that analysis will be input into, e.g., Management Review.

9. Training/Retraining. Tabulated, which roles need to be trained in this procedure, and to what level? The example below is also from a Document Control procedure.

10. Risk Management. This section identifies risks associated with each procedure and how the procedure controls those risks. As well as complying with the requirement to apply risk management throughout product realization (i.e., Clause 7 of ISO 13485), including a section specific to risk management forces the author of the procedure to think of ways the process can fail and to develop ways to avoid failure. Risks can also be a starting point for training people on the procedure.

11. Records. Tabulated, form number and names, a brief description of its purpose, and a column for retention and location. This column also allows for reference to compilations if the record becomes part of, e.g., the Design History File, Device Master Record, or the Risk Management File.

12. Flowcharts. Step-by-step through the process, saying who performs the step when it isn’t apparent. I keep task shapes simple: rectangles for tasks, rounded rectangles for beginnings and endings, diamonds for decision boxes, and off-page reference symbols.

When the task needs supporting text, e.g., guidance or examples, put a number in the box and a corresponding number in the table in (7) above. Ideally, the flowcharts are placed in the document with the Notes table on the same page or the opposite page. In practice, I often put them at the end to simplify the layout. One of my clients loves her flowcharts and puts them on the front page.

Benefits of this Approach

Information is well structured and presented consistently across procedures, more so than can be achieved through narrative.

The flowchart is the primary means of documenting the procedure.
Tables provide details that are not clear in the flowchart.

The procedure structure described above facilitates a consistent training approach built around the document. Purpose and scope are presented first, and then the Risk section is presented to explain what is essential in the procedure and why. The flowchart, the table, and the formwork together describe each step of the procedure. Finally, a PowerPoint template can be used to guide process owners in developing their training.

And to make it even easier, you have already spelled out who needs to be trained and to what level.

Procedure template for ISO ISO 13485:2016 quality systems Read More »

Sep 9 2013

Certification Body Selection

4 Comments / ISO Certification / By Robert Packard

The author reviews the certification body selection process for ISO 13485 certification, MDSAP Certification, and CE Marking.

What is a Certification Body?

A certification body is a third-party company that is accredited by an organization like the ANSI-ASQ National Accreditation Board (ANAB) or Standards Council of Canada (SCC) to perform certification audits against ISO Standards, such as ISO 9001 or ISO 13485. Accreditation bodies verify the conformity of certification audits to the ISO/IEC 17021 Standard. Some certification bodies are not accredited or may be self-accredited. Still, you will need a certification body that is accredited to meet the regulatory requirements of Health Canada and European Competent Authorities.

Certification body selection for your company is a critical step on the journey toward ISO 13485 certification. When I first joined one of my previous companies, I was assigned the task of implementing ISO 13485 to comply with the Canadian Medical Device Regulations (CMDR) under the Medical Device Single Audit Program (MDSAP). First, I discovered that the company already had two certification bodies. The company initially received an ISO 9001 certificate from one certification body, and then a few years later, an ISO 13485 certificate was issued by another certification body. Unfortunately, neither certification body was recognized by Health Canada. Therefore, when I joined the company, and we were seeking a Canadian Medical Device License, we had to find a third certification body. This time, I selected a registrar recognized by Health Canada. Then I was able to transfer our ISO 9001 certificate to the new registrar and eliminate the other two certification bodies.

When conducting certification body selection, you will find that there are different names for the term, depending on the country to which you are seeking your certificate. For some of the biggest markets, they are named as follows:

Europe – notified bodies
Canada – registrars
Japan – registered certification bodies
Australia – conformity assessment bodies

8 Points to Consider When Selecting a Certification Body

Refer to the official Europa page that helps you identify the complete list of “possible” Notified Body candidates based on the product category.
The size and reputation of the notified body can have an impact on your customer’s confidence in your QMS. If they are savvy, they know who the key players are, and who has the more credible reputations in the medical device field. Before transitioning to BSI, I experienced “eye-rolling” during customer audits when asked for the name of our notified body.
Consider the level of risk associated with the classification of the medical devices that are currently marketed and those that may be planned for future distribution. The EU Commission and Competent Authorities (US FDA equivalent in European member states) throughout Europe are currently re-evaluating all the Notified Bodies to determine if they will continue to be allowed to issue CE Design Examination Certificates (Annex II.4) and CE Type Examination Certificates (Annex III) for the highest risk devices (i.e., – Class IIb and Class III).
Identify all your regulatory needs unless you want to contract multiple certification bodies (not recommended). Certification bodies are not created equal, and some may not be qualified to provide all the services needed. A certification body qualified to issue a certificate for ISO 13485 may not be able to provide a CE certificate for CE Marking required by the EU, and only 15 certification bodies are recognized by Health Canada as MDSAP Auditing Organizations. To avoid the need for additional certification bodies in the future, you need to identify your long-term certification requirements for the international markets you will be distributed in.
Compare price quotes from each certification body you are considering and make sure that you provide the same criteria to each potential certification body to ensure that you are getting a fair quote. This is also the time to determine ALL costs associated with audits, certificates, and any other fees. Be sure to include any travel costs, as they are part of the fees that will be included in the contract. If you have multiple sites, consider the benefit of utilizing the same auditor for each site for consistency. However, using one auditor can also incur higher travel costs.
Evaluate each certification body’s customer service before the initial certification audits by asking for “360-degree” evaluations by everyone in your organization that will interact with the certification body directly. This includes planners scheduling the certification audits, the accounts receivable department handling invoices for the certification body, and your sales team that may be able to represent a customer’s opinion of the various certification bodies you are considering. Responsiveness is one of the best criteria to evaluate this customer service against. If the certification body is difficult to work with before certification, it won’t get better.
What is your regulatory strategy? Are you looking for a certification body that will conduct an audit that barely meets requirements? Or maybe you want a certification body that will work with you as a partner to build a QMS made up of best practices. I recommend a “picky” certification body. This will ensure that you choose a partner that forces you to improve your QMS and remain competitive with other medical device companies that have embraced the principles of an ISO QMS.
Finally, if your medical devices or the manufacturing process is complex or innovative, you should select a certification body with auditors that have the technical expertise to understand your product and processes. For example, if your company makes special plastic implants that require “gas plasma,” or vapor-hydrogen peroxide sterilization, you want to ensure that the certification body has auditors that understand this sterilization process.

Strategic Decision-Making

For certification body selection, a spreadsheet may help keep track of information. However, the best practice for making this type of strategic supplier decision is a “Proposal A3 Report”. This special type of A3 Report is explained in Dan Matthew’s workbook. Rob Packard, the founder of the Medical Device Academy, used this approach for the certification body selection of a new Notified Body to transfer to for a recent client.

If you need assistance with ISO 13485 Certification or are interested in training on medical device regulations for the United States, Europe, or Canada, please email the Medical Device Academy at rob@13485cert.com, or contact Rob Packard by phone @ +1.802.258.1881.

Certification Body Selection Read More »