Your CAPA procedure is the most important SOP. It forces you to investigate quality problems and take actions to prevent nonconformity.

Make sure your CAPA procedure is clear and concise

Procedures are often unclear because the author is more familiar with the process than the intended audience for the procedure. An author may abbreviate a step or skip it altogether. As an author, you should use an outline format and match your CAPA form exactly. There should be nothing extra in the procedure, and nothing left out. Medical Device Academy’s updated CAPA procedure is only six pages and the CAPA form is four pages.

SYS-024 Corrective and Preventive Action (CAPA) Procedure, Form, and Log

Medical Device Academy's newly updated CAPA procedure is a 6-page procedure. Your purchase will also include our CAPA form (FRM-009), our CAPA log (LST-005), and a training webinar. The procedure is compliant with ISO 13485:2016, 21 CFR 820.100, SOR 98/282, and the EU MDR. You will also receive free updates in the future.

Price: $299.00

When is the CAPA Procedure Webinar?

The CAPA procedure webinar will be hosted on July 22, 2024 @ 10:30 a.m. ET. The webinar will be live, and you will receive login instructions if you purchased the CAPA procedure prior to the scheduled live webinar. The webinar will also be recorded. You will be able to download the webinar from our Dropbox folder and watch the webinar as many times as needed–including the training of future employees.

What is included with the CAPA Procedure?

The following items are included with the purchase of the CAPA procedure:

1. SYS-024, CAPA Procedure
2. LST-005, CAPA Log
3. FRM-009, CAPA Report
4. Native Webinar Slide Deck
5. Webinar Recording

This CAPA procedure includes a webinar, but the focus is on implementing the procedure and customizing it for your company. In contrast, the 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. The risk-based CAPA training is recommended for anyone without prior CAPA experience.

CAPA procedure writing recommendations

Procedures are often unclear because the author is an expert with more experience than the intended audience. An author may abbreviate a step or skip it altogether. As an author, you should use an outline format and match your CAPA form exactly. There should be nothing extra in the procedure, and nothing left out. Before writing your own CAPA procedure, consider following these 7 steps:

1. Design your CAPA form first
2. Identify which steps in your process are most important and specify how these steps will be monitored (i.e., risk-based approach)
3. Write a procedure that follows your CAPA form and includes instructions for monitoring and measuring your CAPA process
4. Conduct group CAPA training using the draft version of your form and procedure
5. Make revisions to the form and procedure to clarify steps the trainees had difficulty with
6. Ask the trainees to review the revised form and procedure
7. Make final revisions and route the procedure for approval

The specific order of steps is essential to creating a CAPA procedure—or any procedure. Writing a procedure that matches the form used with that procedure helps people understand the tasks within a process. Throughout the rest of this article, we describe each of the nine steps of Medical Device Academy’s CAPA procedure (SYS-024). The actual CAPA form (FRM-009) sold with SYS-024 is more complex than 9 steps, but a more complex form is needed to make sure every sub-task is documented in your CAPA records.

Review nonconformities, including complaints, to determine if a CAPA is needed (Step 1)

If I am auditing a CAPA process, and almost all the CAPAs are resulting from auditor findings, then I know the client is not adequately reviewing other sources of potential quality issues. When I took my first CAPA training course, the image below was drawn on a flip chart by Kim Trautman. I have used this image in all of my CAPA training for other people since. I think this provides a good visual representation of the most common sources of new CAPAs. Although the number of CAPAs from each source will never be equal, you should review all of these data sources for quality issues periodically. 

CAPA procedure step 2 – Describe and reference the quality issue

The next step is to copy and paste your quality issue directly into the CAPA record and add a reference to the source. This step of the CAPA procedure is not a specific requirement of the ISO 13485 standard or the FDA regulations. However, describing and referencing quality issues in your CAPA record is a practical requirement. The person assigned to investigate the root cause of the quality issue needs to know what the source of the quality issue is, and when you are trying to close a complaint or audit report you will find it helpful to cross-reference the two records. For example, the CAPA might be related to the fifth nonconformity in your second internal audit report for 2022 (e.g. IA 220205).

