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The story easily becomes a case study on how different parts of the regulation support each other, and how compliance or personal responsibility for one section doesn't stop there – while the career-oriented individual needs to do his or her own job, they must also understand how other areas affect it – to the point of understanding how broadly and deeply to look for solutions to specific problems. 

The following story is not theory  -- it's career advice based on a specific case.

Corrective action/preventive action is a concept embodied in 21 CFR Part 820 (Good Manufacturing Practices, Quality System Regulation) as well as in ISO 13485:2003.

I visit (and audit) many medical device manufacturers.  Most are very knowledgeable about Corrective Action.  The purpose of Corrective Action is to collect and analyze information, to identify and investigate known product problems and known quality problems, and to take appropriate and effective corrective action and prevent the problem recurrence (meaning the manufacturer needs to take action so that the problem does not happen again).

Unfortunately, too often I see the same manufacturers struggle with the application of Preventive Action.  The purpose of Preventive Action is exactly that of Corrective action with very subtle yet distinct differences:  to collect and analyze information, to identify and investigate potential product problems and potential quality problems, and to take appropriate and effective preventive action in an effort to prevent these problems from occurring (that is, the manufacturer must prevent a failure).

The ultimate goal is continuous improvement focused on quality. To ensure effective corrective actions/preventive actions, the identification of failure incidence (actual or potential) is pivotal in identifying the actions undertaken.  These failure incidences are the records US FDA reviews during their investigation.  After all, corrective action/preventive action, next to Management Responsibility, is perhaps the most important process of the overall quality management system.

To achieve effective corrective action/preventive action process acuity, it is important to track, manage and assess different quality data points within the organization and to manage key interfaces throughout the quality management system. I recently audited a global medical devices company that is perhaps the world's second-largest producer of advanced wound management products.  While reviewing records for the control of nonconforming products I was able to effectively link to material control procedures and found a previously unrecognized potential problem.

The company’s procedures allow the use of nonconforming product.  This is not as unusual a practice as you might believe.  FDA takes such practices very seriously.  The regulations require a higher level of control when a company’s Material Review Board decides to use nonconforming product “as-is”. 

My client’s system requires each use “as-is” disposition to be documented, and an evaluation is performed to ensure that continued use of the nonconforming product does not compromise the safety and effectiveness of the finished device.  The company’s procedures were well defined and documented according to the requirements of 21 CFR 820.90, “Nonconforming Product”.  However, my next task was to review the implementation of this procedure before I could determine conformance to regulations.

I requested any analysis conducted on the frequency of use “as-is” dispositions.  The company stated the occurrence of use “as-is” dispositions is not an item trended with graphs or Pareto charts.  However, the company provided me with a hand-written line graph for the number of occurrences of this disposition over the past 6 months.  I randomly selected the disposition of use “as-is” occurring in July 2011 for review.

The company opened a nonconforming report for a particular component failing to meet dimensional specification on 20 July 2011.  The Material Review Board decided to use the components “as-is” on 21 July 2011.  The lot of defective components would not be sorted because all of the components had the same dimensional defect.  Rework was impossible without destroying the component.

The length of time from open to disposition was but one day and appeared to be an insufficient amount of time for conducting a proper evaluation to ensure use of the nonconforming material does not compromise safety or effectiveness. I learned the nonconforming materials were release for build into DEMONSTRATION devices only; these components were not to be built into devices intended to be used on patients.

I had found conformance; all regulatory requirements had been met.  I was satisfied with the implementation of the company’s procedure; however, I continued the audit by linking the use of nonconforming product to material control.  But why do this?

I remembered during our initial tour of the manufacturing operations the control of materials to production work-orders was through a KAN-BAN system, where components are ‘pulled’ from inventory when needed.  The system did not ‘push’ product to specific work-orders as would be required to ensure nonconforming product would only be used in DEMONSTRATION devices only.

I asked ‘what established procedures “push” nonconforming product accepted for use “as-is” to the appropriate work-order for DEMONSTRATION only units, so as to prevent inadvertent mix-up of this particular lot of nonconforming components with other lots of the same component that met specification?’

The company thought about my question for a brief moment and their Director responded that these special dispositions (use of nonconforming products) require ‘micro-management’ by key people to prevent any mix-up.  No other procedures were established.

While no specific evidence to support a noncompliance existed, I found the company failed to recognize a “potential problem” which could create a situation where nonconforming products are built into finished devices.  And as I think about it further, perhaps this company need to also review their compliance with 21 CFR 820.86, Acceptance Status.”

820.86 Acceptance status.  Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria.