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Smile, because you should never be scared of a surprise FDA inspector

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If you have a surprise FDA inspector visit, you should never be scared because there is no difference between the best and worst-case outcome.

Why are you scared of an FDA inspector?

There are a number of reasons why you might be scared of an FDA inspector, but if you keep reading you will learn why 95% of your fear is self-induced. A small percentage of device manufacturers evaluate the performance of quality managers based on the outcome of FDA inspections, but you have no control over whom the FDA Office of Regulatory Affairs (ORA) assigns to perform your inspection. If your company belongs to this 5% minority, you need to change top management’s approach to regulators or you need to find a new employer. For the majority of us, we are scared of embarrassment, failure, or being “shut down.”

There are rare examples of where the FDA has taken action to stop the distribution of medical devices, but this is only done as a last resort. Usually, companies cooperate with the FDA with the hope of being able to resolve quality issues and resume distribution after corrective actions are implemented. Not only is this type of action rare, but there will be a prior visit to your facility and prior written communication from ORA before you receive a warning letter–let alone removal of your company’s device(s) from the market. You can’t pass or fail an FDA inspection. The FDA inspector is verifying compliance with the FDA Quality System Regulation (i.e. 21 CFR 820) as well as the requirements for medical device reporting (i.e. 21 CFR 803), reports of corrections and removals (i.e. 21 CFR 806), investigational device exemptions (i.e. 21 CFR 812), and unique device identification (UDI). FDA inspectors only have time to sample your records, and with any sampling plan, there is always uncertainty. When you do receive an FDA 483 inspection observation you should not consider it to be a condemnation of your company. Likewise, an absence of 483 observations is not a reason to celebrate.

Why you should not be embarrassed when you receive a 483 from an FDA inspector

The most irrational response to an FDA 483 inspection observation is embarrassment. Our firm specializes in helping start-up medical device companies get their first product to market. This includes providing training and helping them to implement a quality system. When our clients have their first FDA inspection, it is not uncommon to receive an FDA Form 483 inspection observation. Start-ups have limited resources and limited experience, and most of the employees have never participated in an FDA inspection before. Experience matters and immature quality systems have only a limited number of records to sample. Any mistakes are easy for an inspector to find.

Instead of feeling embarrassed, acknowledge and embrace your inexperience. For example, during the opening meeting with an FDA inspector, you might say, “We are a new company, and this is our first FDA inspection. I am also a first-time quality manager. If you find anything that we are doing incorrectly, please let us know and we will make immediate corrections and start working on our CAPA plan.” You can say this with a smile :), and you can genuinely mean what you said because it’s true.

Anticipation is always worse than reality

Another reason you are scared of an FDA inspection is that you don’t know exactly when the inspection will be. Only Class III PMA devices, and a few Class II De Novo devices with novel manufacturing processes, require a pre-approval inspection. For the rest of the Class II devices, ORA prioritizes inspections based on risk. There are a few companies prioritized for inspection within the first six months of your initial FDA registration, such as reprocessors of single-use devices and contract sterilizers. For the rest of the Class II device manufacturers, your first inspection should be approximately two years after your company registers with the FDA. If you are located outside the USA (OUS), your first inspection might take three years to schedule. Finally, Class I device manufacturers and contract manufacturers, are unlikely to ever be inspected by the FDA. If you didn’t know what the typical timeline was for ORA to schedule your first inspection, you probably just breathed a HUGE sigh of relief when you read this paragraph.

Even if you already know the approximate timeline and priorities for FDA inspections, it’s normal to feel a little anxiety when the date of your first visit is unknown. Your boss and the rest of the top management are probably feeling just as much anxiety as you are, or even more if they have no idea what the timeline and priorities are. You should make sure that everyone in your company understands what they are supposed to do during an FDA inspection, and if you forget to tell them you might cause a lot of unneeded drama when they find out an FDA inspector is in the front lobby. Preparing for an FDA inspection is no different from conducting a fire drill. Everyone should know the procedure, and you should practice (i.e. conduct a mock FDA inspection). Practice ensures that everyone knows what to do during the first 30 minutes of an FDA inspection, and nobody in your company will panic when an FDA inspector actually arrives.

Let’s define “surprise” visits by an FDA inspector

A surprise visit from an FDA inspector is extremely rare, but in the USA inspectors will call on Friday to confirm that your company will be open the following Monday for an inspection. The FDA has jurisdiction over medical device manufacturers located in the USA, and they are not required to give advanced notice. However, inspectors need time to prepare in advance for their inspection–just like an ISO 13485 auditor. Therefore, before an inspector arrives on-site for a routine (Level 2) inspection, the inspector will first make a courtesy call to the official correspondent identified in your establishment registration.