Attribution: Icons were copied and pasted from Flaticon.com.

Step 3 – Perform a root cause analysis

Why can’t we fix our mistakes the first time? We are doomed to repeat mistakes when we fail to identify the root cause or causes. The person you assign to investigate a quality issue must be trained to perform a thorough root cause analysis. Successful root cause analysis depends upon four things:

1. Courage to admit that your process is broken
2. Learning more than one tool for analyzing problems
3. Practicing the use of root cause analysis tools
4. Sampling enough records (or testing enough product)

The common belief is that people fail to identify the root cause because they need root cause training (#2) or more practice (#3). However, most people fail because they stop sampling or testing too soon. I typically recommend that companies sample at least twice as many records as the suspected problem frequency. For example, if a complaint occurs 1% of the time, you should review 200 records before you can be sure you identified that root cause. If you are correct, you will only find the quality issue twice in the 200 records. However, a review of 200 records often reveals that the quality problem is more common than you originally estimated and there is more than one cause of device malfunction.

CAPA procedure step 4 – Do you need a new CAPA?

After you have successfully completed a root cause analysis, you now need to determine if a new CAPA is needed. If there is already a CAPA that is open for the same quality issue, you can use the existing CAPA as justification for not conducting corrective actions. In this case, you should include a cross-reference in the new CAPA record to the existing CAPA record. You should also document containment measures and corrections.

In both the existing CAPA record and your new CAPA record you should also be documenting your risk evaluation of your CAPA. In the latest update to our CAPA procedure, we changed the method of risk evaluation to match the MDSAP grading process for nonconformities. A copy of this section is provided in the image below.

In the CAPA procedure, we state that any risk score of 4 or 5 requires the implementation of a CAPA. If any of the escalation rules apply to the risk score, you should implement a CAPA regardless of the total risk score. This is our recommendation for a method of risk evaluation, but there is no standard telling you that you must do it this way. However, we believe this method of calculation is more likely to be consistent because it is based on the MDSAP grading guidelines.

If no escalation rules apply to your risk score, it may be possible to implement containment and corrections only. If your action plan includes only containment and corrections, we recommend that you monitor the quality issue as a process metric or quality objective to identify future occurrences. If you are evaluating a new CAPA that appears to have the same root cause as an existing CAPA, you may need to update the risk score of the existing CAPA to a higher number based on the escalation rules. Escalation may impact your corrective action plan, and it should certainly affect the prioritization of your existing CAPA.

Plan and document your corrective actions, including updating documentation (Step 5)

The biggest mistake you can make in this stage of the CAPA process is to spend too much time planning your corrective actions. “Take action and document it” is the essence of this step in the CAPA procedure. If you spend all of your time planning, then you will never take action. The CAPA plan can and should be edited. Therefore, if you know a procedure needs revision, start revising the procedure immediately. You can always add more corrective actions to your corrective action plan after you write the procedure, but you need to start writing. The second biggest mistake you can make during this stage is failing to document the actions you take. If you don’t document your actions, it’s a rumor, not a record.

Do your planned actions adversely affect regulatory compliance or safety and performance? (Step 6)

One of the required actions for a CAPA is to update your procedure(s) to reflect any process improvements to eliminate the root cause. When you update procedures, you need to make sure procedural changes do not create a regulatory compliance issue. We do this by inserting a cross-reference to each regulatory requirement in our procedures. The cross-reference is then color-coded and we add a symbol for people that are color blind. Symbols also facilitate electronic searches for regulatory requirements.

If corrective actions you implement involve design changes you will need to repeat design verification and design validation to make sure design changes do not impact safety and performance. If corrective actions change your manufacturing or service processes, you will need to repeat process validation to make sure that the process changes do not impact compliance with your design specifications. These recertification and revalidations steps are frequently forgotten, and they represent the biggest challenge for review and approval of design and process changes (described in the video below).

