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8 Steps to Writing an Effective CAPA Procedure – The Best of Blogs

Best of blogs 8 Steps to Writing an Effective CAPA Procedure   The Best of Blogs

8 Steps to Writing an Effective CAPA Procedure is the first in the “The Best Of” Medical Device Academy’s previously published blogs. We’re republishing these blogs due to tremendous popularity and response from our readership. In this blog, Rob Packard provides a list of 8 steps to writing a more effective CAPA procedure, proper implementation, creating a CAPA process flow chart, training, etc.

CAPA Procedure Image7 8 Steps to Writing an Effective CAPA Procedure   The Best of Blogs

The author provides a list of 8 steps to writing a more effective CAPA procedure, proper implementation, creating a CAPA process flow chart, training, etc.

During a recent internal audit I was performing for a new client, I noticed that they were not meeting one of the requirements of their CAPA procedure. Specifically, the procedure indicated that all CAPA plans must be written within seven calendar days of initiating the CAPA. Despite this requirement in their procedure, the client was indicating that CAPA plans were due within 30 calendar days on their CAPA form (http://bit.ly/CAPAForm).

This example is a minor nonconformity, but the reason why this client was not following their procedure is more interesting. The procedure was 100% compliant with FDA regulations (http://bit.ly/21CFR820100), but the procedure did not match how the company performed the process. The procedure and the process MUST match.

This client purchased their CAPA procedure from a consultant, changed the title, and had everyone in the company “read and understand” the procedure for training. If this sounds like your company, I’m not surprised, because this is not uncommon.

To avoid the mistakes this client made, follow the steps below for writing your own CAPA procedure:

8 Steps for Writing an Effective CAPA Procedure

  1. Create a CAPA process flow chart first
  2. Organize the layout of your CAPA form to match the process flow chart
  3. Write a procedure that follows the process flow chart
  4. Add references to the process flow chart for each section of the procedure
  5. Conduct group CAPA training using the draft version of your flow chart, form and procedure
  6. Make revisions to the procedure to clarify steps the trainees had difficulty with
  7. Ask the trainees to review the revised procedure and comment/edit
  8. Make final revisions and route the procedure for approval8 steps capa 8 Steps to Writing an Effective CAPA Procedure   The Best of Blogs

The specific order of steps is important to creating a CAPA procedure—or any procedure. Process flow charts help people understand the input, outputs and tasks within a process. Flow charts are also used by auditors to plan process audits (http://bit.ly/AdjacentLinkAuditing).

Most important of all, it’s very easy to create a form that is missing a step, but it is less likely to be missing a step if you create the flow chart first. [The flow chart example provided was created by Brigid Glass (http://bit.ly/BrigidGlass). Please connect with Brigid, or send her an email (brigid.glass@brigidglassassociates.net) and tell her thank you.]

Implementation

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. Authors should use outline formats that match the process flow and the form used exactly. There should be nothing extra in the procedure and nothing left out. 

Training

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 final review and approval of a procedure. This will ensure that the final procedure is correct the first time, and it will give those users some ownership in 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 may be 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 the procedure, make sure everyone in your company is trained on the final version of the CAPA procedure. CAPA is a critical process in your quality system. Everyone should understand it. You should also provide extra CAPA training for department managers, such as root cause analysis training (http://bit.ly/RootCauseTraining), because they will be responsible for implementing CAPAs assigned to their department.

You can use this 8-step process for any procedure, but ensure you use it for the most important process of all—CAPA.

If you are interested in more information on conducting effective CAPAs, please see our How to Improve Your CAPA Process Toolkit.

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Effective Management Solutions for 10 CAPA Program Blunders

The author provides effective management solutions for 10 real-life CAPA program blunders., (i.e., procedures, root cause analysis, closing CAPAs, etc.)

%name Effective Management Solutions for 10 CAPA Program Blunders

Effective Management Solutions for 10 CAPA Program Blunders

I am always looking for new and creative ways to help people understand the importance of maintaining an effective Corrective and Preventive Action (CAPA) program. If my last dozen CAPA blogs were not convincing enough, maybe this list of suggestions will help.