What happens when an FDA inspector travels outside the USA

In the case of OUS medical device manufacturers, the FDA inspector does not have jurisdiction. Therefore, they will contact the official correspondent 6-8 weeks in advance to schedule an inspection. Inspectors will typically make contact via email, and you may be given a couple of weeks to choose from for the FDA inspection. The duration of your inspection should be 4.5 days. The inspector will arrive on Sunday, and the inspection will begin on Monday morning. The inspector has four major process areas to cover, and Friday morning will be focused on generating a preliminary report of 483 inspection observations. The reason why you can predict this OUS routine with a degree of certainty is two-fold: 1) these are government workers following a procedure, and 2) the FDA inspector needs time to get to the airport for their flight home.

What is the outcome of an FDA inspection?

FDA inspections have three possible outcomes:

  1. No action indicated – there were no FDA 483 inspection observations identified by the FDA inspector
  2. Voluntary action indicated – there was at least one FDA 483 inspection observation identified by the FDA inspector, and the FDA inspector requests submission of a CAPA plan to prevent recurrence
  3. Official action indicated – there was at least one FDA 483 inspection observation identified by the FDA inspector, and the FDA inspector requires submission of a CAPA plan to prevent recurrence; if a plan is not received in 15 business days, a warning letter will automatically be generated on the 16 day

Even in the rare instances with there is “no action indicated” (i.e. best case scenario), I have always noticed one or more things during an FDA inspection that were overlooked and we needed to initiate a new corrective action plan(s). In the other two possible scenarios, the FDA inspector identified the need for one or more corrective action plans. Therefore, regardless of whether your FDA inspection results in the best-case scenario or the worst-case, you will always need to initiate a new corrective action plan(s).

If the outcome is always a CAPA, what should you do?

Give your FDA inspector a big smile and say, “We are a new company, and this is our first FDA inspection. I am also a first-time quality manager. If you find anything that we are doing incorrectly, please let us know and we will make immediate corrections and start working on our CAPA plan.” Making sure that you have a genuine smile is just as important as what you say. Smiling will relax you and the anxiety and stress you are feeling will gradually melt away. Smiling will encourage the FDA inspector to trust you. Maybe your smile will even be contagious.

If you need help responding to an FDA 483 inspection observation, or you want to conduct a mock-FDA inspection, please use our calendly app to schedule a call with a member of our team. We are also hosting a live webinar on FDA inspections on July 26, 2021 @ Noon EDT.

About the Author

Rob Packard 150x150 Smile, because you should never be scared of a surprise FDA inspector

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 certification. From 2009-2012, 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 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

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FDA inspection webinar (training bundle)

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Learn how to host an FDA inspector and receive work instructions when you purchase our FDA inspection webinar training bundle.

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What you will learn during the FDA inspection webinar

Everyone in your company needs to know their repsonsibilities during an FDA inspection, and this FDA inspection webinar bundle will help you prepare everyone in your company. As the official correspondent to the FDA, you need to know what to ask on Friday afternoon when the FDA inspector calls you. The person greeting guests in your company’s lobby needs to know how to verify the identity of the FDA inspector and who should be notified in your company when the inspector arrives. Everyone in the company should know where the inspection meeting room is located in your company, and the FDA inspector should be taken immediately to that room. Don’t make them wait in the lobby. How you handle the first 30 minutes of an FDA inspection makes an important first impression on the FDA inspector.

Once the FDA inspection begins, each person in your company needs to know how they should be helping to host the FDA inspector. We discussed this during the training webinar on July 26, 2021. We are also providing this information in work instruction format (i.e. WI-009).

What will you receive when you purchase this FDA inspection webinar bundle?

Anyone that purchases this FDA inspection webinar bundle will receive a Zoom invitation to the live Zoom webinar, the “FDA Inspection Work Instruction (WI-009)” in the native Word format, any future updates to the work instruction, access to a recording of the webinar, and a quiz for verifying training effectiveness.

When is the live FDA inspection webinar scheduled?

The webinar was conducted live on Monday, July 26, 2021 @ Noon EDT. The recording is 1 hour and 21 minutes in duration. A link for downloading the recording and native slide deck are provided upon confirmation of your purchase. The “FDA Inspection Work Instruction (WI-009)” is also attached to the email providing the download links.

Q&A

During the live FDA inspection webinar, we had some great questions. We also had some follow-up questions off-line. We will be converting this into an FAQ document and sending that as a follow-up to the original content. If you have company-specific questions, please use our calendly app to schedule a call with the instructor. If you are purchasing this webinar after July 26, 2021 you can still submit questions by email. You can also use our Suggestion Portal.

FDA Inspection Webinar Bundle available for $299.00:

2 3D FDA inspection webinar (training bundle)
Hosting an FDA inspection (Training Bundle)
This paid webinar will be 1-hour plus Q&A. You will learn how to prepare for an FDA inspection. You will also receive a copy of our new work instruction (WI-009) for hosting an FDA inspector that defines what you should do during the first 30 minutes of the inspector's arrival, throughout the inspection, and in response to any FDA 483 inspection observations. There will also a quiz available for training effectivess. FDA Inspection Webinar Topics include: - FDA’s approach to conducting inspections - How FDA prioritizes inspections - QSIT approach-7 major and minor sub systems - Types of FDA inspections - Records exempt from FDA inspection - “Back room” preparations for organizing the inspection - FDA 483 dataset analysis (i.e. most common 483s in 2020)
Price: $299.00

This FDA Inspection Webinar Bundle and the “FDA Inspection Work Instruction (WI-009)” are available for $299. If you would like a quotation for a mock-FDA inspection or you would like to ask confidential questions, please use our calendly app to schedule a call with the instructor.