Perform an effectiveness check – Step 7 of your CAPA procedure

Most people verify CAPA effectiveness by verifying that all the actions planned were completed, but this is not a CAPA effectiveness check. An effectiveness check should use quantitative data from your investigation of the root cause as a benchmark. Then you should verify that the performance after corrective actions is implemented resulted in a decrease in the frequency of the quality problem, a decrease in the severity of the quality problem, or both. Ideally, a process re-validation was performed because validation protocols are required to include quantitative acceptance criteria for success.

Step 8 – Record your CAPA results

You are required to record each step of your CAPA procedure in a CAPA record (FRM-009). Therefore, we created a form that is organized in the order of the CAPA process, and then we wrote the CAPA procedure to match the organization of the form. The biggest mistake we see is that the CAPA owner does not update the record to include all of the details until the CAPA plan is completely implemented. This is a mistake. You should be documenting actions when they are taken. When you gather new information, and you need to update your root cause investigation or your corrective action plan, you are allowed to modify the record. You just need to have a system that allows you to keep track of revisions. This is often referred to as an “audit trail.” If you have a paper-based system, you will need to sign and date the document each time you make an addition. If you revise previous entries, you will need to revise and reprint the CAPA record, and then you will need to sign and date the revised and reprinted CAPA record. Ideally, you will have an electronic system with an audit trail, but software budgets are not infinite.

CAPA procedure step 9 – Close the CAPA record 

The last step in the CAPA procedure is to close your CAPA record. As with most quality system records, the person responsible for the process should review and approve each record for closure with a signature and date. If the person assigned to the CAPA left sections incomplete or made mistakes in completing the CAPA form, the person that made the mistake should be instructed to correct the mistake, identify that they made a correction, and identify the date of the correction. If a CAPA is not effective, then a cross-reference to the new CAPA that is opened should be documented in the older CAPA record.

CAPA Training

If you are interested in more training on CAPA, you might be interested in purchasing Medical Device Academy’s Risk-Based CAPA webinar. 99% of companies hold off on their training until a procedure is officially released as a controlled document. In my experience, however, these procedures seem to have a lot of revisions made immediately after the initial release. New users ask simple questions that identify sections of procedures that are unclear or were written out of sequence. Therefore, you should always conduct at least one training session with users prior to the final review and approval of a procedure. This will ensure that the final procedure is right the first time, and it will give those users some ownership of the new procedure.

After you train your initial group, and after you make the edits they recommended, ask those trainees to review and edit your changes to the procedure. Sometimes we don’t completely understand what someone is describing, and sometimes maybe only half-listening. Going back to those people to verify that you accurately interpreted their feedback is the most important step for ensuring that users accept your new procedure.

After you approve your new CAPA procedure, make sure everyone in your company is trained on the final version of the procedure. CAPA is a critical process (i.e., “the heart”) in your quality system. Everyone should understand it. You should also provide extra CAPA training for department managers, such as root cause analysis training because they will be responsible for implementing CAPAs assigned to their department. You can use this 7-step process for any procedure, but ensure you use it for the most important process of all—your corrective and preventive action process.
Thank you for reading to the end of this article. Spaz and I thank you for your support.

This webinar bundle includes our recall procedure for compliance with ISO 13485:2016, Clause 8.3.3, US FDA, Health Canada, and EU MDR / IVDR.

The recall procedure is now in its fifth draft of the procedure. The recall procedure meets the requirements for clause 8.3.3 of ISO 13485:2016 and 21 CFR 806 for conducting corrections and removals of products. This updated procedure also meets the requirements for an advisory notices procedure. Matthew Walker updated the procedure to include references to the applicable ISO 13485:2016 clauses, and he added color-coding with symbols to auditors identifying where the requirements for each ISO 13485 requirement are found. The procedure also explains where the requirements for monitoring and measurement of processes can be found for each process.

Which device markets does this recall procedure address?