  • 1. If someone doesn’t follow procedures, just fire them. The employee in question is obviously the root cause. Management cannot be held responsible for the actions of employees. Once, I read a corrective action plan that indicated termination was the correction for a missing training record. The QA Manager clarified this statement by saying that the employee resigned for personal reasons, and there was no opportunity to train the employee. The CAPA record also indicated that 100% of the training records for manufacturing employees were reviewed for completion. There were a few records identified as incomplete, and those employees were trained—not terminated. The company also implemented a tracking tool to monitor training records. As a general rule, termination is not an acceptable corrective action or correction.
  • 2. If CAPAs are open longer than your procedure allows, close the existing CAPAs the day before the CAPAs become overdue, and open new CAPAs. CAPAs are not “closed” until all nonconformities have been corrected, corrective and preventive actions are implemented, and effectiveness checks are done. If the corrective and preventive actions were not completely effective, some companies chose to reopen the record and expand the plan of corrective and/or preventive actions. Other companies chose to open a new CAPA record, and reference the new record in the effectiveness check section of the previous CAPA record. Either approach works, but you cannot close an incomplete record and remain compliant.
  • 3. To verify effectiveness of corrective actions, just include a copy of your document change order. Documenting changes to procedures meets part of the CAPA requirements, but this verifies implementation—not effectiveness. In order to verify effectiveness, you need to verify that a nonconformity, or a potential nonconformity, will not recur. Low frequency defects are often hard to directly demonstrate. The best approach is to validate the process parameters to demonstrate quantitatively that the process capability has improved. For manual processes, you may need to test the new process to verify that the error will not occur, or will be detected.
  • 4. If you can’t finish tasks on schedule, revise your plan. If you still can’t finish tasks on schedule, revise your plan again—and again. It’s appropriate to revise your plan if you discover additional causes that your initial investigation missed. You should not, however, be revising target completion dates—except in rare cases. You also should not need to revise your plan multiple times.
  • 5. When you’re unsure why a problem occurred, identify the root cause as an unclear procedure and make a minor change to the appropriate SOP. Making changes to procedures is quick and easy to verify. Unfortunately, this approach is seldom effective at preventing recurrence. You need to develop new process controls to make errors impossible. Eliminate variation in raw materials, eliminate subjectivity in inspections and provide tools and fixtures to make manual processes capable of more consistent results. After you have reduced all three of these sources for process defects, then you are ready to revise your procedures and retrain employees.
  • 6. Whenever an employee fails to follow a procedure, just change the procedure to require another person to verify that they did it right. If one employee fails to follow procedures 100% of the time, a second person manually inspecting will also not be 100% effective. Another method of process control should be used to ensure that your process results in conforming product. Adding more people provides a false sense of confidence. The use of objective measurement and go/no go fixtures provides a higher degree of certainty.
  • 7. Write a justification for extension of the implementation timeline if a CAPA is about to become overdue. Justifications for extension provide objective evidence that management is aware that a CAPA plan is not meeting the target completion times. This is necessary on rare occasions, but extensions should never become routine. Also, if the progress of a CAPA is slow, monitoring should be frequent enough that management can release additional resources, or re-prioritize assignments in order to catch-up with the target completion date.
  • 8. Use the “5 Why” technique for root cause analysis to identify a user error to blame for complaints. The “5 Why” technique is effective at investigating the depth of a problem to ensure that the root cause is identified—instead of a symptom. If the reason for a problem is identified as a supplier, then it is necessary to ask why the supplier’s error was not prevented or detected. Sometimes this requires asking “Why” more than five times, but identifying a cause you have no control over will fix nothing
  • 9. To monitor your CAPA program, conduct weekly CAPA board meetings where a person is asked to explain why the CAPA they were assigned is overdue. Anyone can make an excuse, but excuses will not complete CAPAs. CAPA boards and weekly meetings can be extremely valuable, but your CAPA board should rely on three rules: 1. Managers need to be present in order to re-allocate resources and re-prioritize tasks. 2. CAPAs that are on schedule or ahead of schedule require no further discussion. 3. Anyone assigned to a CAPA that is behind schedule should request help and suggest solutions prior to the CAPA becoming overdue.
  • 10. Do not assign other departments the responsibility for CAPAs, because only QA has the training and competency to conduct an investigation of root cause, and write a CAPA plan.  One of the most effective CAPA management tools I observed was a visual communication board that used color coded paperclips which identified resources assigned to CAPAs. By limiting the number of paperclips to equal the number of resources allocated to CAPAs, that company was able to level the workload of CAPA assignments to match the available resources in each department. You can only achieve this level of efficiency and effectiveness if multiple people in multiple departments are trained and competent to investigate root cause and write CAPA plans. CAPA should be a core competency for every department, because it’s the best process for fixing and preventing problems.

Disclaimer: If you missed my sarcasm, these are ten ways to mis-manage a CAPA program. The brief paragraph after each numbered example is intended to provide the actual recommendation for effective management of your CAPA program.

%name Effective Management Solutions for 10 CAPA Program BlundersIf you are interested in learning more about CAPA, please register for the Medical Device Academy’s CAPA Workshop on October 3 in San Diego. Click here to register for the event: http://bit.ly/MDAWorkshops.

