Guidelines for CAPA Scoping

by William McQuillan, Jr CAPA Subject Matter Expert

Many organizations are diligent in identifying inputs to CAPAs and in meeting to review and approve the opening of a CAPA file. During the review process for opening a CAPA, it is important to evaluate the scope of the CAPA, if known. This activity is completed during the initial investigation phase and facilitates the docu-mentation of your organization’s due diligence related to issues escalating to CAPA.

Opening a CAPA in a timely manner is critically important to your organization. Evaluating the inputs to CAPA is equally important. While confirming all of one’s information, there is an additional thought that must be appropriately addressed. What is the scope of the problem that will be addressed? Scoping a CAPA correctly will increase the file owner’s ability to understand what issues must be addressed, and to know when success has been achieved. To facilitate answering this question, these follow up questions should be evaluated once the CAPA is opened and in the investigation phase.

Consider that the initial problem statement recorded should have answered the following questions:

o What happened?

o Where it happened?

o Who identified the issue?

o When did the issue first occur?

o Why did it occur (if known)?

Now that you are ready to investigate your organization’s newly opened CAPA, several issues must be considered:

o How many process or product areas are affected by the identified nonconformity?

o How many process or product-related areas could be affected by a similar issue due to design?

o What products are currently in development that may be affected by the results of the CAPA investigation?

o Is the issue supplier-related?

o Is there product in the field related to the issue?

o Is the issue related to another CAPA within your organization and should it be included within the scope of that CAPA file?

o What immediate actions has your organization taken to address the issue?

Answering these questions will provide a more accurate assessment of the CAPA scope and the resources/organizational partnerships that will be required to successfully complete a thorough investigation in a timely manner.

A challenge many organizations face when moving into the full investigational phase is how to ensure that appropriate resources will remain available through completion. CAPAs are essentially new projects that must have appropriate planning, resourcing and oversight. Assessing inputs and the initial finding using tools that most non-QA teams are accustomed to using, like project planning and analysis, will facilitate the level setting of expectations and understanding of potential obstacles that may arise during the scoping phase. I would strongly recommend a project kickoff meeting with the information gathered to ensure that all key individuals involved agree to the CAPA scope.

Key areas to highlight with the group of stakeholders are:

o Inputs to the system with the identified deficiency

o Customers of that system

o Processes that govern that system

o Expected outputs

Preparing the file to move into the next phase of investigation becomes much more efficient if all key individuals, internal and external to one’s organization, have been involved at the onset of the investigation, and scoping has been completed based on the initial data related to the creation of a CAPA.

About The Author

This is Will McQuillan’s second blog in a 13-part series on CAPA Implementation. Will McQuillan is a CAPA Subject Matter Expert, and former Global Manager Change Document and Record Management at Cordis, a Johnson & Johnson Company

He welcomes your feedback. His next blog, “CAPA Measurement Tools” will be published in November, 2009. Will’s CAPA-related topics he will publish on in the coming weeks include the following:

o Measurement Tools

o Investigation Tools

o CAPA Owner Guidance

o How to Present at Reviews

o CAPA Investigation Documentation

o Scope Verification

o Implementing Change

o Staying on Track

o Managing Obstacles

o Effectiveness Criteria Selection

o Tools for File Closure

His first blog, “When does an organization need to open a CAPA? (Identifying and Measuring Inputs to CAPA) can be accessed on the FDA Compliance Learning Community of enKap at http://www.enkap.com/profiles/blogs/when-does-an-organization-need

Will can be contacted at wmcquill@yahoo.com or at 510-207-0575

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