1. USA
   • 21 CFR 7 – FDA Enforcement Policy
   • 21 CFR 806 – FDA Corrections and Removals
2. Canada
   • SOR 98/282, Sections 63-65 – Recalls
   • Health Canada Guidance to Recall of Medical Devices (GUI-0054)
3. Europe
   • MEDDEV 2.12/1 – Guidelines on Medical Devices Vigilance System
     • Field Safety Corrective Action (FSCA)
     • Field Safety Notice (FSN) Template
   • Regulation (EU) 2017/745 (MDR)
   • Regulation (EU) 2017/746 (IVDR)

There is a separate section specific to each medical device market. As with all of our procedures, you will receive access to free updates of the procedure with your original purchase. The procedure now includes the following content:

The two most common causes of recalls are mix-ups in labeling and failure to properly validate software updates. If you are interested in learning more about recalls and labeling, please see our webinar on recalls, labeling, and 21 CFR 820.120. If you would like to learn more about software validation, please consider purchasing our software validation procedure (SYS-044).

SYS-020 Recalls & Advisory Notices Procedure

Recalls and advisory notices procedure and webinar bundle. The webinar, procedure, and associated forms are available on-demand for download.

Price: $299.00

Please note: This product 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. 

When will the webinar be hosted?

The webinar was hosted on July 17, 2024, and the video is available on-demand for downloading anytime.

To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

This 513g submission webinar will give you step-by-step instructions for completing the FDA PreSTAR v1.0 template.

513g Submission Webinar Bundle ($149)

513(g) Templates & Webinar

The 513(g) templates are updated for use with the FDA PreSTAR v1.0 template, and the templates are bundled with a training webinar that explains how to complete the FDA PreSTAR v1.0 template. The folder also includes additional templates for devices where a De Novo submission is the anticipated regulatory pathway.

Price: $149.00

What you will learn in our 513g request webinar

This webinar was recorded on Friday, April 5, 2024. You can purchase it on-demand and watch the training as often as you wish. The webinar explains what a 513g request is, and when you should be submitting a 513g request within your overall design plan. The 513g request webinar reviews each of the content requirements in the FDA guidance document. The webinar includes a brief explanation of the requirements for obtaining a small business discount on the FDA user fee for a 513g request. Finally, you will learn about the FDA eCopy requirements for a 513g request.

What’s included with the 513g submission webinar bundle

The following templates and other documents are included with this webinar bundle. Several of the templates provided are only required for a De Novo submission. However, it is recommended to submit each of these documents as a draft if the anticipated regulatory pathway is a De Novo Classification Request.

• FDA PreSTAR v1.0 Template
• 513(g) Cover Letter
• Draft IFU Template
• Draft Label Template
• Risk Mitigation Table (required for De Novo)
• Alternative Procedures & Techniques (required for De Novo)
• Efforts to Identify Potential Predicate Device (required for De Novo)
• Classification Rationale as Class 1 or 2 (required for De Novo)
• Proposed FDA special controls (required for De Novo)
• Benefit-risk analysis considerations (required for De Novo)
• FDA Guidance for 513g Submissions
• Native Slide Deck (24 slides)
• Recording of the Presentation (April 5, 2024)

The presentation was 58 minutes in duration. All content deliveries will be sent via AWeber emails to confirmed subscribers.

Other resources

If you need additional help preparing a 513g submission, please review our blog on 513g submissions or schedule a call with a member of our team.

About Your Instructor

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

This webinar shows you how to recommend FDA special controls to address risks to safety and to ensure performance for a De Novo application.

What are your proposed FDA special controls for a De Novo? ($49)

This webinar will teach you how to propose appropriate FDA special controls for your subject device in a De Novo Classification Request. You might think that you need to read the FDA guidance on how to write a special controls guidance. However, the FDA no longer writes a Special Controls guidance document for new device regulations. Instead, the FDA includes the special controls directly in the new device regulations. The first part of the regulation identifies the regulation name and number. The second part of the regulation describes the intended use and describes the technological characteristics of devices in the scope of the new regulation. Finally, the last second lists the requirements for special controls. The purpose of those special controls is to verify and validate that each risk control recommended in the risk mitigation table for the new device regulation has been addressed.