Posted in: CAPA

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Where to Locate Preventive Action Sources

%name Where to Locate Preventive Action Sources

The author discusses why preventive action is important in developing a sustainable and robust quality system and where to locate preventive action sources.

Most ISO auditors and FDA inspectors view CAPA as one of the most important processes in your quality system, but the approach to preventive actions is distinctly different between the ISO Quality System Standards (i.e., – ISO 9001 and ISO 13485) and FDA regulations (i.e., – 21 CFR 820.100). Throughout the FDA QSR, corrective action and preventive action are always found together, while in the ISO Standards, preventive action is a separate clause (i.e., – Clause 8.5.3). The wording of the two clauses is nearly identical, but ISO certification auditors tend to be purists. Therefore, your ISO certification auditor will expect you to have at least some examples of CAPAs that are 100% preventive. In fact, many auditors will issue a nonconformity if you have no examples that are 100% preventive.

Why is Preventive Action Important?

While I was conducting certification audits, I noticed that the better quality systems tended to have several examples of preventive actions. There were a few companies that actually had more preventive actions than corrective actions, and the quality systems at those companies happened to be much stronger in general—not just their CAPA process. Is this a coincidence?

No, the CAPA process is how you correct and prevent quality problems. In order to find preventive actions you actually have to develop your other quality system processes. These companies have strategically chosen to develop their quality systems to a higher level of performance, because they know that preventing quality problems results will cost substantially less than waiting until problems occur, and then fixing those problems. These companies often talk about the “Cost of Quality,” and when you tour their facility, you see quality objectives being communicated to everyone.

I have only had a couple of clients in the past decade that argued about the importance of preventive actions, but most clients ask me, “Where can we find more?”

Guidance Documents

As a certification auditor, I was not allowed to “consult,” but was able to mention guidance documents that might help. Therefore, the number one guidance document I recommend is 13485 Plus (a document sold by the Canadian Standards Association – http://bit.ly/ShopCSA).

13485 Plus includes all Clauses of the 13485 Standard, including text from ISO 14969—an international guidance document for the implementation of ISO 13485. In section 8.5.3 of the guidance document, you will find the following list of preventive action sources:

  1. Purchased product rejected on receipt
  2. Evidence that previous decisions affecting product conformity were false
  3. Products requiring rework
  4. In-process problems, wastage levels
  5. Final inspection failures
  6. Customer feedback,
  7. Warranty claims,
  8. Process measurements,
  9. Statistical process control documents,
  10. Identification of results that are out-of-trend, but not out-of-specification,
  11. Difficulties with suppliers,
  12. Service reports, and
  13. Need for concessions.
Practical Experience

In addition to the sources listed in guidance documents, there are three other sources that I personally recommend to consulting clients. One source is your internal audit process. Auditors verify conformity of processes, but internal auditors should also look for processes that are inefficient and need improvement. When auditors are performing a process audit, some process owners have difficulty identifying process metrics that are being tracked for each process. Auditors should be trained to follow the audit trail when there is an absence of process monitoring, because processes that are not already measured usually have more room for improvement than processes currently being measured.

Another source of preventive actions is the Total Product Lifecycle Database on the FDA website (http://bit.ly/FDATPLC). Every three-letter product code has a corresponding database report that you can use to identify product malfunctions and adverse events associated with competitor products. Learning from the mistakes of your competitors and implementing appropriate preventive actions internally is a great way to avoid the need for corrective actions—especially for design malfunctions.

The most fruitful source of preventive actions, however, is data analysis of process control monitoring. This source can identify negative trends within your company’s manufacturing process and suppliers’ processes. Catching a negative trend before products and components are nonconforming reduces the number of corrective actions needed, cost of scrap or rework, and eliminates delays that result in customer complaints.

Setting a CAPA Quality Objective

As your company begins to develop additional sources of preventive actions, you may want to consider establishing a Quality Objective for your CAPA process. The most common Quality Objectives for a CAPA process are:

  1. Initiate at least one new preventive action per quarter
  2. Close all CAPAs within 90 days
  3. Reduce the average aging of CAPAs to <45 days

However, I would like to suggest another possible Quality Objective:

  1. Increase the ratio of preventive actions to corrective actions to > 1.00

To be successful in achieving this Quality Objective, you will need to increase your preventive actions and decrease the number of corrective actions. Reduction of corrective actions indicates that you are identifying potential problems before a corrective action is required, while the increase in preventive actions indicates that your process for identifying potential problems is becoming more effective.

%name Where to Locate Preventive Action Sources

If you are interested in learning more about preventive action, please register for the Medical Device Academy’s CAPA Workshop on September 9 in Orlando, or on October 3 in San Diego. Click here to register for the event: http://bit.ly/MDAWorkshops.

Posted in: CAPA

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