Important Note

This FDA inspection webinar will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. The email may be in your spam folder.

Additional resources to prepare for an FDA inspection

In addition to our FDA inspection webinar, you may also be interested in the following blog articles related to FDA inspections:

About the Instructor

Rob Packard 150x150 FDA inspection webinar (training bundle)

Rob 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 certification. From 2009-2012, 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 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

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Additional Information Request is different from an RTA

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A poor RTA response will cause a two-week delay, but an additional information request only gets one chance to avoid the dreaded NSE letter.

An Additional Information Request (i.e. AI Request) is typically received just before the 60th day in a 90-day 510k review, while a Refusal to Accept (RTA) Hold is typically received on the 15th day. If your response to your first RTA Hold (i.e. RTA1) is inadequate, the reviewer will issue another RTA Hold letter (i.e. RTA2) and your 510(k) review clock will be reset to 0 days. You will have another 180-days to respond to RTA2, and issues identified in an RTA Hold are usually easy to address. Most RTA Hold issues also have one or more guidance documents that are available to help you to obtain an RTA Accept letter. You can always request a submission-in-review (SIR) meeting to clarify what information the reviewer needs to address the RTA deficiencies too. If you want to learn more about responding to an RTA Hold, please read last week’s blog. The rest of this article is specific to responding to requests for additional information.

What happens after 60 days during a 510k review?

On the 60th day of the 510k review clock, or a few days prior to the 60th day, the lead reviewer must determine if they need to issue an Additional Information (AI) Request. The alternative to an AI Request is for the lead reviewer to issue a letter indicating that you have entered the Interactive Review Phase. This only happens if the reviewer believes they can make a decision regarding substantial equivalence in the next 30 days. If the decision is to issue an Interactive Review Letter, then the lead reviewer believes that only minor issues remain and there is only the need for interactive email responses between the lead reviewer and the submitter. An interactive review is the ideal outcome of the substantive review process but it rarely happens.

If you receive an Additional Information Request, what are your options?

The AI letter will indicate that you have 10 days to request a clarification meeting with the reviewer. The wording of this section of the AI letter is provided below:

“FDA is offering a teleconference within 10 calendar days from the date on this letter to address any clarification questions you may have to pertain to the deficiencies. If you are interested in a teleconference, please provide (1) proposed dates and (2) a list of your clarification questions via email at least 48 hours before the teleconference to the lead reviewer assigned to your submission. We would like to emphasize that the purpose of the meeting is to address specific clarification questions. The teleconference is not intended for the review of new information, test methods, or data; these types of questions could be better addressed via a Submission Issue Q-Submission (Q-Sub). For additional information regarding Q-Subs, please refer to the Guidance for Industry and FDA Staff on Medical Devices: Requests for Feedback and Meetings for Medical Device Submissions at https://www.fda.gov/media/114034/download.”

If you wait too long to request the teleconference, then FDA will require you to submit a formal pre-sub request or “Submission in Review” (SIR) meeting request. If you request a SIR meeting within 60 days of receiving an AI Request, the FDA will schedule a SIR meeting with you within three weeks of receiving the request–assuming resources are available. If you wait longer than 60 days to request the SIR meeting, then the FDA will default to their normal target of 60-75 days for scheduling a pre-sub meeting. For example, if you submit your SIR meeting request on day 75, and the FDA takes 75 days to schedule the meeting, you will be granted your SIR meeting at 150 days and you will only have 30 days remaining to respond to the AI Request before your submission is automatically withdrawn.

Therefore, it is important to request a clarification meeting immediately after you receive the AI Request. While you are waiting for your clarification meeting, you should immediately begin preparing any draft testing protocols that you want the FDA to provide feedback on during a SIR meeting. Then after you have the clarification meeting, you should submit your SIR meeting request and include any draft testing protocols you have prepared. This may include a statistical sampling rationale, a proposed statistical analysis method, a summative usability testing protocol, or a draft protocol for some additional benchtop performance testing. The FDA can review examples of preliminary data, a protocol, or a proposed method of analysis. The FDA cannot, however, provide a determination of substantial equivalence.

The Most Common Mistakes in Responding to an Additional Information Request

Most companies make the mistake of asking the lead review if they provide specific additional information, “Will this be sufficient to obtain 510(k) clearance?” Unfortunately, the FDA is not able to provide that answer until the company has submitted the additional information and the FDA review team has had time to review it thoroughly. This is done only when the submitter delivers an FDA eCopy to the Document Control Center at CDRH, and the review team is able to review the information. This new information is assigned a supplement number (e.g. S001), and it will typically require three weeks to review the information. Then the lead reviewer may request minor modifications to the labeling, instructions for use, or the 510k summary. This request is an interactive request, and the submitter must respond within a very short period (e.g. 48 hours), and the wording of the request may be “Please provide the above information by no later than COB tomorrow.”