What are your proposed FDA Special Controls for a De Novo?

This webinar will teach you how to propose appropriate FDA special controls for your subject device in a De Novo Classification Request. You might think that you need to read the FDA guidance on how to write a special controls guidance. However, the FDA no longer writes a Special Controls guidance document for new device regulations. Instead, the FDA includes the special controls directly in the new device regulations.

Price: $49.00

Please note: These products 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.

When is the FDA special controls webinar?

This webinar will be live on Thursday, July 25, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish. If you need help preparing your FDA eSTAR submission, we offer a standard fee for De Novo submissions or we can help you on an hourly basis. 

What you will receive in the FDA special controls webinar:

If you would like to upgrade your purchase to our entire 510(k) Course, which includes templates and webinars for pre-submissions, 513(g) Classification Requests, 510(k) submissions, and De Novo applications, please contact Lindsey Walker and she will provide you with a quote that includes a credit for your purchase of this webinar.

About Your Instructor

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. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

This webinar will teach you how to identify a potential predicate with a template that walks you step by step exactly through what we do.

Identifying a Potential Predicate Webinar ($79)

This webinar will teach you how to identify a potential predicate. We’ve done this before, but now we have a template that walks you step by step exactly through what we do. It shows you screen captures and gives you examples of exactly what we use in the FDA database and other proprietary databases to identify a predicate. You can use this for 510(k) submissions, and for De Novo submissions.

Identifying a Potential Predicate Webinar

This webinar will teach you how to identify a potential predicate. We've done this before, but now we have a template that walks you step by step exactly through what we do. It shows you screen captures and gives you examples of exactly what we use in the FDA database and other proprietary databases to identify a predicate. You can use this for 510(k) submissions, and for De Novo submissions.

Price: $79.00

Please note: These products 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.

When is the Identifying a Potential Predicate Webinar?

This webinar will be live on Thursday, July 18, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish. If you need help preparing your FDA eSTAR submission, we offer a standard fee for De Novo submissions or we can help you on an hourly basis. 

What you will receive in the Identifying a Potential Predicate Webinar:

If you would like to upgrade your purchase to our entire 510(k) Course, which includes templates and webinars for pre-submissions, 513(g) Classification Requests, 510(k) submissions, and De Novo applications, please contact Lindsey Walker and she will provide you with a quote that includes a credit for your purchase of this webinar.

About Your Instructor

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. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

In our benefit-risk analysis webinar, you will learn how to write a complete TMP-034 to include in your De Novo application.

Benefit-Risk Analysis Webinar ($79)

This webinar was specifically created for medical device companies that are preparing a De Novo application using the latest version of the FDA eSTAR. On page 9 of the FDA eSTAR you will need to attach a copy of your benefit-risk analysis. In this benefit-risk analysis webinar we will explain how to complete our template for a benefit-risk analysis so that you can include it in your De Novo application.

Benefit-Risk Analysis Webinar

This webinar explains how to conduct a risk-benefit analysis in accordance with ISO 14971:2019, Clause 7.4. The webinar references Medical Device Academy's procedure for risk management (SYS-010). The procedure is not included, but the benefit-risk analysis template (i.e., TMP-034) is included.

Price: $79.00

Please note: These products 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.

When is the Benefit-Risk Analysis Webinar?

This webinar was recorded on May 9, 2024. You can purchase it on-demand and watch the training as often as you wish. If you need help preparing your FDA eSTAR submission, we offer a standard fee for De Novo submissions or we can help you on an hourly basis. 

What you will receive in the Benefit-Risk Analysis Webinar:

• TMP-034, Benefit-Risk Analysis Template
• Recording of live webinar
• Native PowerPoint Slide Deck

If you would like to upgrade your purchase to our entire 510(k) Course, which includes templates and webinars for pre-submissions, 513(g) Classification Requests, 510(k) submissions, and De Novo applications, please contact Lindsey Walker and she will provide you with a quote that includes a credit for your purchase of this webinar.

