CAPA and P&PC: How to Handle These Two Medical Device Compliance Troublemakers

June 22, 2017

FDA QMS subsystems CAPA and P&PC

What can FDA’s data tell you? Sometimes you learn something new ‒ other times the data validates what you already know.

FDA’s CY 2016 Annual FDA Medical Device Quality System Data reveals that Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC) continue to cause compliance headaches for medical device manufacturers.

The data addresses findings related to five quality system subsystem areas: Corrective and Preventive Action (CAPA), Production and Process Controls (P&PC), Management Controls (MGMT), Design Controls (DES), and Document Controls (DOC). CAPA and P&PC together generated 66% of the 3,027 Form 483 observations in 2016, while the three other subsystem areas combined totaled 34%. For 2016, FDA reported 594 warning letter citations across the five subsystem areas. CAPA and P&PC combined were the source of 68% of those citations.

These results should prompt a thorough reassessment of your CAPA and P&PC processes. It’s easy to gloss over “routine” areas and assume they are under control, but the FDA findings show otherwise.

Troublemaker 1: CAPA

The Top Three CAPA-Related Domestic 483 Observations in 2016

  • 33% 820.100(a) Corrective and preventive action.
  • 28% 820.198(a) Complaint files.
  • 14% 820.90(a) Nonconforming product. Control of nonconforming product.
    (from the total number of 710 domestic observations related to CAPA)

Most of the observations addressed CAPA – but more than one out of four observations were associated with complaint files.

The same pattern is visible in the CAPA-related warning letter citations below. CAPA again is the top source, and complaint files is in the second spot.

Top Sources of CAPA-Related Domestic Warning Letter Citations in 2016

  • 27% 820.100(a) Corrective and preventive action.
  • 19% 820.198(a) Complaint files.
  • 12% 820.90(a) Nonconforming product. Control of nonconforming product.
  • 7% 820.198(c) Complaint files.
  • 7% 820.20(c) Management responsibility. Management review.
    (from the 59 domestic observations related to CAPA)

Recommendation: A Focused CAPA Review Checklist

Ideally, your management review process would have already alerted you to any inadequacies with your CAPA and complaint management systems, through internal audit observations, late MDRs, aging CAPAs and complaints, or having no CAPAs being generated at all. However, to test the robustness of your program, FDA’s CAPA data provide a good starting point for designing a focused review checklist.

We encourage you to examine your CAPA and complaint-handling processes sooner rather than later so that your company isn’t added to the 483/warning letter list.

Troublemaker 2: P&PC

The P&PC-related findings from the 2016 Annual FDA Medical Device Quality System Data differ from the CAPA findings in that there are no obvious “hot spots” to address. For example, in the list of warning letter citations below, the results are spread more evenly among the top five sources, ranging from 13% to 7% each.

Top Sources of P&PC-Related Domestic Warning Letter Citations in 2016

  • 13% 820.50 Purchasing controls.
  • 13% 820.75(a) Process validation.
  • 11% 820.80(d) Receiving, in-process, and finished device acceptance. Final acceptance activities.
  • 9% 820.72(a) Inspection, measuring, and test equipment. Control of inspection, measuring, and test equipment.
  • 7% 820.80(a) Receiving, in-process, and finished device acceptance. General.
    (from the 55 domestic observations related to P&PC)

For the P&PC subsystem-related warning letter citations, the top five sources comprised 53% of the total. Seventeen different sections combined to form the remaining 47%, showing the broad range of areas that cause issues with P&PC.

Both purchasing controls and process validation appear at the top of the warning letter citations and the 483 observations, as seen below.

The Top Three P&PC-Related Domestic 483 Observations in 2016

  • 15% 820.50 Purchasing controls.
  • 13% 820.75(a) Process validation.
  • 7% 820.72(a) Inspection, measuring, and test equipment. Control of inspection, measuring, and test equipment.
    (from the 650 domestic observations related to P&PC)

Recommendation: Focus on Purchasing Controls and Process Validation

Basic, high-impact actions that can improve purchasing controls and process validation include:

Reexamine the purpose of process validation and improve your existing process. Many of the FDA findings related to process validation address understanding when and how to validate processes. Essentially, process validation is required when we cannot verify every product being manufactured. Verification performed by testing 100% of the products produced certainly gives us confidence in the product, but the power of process validation lies in having confidence in the process, so we do not have to test every product.

Strengthen your supplier management. Supplier controls, within purchasing controls, is a key area of FDA concern. Effective supply chain management is critical to maintain the availability and quality of your products.

Supplier-related activities to review include how your organization:

  • Identifies product and quality requirements.
  • Assesses the ability of potential vendors to meet organizational requirements.
  • Creates and maintains an approved supplier lists.
  • Uses a risk-based approach for vendor qualification and management.
  • Conducts vendor audits.
  • Resolves vendor issues.

We urge you to pay special attention to process validation and supplier management as you assess your P&PC compliance.

Data source: 2016 Annual FDA Medical Device Quality System Data. For the full FDA report, click here.

Need help taming these troublemakers?

Oriel STAT A MATRIX offers consulting related to FDA quality system compliance and related training, including courses on CAPA, process validation, and complaint handling.

Our team is here to help. Call 1.800.472.6477 or contact us online ›