FYI: “COB” means “close of business.” Wow. The FDA loves acronyms.

Best Practices in Responding to an Additional Information Request

If you receive an AI request on a Friday afternoon, 58 days after your initial submission, you should immediately request a clarification teleconference with the FDA reviewer for the following week. The only exception is if you only have minor deficiencies that you feel are completely understood. During the days leading up to the clarification teleconference, your team should send a list of clarification questions to the lead reviewer and begin drafting a response memo with a planned response to each deficiency. After the clarification meeting, you will have approximately 6-7 weeks to submit a SIR meeting request. However, you should not wait that long. Your team should make every effort to submit your SIR meeting request within 2-3 weeks. If the FDA takes 3 weeks to schedule your meeting, then you will have used approximately 6 weeks of your 26 weeks to respond to the AI Request.

In your SIR meeting request, you should always try to provide examples or sample calculations to make sure the FDA review team understands what you are proposing to submit in your supplement. For example, the FDA reviewers do not have enough time to review your entire use-related risk analysis (URRA) in a SIR meeting request. However, you can provide an example of how you plan to document a couple of use-related risks. Then you can show how these risks would translate into critical tasks. Finally, you could provide a draft summative usability testing protocol for FDA feedback. The FDA review team doesn’t have enough time available to review much more. You will only have one hour for your SIR meeting.

How to Prepare Your Response

In section “V” of the FDA guidance on deficiency responses, the FDA recommends that you restate the issue identified by the reviewer in your response. Next, your response should include one of the following:

  1. the information or data requested, or
  2. an explanation of why the issue is not relevant, or
  3. alternate information with an explanation of why the information you are providing addresses the issue.

Before you respond to an AI Request, you should look up any FDA guidance documents referenced in the AI Hold letter to make sure that you address each requirement in the applicable FDA guidance document(s).

The most important technique to learn when you are responding to regulators is to organize your response in a tabular format that is numbered in exactly the same order that the request was made. Typically there will also be sub-parts to certain issues. In that case, you should duplicate the numbers and/or letters of each sub-part and segregate each sub-part in a different row of the table. Personally, I like to alternate the color of the font I use in the table to make it even more obvious which information is a restatement of the reviewer’s comment and which information is the company’s response to the AI Request.

Why you don’t get a second chance to respond to an AI Request

Once you respond to an AI Request, and the DCC receives your FDA eCopy, the FDA review clock will then resume the countdown to 90 days. In our example above, you received the AIR Request on the 58th day. The FDA must review everything you submitted and make a final substantial equivalence decision before the 83rd day because they still need to submit their recommendations to senior management in their branch. If any changes to the labeling, instructions for use, or the 510k are required, you should receive those requests several days before (i.e. 76-83 days). You can respond to interactive requests via email, and then the final SE decision will be made. If you do not respond to all of the deficiencies in the AI Request, the FDA reviewer will not have enough time to request that you address the remaining gaps and finish their review. Therefore, an incomplete AI Response will certainly result in a non-substantial equivalence (NSE) letter.

If you need to respond to an additional information request from the FDA reviewer, we can review your planned response to identify potential gaps. If you need help please use our calendly app to schedule a call with a member of our team.

About the Author

Rob Packard 150x150 Additional Information Request is different from an RTA

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 certification. From 2009-2012, 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 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

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What are the secrets to success in responding to an FDA RTA Hold?

2 Comments / 510(k) / By

When an FDA reviewer places your 510k on RTA Hold, there are secrets you can learn to improve your chances of a successful response.

Test your knowledge about the FDA RTA Hold process

Did you know that approximately 50% of 510(k) submissions are placed on RTA Hold? Did you know that you can be placed on RTA Hold multiple times for the same submission? Did you know that the 90-day review clock is reset to “0” when you submit your response? Do you know how to respond to the FDA when the reviewer is incorrect? Did you know that you can avoid the RTA screening process for any 510(k) submission if you use the correct template? Every year there are more than 1,000 submissions placed on RTA Hold, but did you know there is an FDA guidance specifically telling you how to respond to deficiencies? You can learn the secrets to responding to an FDA RTA Hold just by reading this article.

What is an FDA RTA Hold?

When the FDA receives a Traditional 510k submission FDA eCopy, the eCopy is uploaded to the FDA system within hours of the submission being received. If the eCopy does not meet the eCopy format requirements, then the submission will be placed upon eCopy Hold. The official correspondent will receive an automated email indicating that the submission is on eCopy Hold, and the submitter will be asked to correct the submission format to meet the eCopy submission requirements and provide a replacement eCopy. If the FDA user fee has not cleared, then the submission will be placed on User Fee Hold. It is possible to be placed on eCopy Hold and User Fee Hold at the same time.