About Your Instructor

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. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

In our classification rationale webinar, you will learn how to write a classification rationale for De Novo applications.

Classification Rationale Webinar ($49)

This webinar was specifically created for medical device companies that are preparing a De Novo application using the latest version of the FDA eSTAR. On page 7 of the FDA eSTAR you will need to select Class 1 or Class 2 (almost always Class 2 will be required). Then you will have to write a justification for the classification you chose. Class 1 devices only require General Controls (i.e., labeling), while Class 2 devices require Special Controls (e.g., biocompatibility testing, sterilization validation, software validation). In this webinar we will also recommend a simple method for writing a regulation name and identifying the most likely regulation number for your De Novo application.

Classification Rationale Webinar

This webinar was specifically created for medical device companies that are preparing a De Novo application using the latest version of the FDA eSTAR. On page 7 of the FDA eSTAR you will need to select Class 1 or Class 2 (almost always Class 2 will be required). Then you will have to write a justification for the classification you chose. Class 1 devices only require General Controls (i.e., labeling), while Class 2 devices require Special Controls (e.g., biocompatibility testing, sterilization validation, software validation). In this webinar we will also recommend a simple method for writing a regulation name and identifying the most likely regulation number for your De Novo application.

Price: $49.00

Please note: These products 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.

When is the Classification Rationale Webinar?

This webinar will be live on Thursday, July 11, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish. If you need help preparing your FDA eSTAR submission, we offer a standard fee for De Novo submissions or we can help you on an hourly basis. 

What you will receive in the Classification Rationale Webinar:

• Template for writing a Classification Rationale, Draft Regulation Name and Number
• Recording of live webinar
• Native PowerPoint Slide Deck
• Login Information (if purchased before Live Webinar)

If you would like to upgrade your purchase to our entire 510(k) Course, which includes templates and webinars for pre-submissions, 513(g) Classification Requests, 510(k) submissions, and De Novo applications, please contact Lindsey Walker and she will provide you with a quote that includes a credit for your purchase of this webinar.

About Your Instructor

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. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

Equipment maintenance is commonly forgotten during audits. Do you have a Facility, Plant and Equipment Maintenance Procedure (SYS-005)?

Facility, Plant, and Equipment Maintenance Procedure (SYS-005) and Webinar Bundle ($299)

SYS-005 Facility, Plant and Equipment Maintenance Procedure

SYS-005 Facility, Plant and Equipment Maintenance Procedure

Price: $299.00

To meet the requirements for ISO 13485:2016, Clause 6.3, you need a facility, plant, and equipment maintenance procedure. This is one of the most commonly forgotten quality system requirements by auditors, but why? There are several reasons. Maintenance is usually not included in your management reviews as an input unless your company is tracking compliance with your preventive maintenance schedule as a process metric. Another reason why auditors overlook maintenance is that they spent too much time in conference rooms and not enough time looking at the equipment and facilities. The third reason is that most companies have a reactive approach to maintenance instead of a proactive approach. Using similar approaches to equipment maintenance and calibration helps ensure that there is a routine monitoring of equipment, but auditors need training on the process approach to auditing.

What is included in the Facility, Plant, and Equipment Maintenance Procedure?

If you would like to ask specific questions about the facility, plant, and equipment maintenance procedure, please submit them via email or schedule a call using the calendar app on our contact us page. All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.

Please note: This product 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. 

 To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

About Your Instructor

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. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

The purpose of this calibration procedure is to control measuring and test equipment, to ensure that its accuracy and fitness for purpose.

Calibration Procedure SYS-016 and Webinar Bundle ($299)

SYS-016 Calibration Procedure

SYS-016 Control of Monitoring & Measurement Devices (i.e. Calibration) Procedure - This procedure covers all measuring and test equipment used within the scope of your quality management system, including product development and production. This procedure also includes validation and revalidation requirements for software used to control and monitor calibrated devices.

Price: $299.00

This calibration procedure covers all measuring and test equipment used within the scope of your company’s quality management system, including product development and production. The procedure has been updated to the requirements for ISO 13485:2016. References to EN ISO 10012:2007 were added for companies that have more technical questions regarding calibration requirements.