If your eCopy is accepted, then a reviewer is assigned to screen your submission for compliance with the FDA Refusal to Accept (RTA) policy. The reviewer has 14 days to complete this review, and on the 15th day the reviewer must do one of three things: 1) issue a RTA Hold letter to the submitter, 2) issue an RTA Acceptance letter to the submitter, or 3) issue a letter that states the RTA screening was not completed on-time and the submission was automatically accepted. If your receive an RTA Hold letter, it will be via email from the reviewer and the RTA Checklist will be attached. In the checklist, there will some items highlighted in yellow and deficiencies will be noted in those sections. The reviewer may add additional comments to the checklist, but you are only required to respond to the highlighted sections. The process that the reviewer follows for RTA screening is defined in the FDA guidance for the Refusal to Accept process, and the guidance includes a checklist for traditional, abbreviated, and special 510k submissions. Some companies will fill in these checklists themselves and submit a copy of the checklist with the 510k submission. This is intended to help the reviewer identify where all of the requirements in the RTA checklist can be found. Third-party reviewers require that the company complete the RTA checklist and provide it to them with the eCopy.

How many times can you be placed on hold for the same submission?

Technically there is no limit to the number of times a submission can be placed on RTA Hold, and our firm has seen a few submissions placed on RTA Hold twice in a row. The first RTA Hold is referred to as RTA1, and the response to that RTA Hold is referred to as the first supplement (i.e. K123456/S001). If a second RTA Hold is issued, that hold is RTA2, and the response to that RTA Hold is referred to as the second supplement (i.e. K123456/S002). A response to an eCopy Hold is referred to as an amendment (i.e. K123456/A001).

What happens to the 90-day review clock when you are placed on RTA Hold?

When the FDA reviewer places your submission on RTA Hold, the 90-day review clock is automatically reset. Therefore, even if you respond to an RTA Hold on the same day you receive the RTA Hold, and your submission is received the next day, the “real” review timeline is now 106 days instead of 90. If your submission is placed on RTA Hold twice, then the “real” review timeline is now 122 days instead of 90. If the lead reviewer of your 510k requests additional information, this is referred to as an “AI Request.” We will address this in a future blog, but an AI Request does not reset the review timeline. The AI Request, however, will increase the review timeline. Although we rarely have an RTA Hold, we almost always have an AI Request. This is why our average submission is approximately 125 days (i.e. ~30 days are required to respond to the AI Request.

How should you respond if the FDA reviewer is incorrect?

The average 510(k) submission has grown over time from 300 pages to more than 1,200 pages, but the FDA review “clock” is still 90 days and the RTA screening is limited to 15 days. Therefore, it is not reasonable for you to expect the reviewer to understand and absorb every detail of your submission. If the reviewer can’t find the information they are looking for quickly, the reviewer may state that they could not find the information in the submission or that you did not provide it. If the information is found in the submission, you should provide a reference to the section of the submission, including the document and page number, in your RTA response. You may even choose to quote the information in your response memo if it is brief.

Other times the reviewer may not understand why certain information is not relevant to your submission. In this case, you should restate why the information requested is not relevant. You may want to review relevant FDA guidance documents that explain how to justify why information is not required.  For example, if you did not provide biocompatibility testing reports for some of the endpoints that are identified in ISO 10993-1:2018, then you should either provide a detailed biological risk assessment in accordance with the FDA guidance on the use of ISO 10993-1, or you should provide a biocompatibility certification statement.

If you are not sure why the FDA reviewer stated the information you provided is not acceptable, you might try calling or emailing the reviewer to ask for clarification. If you do this, be respectful of their time and be brief. You should identify who you are (you must be the official submission correspondent to speak with the reviewer), you should identify which submission you are contacting the reviewer about (they are working on many simultaneously), you should restate the issue identified by the reviewer (it may have been an issue of another member of the review team), and then you should indicate where the information can be found in the submission. If they believe this addresses the issue, then they will instruct you to provide that information in an RTA response. If the information does not address the issue, usually they will explain why. Your chances of receiving an email response are also better than speaking to the person on the phone–especially during the Covid-19 pandemic.

FDA eSTAR submissions are not subjected to the RTA screening process

When you use the FDA eSTAR submission instead of creating an eCopy, your submission should already meet all of the RTA screening requirements. The eSTAR includes automation to validate that the submission is administratively complete and therefore the reviewer does not need to do an RTA screening of an eSTAR submission. Therefore, most companies should realize a shorter overall 510k clearance timelines, because they will only have an AI Request and the review clock will not be reset.

Does the FDA offer any guidance on how to respond to deficiencies?

When the FDA writes deficiencies, the reviewer is supposed to follow the FDA guidance for deficiency content and format. However, the RTA checklist deficiencies typically are shorter and may not be as clear as a deficiency in additional information (AI) requests or non-substantial equivalence (NSE) letters. The first part of the deficiency is a reference to the information that was provided by the submitter (i.e. section, page number, or table). In an RTA checklist, each deficiency is provided in the comments section at the end of the section of the checklist. Therefore, if you have a deficiency related to your device description, the deficiency will be written at the end of the device description section of the RTA checklist. The comment will be highlighted in yellow, and there will be a checkbox next to the specific checklist item indicating that the requirement was not met. In the far-right column of the checklist, there will be a reference to the page of the submission where the deficiency can be found.

In the comment there reviewer should explain why the current information does not meet the requirement of the RTA checklist. The reviewer should also clarify the relevance of the deficiency with regard to the substantial equivalence determination. For the example of a deficiency related to your device description, usually, the issue is that your submission has inconsistencies between the various submissions or there is insufficient detail about your device. At the end of the comment, the reviewer should provide an explicit request for the information needed to address the RTA Hold.

In section “V” of the FDA guidance on deficiency responses, the FDA recommends that you restate the issue identified by the reviewer in your response. Next, your response should include one of the following:

  1. the information or data requested, or
  2. an explanation of why the issue is not relevant, or
  3. alternate information with an explanation of why the information you are providing addresses the issue.

Before you respond to an RTA Hold, you should look up any FDA guidance documents referenced in the RTA Checklist to make sure that you address each requirement in the applicable FDA guidance document(s).

The most important technique to learn when you are responding to regulators is to organize your response in a tabular format that is numbered in exactly the same order that the request was made. Typically there will also be sub-parts to certain issues. In that case, you should duplicate the numbers and/or letters of each sub-part and segregate each sub-part in a different row of the table. Personally, I like to alternate the color of the font I use in the table to make it even more obvious which information is a restatement of the reviewer’s comment and which information is the company’s response to the RTA Hold.

Regardless of how well your response is organized, you must respond within 180 days. On the 181st day, your submission will be automatically withdrawn. The agency has granted extensions of an additional 180 days during the Covid-19 pandemic, but that will end and you should verify if you can obtain an extension from the reviewer rather than assume that this will happen. If the 180th day is on a weekend or US holiday, the Document Control Center (DCC) at the FDA will not receive your submission until the next business day. Therefore, you will need to ship your submission earlier to ensure the delivery is received on time. Since most companies are shipping their RTA response via FedEx or UPS to the FDA, you also will want to make sure you take into account customs clearance for international shipments and local holidays where you are. If you are shipping from the UK, for example, you can’t expect FedEx to ship on a British holiday. If you need help with printing and shipping your RTA response, Medical Device Academy offers an eCopy print and ship service for $99/eCopy (including the overnight FedEx fee).

If your 510k submission was placed on RTA Hold by the FDA, we can help you respond to the deficiencies identified by the FDA reviewer. We can also review your planned response to identify potential gaps. If you need help please use our calendly app to schedule a call with a member of our team.

About the Author

Rob Packard 150x150 What are the secrets to success in responding to an FDA RTA Hold?

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 certification. From 2009-2012, 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 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

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Which changes are forgotten in your MDR labeling procedure?

1 Comment / CE Marking / By

Did you forget any of the MDR labeling procedure requirements when you were updating your device labeling for CE Marking?

MDR Labeling Procedure

Don’t forget to subscribe to our YouTube channel for more medical device quality and regulatory training. The topic of this article is how to create an MDR labeling procedure for compliance with Regulation (EU) 2017/745 (MDR) for CE Marking of medical devices. The MDR does not actually include a requirement for a labeling procedure. In fact, the MDR doesn’t even specifically require that you have ISO 13485:2016 certification. ISO 13485:2016, clause 7.5.1 states that you shall implement “defined operations for labeling and packaging,” but the standard doesn’t specifically say that “the organization shall document procedures” for labeling. In 21 CFR 820.120, the FDA states that “each manufacturer shall establish and maintain procedures to control labeling activities.” But there is no similar requirement in the MDR.

MDR Quality System Requirements

Article 10 is the section of the MDR that defines the obligations for device manufacturers to create quality system procedures, but a labeling procedure is not specifically mentioned. Article 10(9)(a) states that your quality system shall include “a strategy for regulatory compliance, including…procedures for management of modifications to the devices covered by the system,” and this would include label changes and other control of other design changes. The next paragraph states that your quality system shall include, “identification of applicable general safety and performance requirements.” The general safety and performance requirements (GSPRs) are found in Annex I of the MDR, and the very last GSPR (i.e. GSPR 23) is for your label and instructions for use.

Then, which changes do you need to make for the MDR labeling procedure?

The GSPRs in Annex I of the MDR are longer than the Essential Requirements that were in the MDD. In addition to the new requirements for UDI compliance (which you should address in a UDI Requirements Procedure), GSPR 23 has new general requirements (i.e. 23.1) and new requirements for information on the sterile packaging (i.e. 23.3). There is also a more detailed specification for the information on the label (i.e. 23.2) and the information in the instructions for use (i.e. 23.4). The approach for demonstrating compliance with the GSPRs suggested in the MDR is to provide a checklist. Therefore, most manufacturers of CE Marked devices have replaced their Essential Requirements Checklist (ERC) with a GSPR checklist. However, if you are reviewing a draft label for approval, you don’t want to review and update your entire 22-page, GSPR checklist for every label.