There is also a new section in the procedure that specifies the requirements for software validation of calibration management software. This requirement is stated in ISO 13485:2016, but this procedure includes a reference to ISO/TR 80002-2:2017. That standard includes an example specific to the validation of calibration software. If you are implementing quality system software, you might also be interested in purchasing our Software Tool Validation Procedure (SYS-051).

This is the primary document meeting the applicable regulatory requirements for Control of Monitoring and Measuring Devices, as defined in your company’s Quality System Manual (POL-001).

What is included with the Calibration Procedure:

Document control lists and forms are also included within this procedure. These documents are updated for the US FDA Quality System Regulation (QMSR), ISO 13485:2016, and the new European Regulations. The following is a list of documents included:

• SYS-016 Calibration Procedure – FDA 21 CFR 820.72
• LST-006 0.2 Equipment Register
• a recording of the webinar you can replay anytime
• the native slide deck for this webinar

If you would like to ask specific questions about the document control procedure and process, please submit them via email or schedule a call using the calendly app on our contact us page. All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.

Please note: This product 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. 

 To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

About Your Instructor

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. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

This quality system audits procedure is intended to meet the requirement for an internal auditing procedure in accordance with ISO 13485:2016, Clause 8.2.4 and 21 CFR 820.22.

Quality System Audits Procedure (SYS-021) Webinar Bundle

SYS-021 Quality Audits Procedure

SYS-021 Quality Audits Procedure - this includes a procedure, forms, and a webinar as a bundle.

Price: $299.00

When is the Webinar about this Quality System Audits Procedure?

This webinar was live on Monday, July 8, 2024. The webinar has been recorded. You can purchase it on-demand and watch the training as often as you wish. You will also receive access to updates free of charge with your purchase.

Please note: This product 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 (including your spam folder). The YouTube webinar above is outdated. The current list of content is listed below.

Quality System Audits Procedure Summary

This 10-page quality system audits procedure meets the requirements for clause 8.2.4 of ISO 13485:2016 and 21 CFR 820.22 for conducting internal quality system audits. The procedure is in its ninth draft, and the latest draft includes much more detail regarding methods for conducting an audit, the responsibilities of lead auditors and audit team members, and the requirements for auditor training, training effectiveness, and competency. The following forms and lists are associated with this procedure:

• FRM-034 Internal Audit Schedule (MS Excel)
• FRM-035 ISO 13485:2016 Clause Traceability Matrix (MS Word)
• FRM-043 Audit Report Review Checklist (MS Word)
• LST-007 Audit Log or Schedule (MS Excel)
• SYS-021 Quality Auditing Procedure Webinar (MS PPT)
• TMP-003 Supplier / Internal Audit Report Template (MS Word)
• TMP-035 Opening & Closing Meeting Checklist (MS Word)
• TMP-036 Opening Meeting and Closing Meeting Template (MS PPT)

This updated procedure may also be applied to remote auditing. However, a work instruction for remote auditing (WI-002) is sold separately as part of our remote auditing webinar. The section on auditor and lead auditor competency includes provisions for retrospective review of competency via recorded remote auditing. 

The procedure does not apply to supplier quality audits, which are managed through the Supplier Quality Management Procedure (SYS-011). However, the requirements for training, training effectiveness, and competency of 2nd party auditors are covered in the quality system audits procedure. The schedule for supplier quality audits may also be documented in the Audit Log (LST-007).

Cross-reference to audit criteria

This procedure was updated to include references to the applicable ISO 13485:2016 clauses, and color-coding was added by Matthew Walker to facilitate auditors identifying where the requirements for each sub-clause are found. The procedure also explains where the requirements for monitoring and measurement of processes can be found for each process.

Additional Quality System Audits Procedure Training

If you are interested in learning more about the process approach to auditing and adjacent link auditing, please see our webinar on the process approach to auditing.

To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

About Your Instructor

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. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.