The more efficient approach is to create one or more labeling checklists that are specific to the requirements in GSPR 23. If you create a separate checklist for the label, the information on the sterile packaging, and for the information in the instructions for use, then you would have three shorter checklists to complete. The label checklist and the checklist of the information on the sterile packaging would be only one page each, while the checklist for the instructions for use would be approximately four pages. There may be additional labeling requirements for specific countries and types of devices. Electrical medical equipment also has specific labeling requirements in IEC 60601-1 and IEC 60601-1-2. You will also need to create a user needs specification that can be used as criteria for summative usability testing (i.e. validation that the design and risk controls implemented meet the user needs specification). You should also document a use-related risk analysis (URRA), and perform formative testing, in order to identify critical tasks which need to be in the instructions for use to prevent use errors.

Are there any other MDR requirements that you should address in a labeling procedure?

There are two other requirements that should be addressed in your labeling procedure. The first is the general labeling requirements in GSPR 23.1. Withing GSPR 23.1, there are actually nine “sub-requirements.” The first “sub-requirement” in GSPR 23.1 is to provide the identity of the device, your company, and any safety and performance information needed by the user on the packaging or the instructions for use, and on your website. Many manufacturers do not want to make this information available on their website, because it makes it easier for competitors to copy the instructions for use, but this is not optional. This requirement and the other eight requirements in GSPR 23.1 could be included in your procedure or as part of a fourth labeling checklist associated with your MDR labeling procedure.

The second requirement is the requirement to translate your instructions for use into an official Union language(s) determined by the member state where your device will be made available to the intended user or patient. Creating these translations, and verifying the accuracy of the translations, can be expensive and burdensome–especially if your device is sold in most of the member states.

You might also consider implant cards as labeling requirements and try to add them to your MDR labeling procedure. However, if the requirement for implant cards (see Article 18 of the MDR) is applicable to your company you should create an implant card procedure instead because this is a detailed and critical requirement that will not apply to most of the other labels in your company. You should make sure that the implant card procedure is compliant with MDCG 2021-11 released in May 2021 and MDCG 20201-8 v2 release in March 2020. These guidance documents also have great examples of how to design your implant cards.

Other changes in labeling requirements

The ISO 15223-1:2016 standard has been revised and was expected for release at the end of 2020. However, only draft versions are currently available (i.e. ISO/DIS 15223-1:2020). This new version of the standard for symbols to be used with labeling will also need to be updated shortly in your MDR labeling procedure. This new version is already referenced in the medical device standard for information provided by the manufacturer (i.e. EN ISO 20417:2021)–which supersedes EN 1041:2008. Consultants and chat rooms have argued over whether the requirement for identifying the importer must be on the label or if it could be presented in other documents. EN ISO 20417:2021 resolves this dispute in section 7.1: “Where necessary, the label of a medical device or accessory shall include the name or trade name and full address of the importer to which the responsible organization can refer.” In the note following that clause, it clarifies that “This can be required by the authority having jurisdiction.” There is even a new symbol referenced for importers (i.e. Symbol 5.1.8 in ISO 15223-1).

If you have specific questions about device labeling or MDR compliance, please use our calendly app to schedule a call with a member of our team. You can also purchase our labeling and translation procedure (SYS-030) to save yourself the time and effort of making your own versions of the labeling checklist described above.

About the Author

Rob Packard 150x150 Which changes are forgotten in your MDR labeling procedure?

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 certification. From 2009-2012, 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 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

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Contract Manufacturers Need Strong Risk Management Processes

1 Comment / ISO 14971:2019 (Risk Management) / By / , ,

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.

Risk Management Training for ISO 149712019 Button 1024x337 Contract Manufacturers Need Strong Risk Management Processes

sys001 supplier quality management procedure button 1024x323 Contract Manufacturers Need Strong Risk Management Processes

sys010 risk management procedure button 1024x339 Contract Manufacturers Need Strong Risk Management Processes

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Supplier Qualification: How To Get The Best Results

1 Comment / Supplier Quality Management / By / ,

In this article, you will learn strategies for better supplier qualification to obtain the highest quality components and services.

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.” Supplier qualification is one of the most important purchasing controls. 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 auditor’s 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 questionnaire Supplier Qualification: How To Get The Best Results

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 supplement 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 people’s time with on-site interviews. Desktop audits of suppliers should not be used as a replacement for 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 audit 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.” You might consider reviewing our article on hiring an auditor.

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.

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 returned to the 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 releases 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. If you need a procedure for supplier qualification, please check our Supplier Quality Management Procedure (SYS-011).

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For more information on supplier controls, quality systems, auditing, and regulatory submissions visit our YouTube Channel!           

 

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MDSAP QMS update webinar to meet country-specific requirements

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This management review webinar is an example of the ISO 13485:2016 updated procedures and training webinars you can download from Medical Device Academy.

When you submit your registration, you will receive:

  • an invitation to the live webinar on September 17, 2020 @ 1:30 pm EDT
  • a native slide deck for the webinar
  • a link to download a recording of the webinar

What you will learn from the MDSAP QMS Update Webinar:

  • MDSAP requirements
  • Overview of Country-Specific Requirements
  • Certification Body Selection

Who should attend the MDSAP QMS Update Webinar?

This webinar, and MDSAP certification, is only for manufacturers. OEMs and contract manufacturers may benefit from ISO 13485 certification, but the MDSAP version of ISO 13485 is only applicable to manufacturers of medical devices. If your company is planning to market your product in Canada, MDSAP certification is required. If you are planning to market your product in the USA, Brazil, Australia, or Japan, MDSAP certification can simplify the process of complying with country-specific requirements. If you are the management representative for a company that plans to do business in one of those five countries, you can’t afford to miss this opportunity.

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Why remote audit duration should never exceed 90 minutes

1 Comment / Auditing, ISO Auditing, Remote Auditing / By

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

download 3 Why remote audit duration should never exceed 90 minutes

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.

unnamed Why remote audit duration should never exceed 90 minutes

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.

unnamed 1 Why remote audit duration should never exceed 90 minutes

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.

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CAPA Training – Risk-based

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This CAPA training webinar explains how to create a risk-based CAPA process, and you will learn how to implement corrective and preventive actions step-by-step.

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When is CAPA Training?

The CAPA training webinar for risk-based CAPA was recorded on June 30, 2020. Everyone who purchases the webinar will receive a link to download the recording and a copy of the native slide deck.

This CAPA training recording is only $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):

Capa how to1 CAPA Training Risk based
Create a Risk-Based CAPA Process
How to Create a Risk-Based CAPA Process. This webinar includes the most recent updates to ISO 13485:2016, ISO 9001:2015, and ISO 14971:2019.
Price: $129.00

20- Question Exam and Training Certificate available for $49.00:

Exam CAPA CAPA Training Risk based
CAPA EXAM
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
Price: $49.00

Do you also need a CAPA Procedure?

Companies that receive a non-conformity or FDA 483 inspection observation often need a new CAPA procedure as well as CAPA training. Our CAPA procedure, and all of our quality system procedures, are risk-based. Specifically, we use the GHTF grading system to score CAPAs in the same numeric scoring system used for MDSAP audit findings. Therefore, this is the perfect CAPA procedure and form for ISO 13485 certification and MDSAP certification. The CAPA procedure also includes a webinar, but the webinar focus is specific to implementing the procedure and customizing it for your company. In contrast, this risk-based CAPA training webinar explains the details of performing a CAPA investigation, identifying the root cause, writing a corrective action plan, and performing effectiveness checks.

Description of the CAPA training webinar on how to create a risk-based CAPA process

A risk-based CAPA process is a common goal of medical device manufacturers, but until recently “risk-based” was not clearly defined. The two quality management system standards, ISO 9001 and ISO 13485 were revised and re-issued. The current versions are: ISO 9001:2015 released in October 2015 and ISO 13485:2016  released in February 2016. The biggest fundamental change in both standards is an emphasis on risk-based process management. The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this CAPA training gives you a whole new set of tools for managing your CAPA process using a risk-based approach.

A risk-based CAPA process is more than prioritization

This CAPA training goes beyond simple prioritization of CAPAs and color-coding of CAPAs as high, medium, and low risks. Instead, Rob Packard reviews best practices in risk management (i.e., ISO 14971:2019 and ISO/TR 24971:2020) and he applies the more rigorous risk management process to the CAPA process.

This is a “must-see” presentation for anyone that is responsible for the CAPA process or participates in their company’s CAPA Board. Register for our CAPA training and our speaker will help you integrate risk management activities with your CAPA process.

This CAPA training includes:

  • Revised requirements for ISO 9001:2015 and ISO 13485:2016
  • An outline of the CAPA process and proposed risk management activities
  • Various risk control options that can be integrated with corrective actions
  • How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016
  • Root Cause Analysis Tools
  • 5 Why Analysis
  • Is/Is Not Analysis
  • Fishbone diagrams
  • Brainstorming
  • Pareto analysis
  • Effectiveness checks
  • Sources of corrective and preventive actions
  • Pareto analysis of service issues
  • Trending CAPAs, average aging of CAPAs, “Death by CAPA”
  • Risk Management: risk-based CAPAs, risk thresholds, 7 criteria for estimating risk
  • Documenting CAPAs
  • How to write an effective CAPA SOP
  • Auditing the CAPA process
  • Problem-solving A3 reports
  • Key elements of CAPA forms

VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:

SOPS CAPA Training Risk based

About Your Instructor


Home page video cropped 150x150 CAPA Training Risk basedRob Packard is a regulatory consultant with 30 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 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 2009-2012, 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. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone at 802.258.1881 or by email. You can also follow him on Google+, LinkedIn, YouTube, or Twitter.

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