Internal Quality Audits: Valuable or False Security?

Only when the “auditor” supports the “owner” by assessing whether the “ownership behaviors” are effective

Published: Tuesday, February 8, 2011 - 05:30

Most pharmaceutical companies have an internal current good manufacturing practices’ (CGMP) auditing program administered at the site and corporate levels of the organization. Auditors are typically part of the quality assurance or regulatory compliance function, and the usual approach is to examine the data trail to determine whether company policies and procedures are followed.

But is this enough to tell you what you really need to know about the state of your quality management system (QMS)?

In my opinion—no. After all, there are many pharmaceutical companies under a Food and Drug Administration (FDA) Warning Letter that have internal audit programs.

Why is this?

In my opinion, internal quality audit programs fail because:

• Consideration is given only to the system in place, not whether the system complies with current industry practice and FDA expectations.
• Auditors have been in the job too long and have acclimated to what is in place, not what should be in place.
• Auditors tread too lightly in politically sensitive areas.
• Audit responses fall short of the true root cause, particularly when it involves company culture.
• Associated corrective and preventive action (CAPA) procedures are not effective, and repeated observations are tolerated.
• Senior management does not adequately support the audit program as a priority.

I truly believe that the internal auditing process has tremendous potential to serve the organization. However, the internal auditing program and its auditors need to step out of their classic methodology and venture into new ways of adding value to the company.

In my opinion, a powerhouse for ensuring an effective QMS would be created if internal quality auditors were to compliment the QMS “ownership” concept.

I won’t repeat myself here about quality system ownership. (See “Who Owns the Quality System: Everybody, Somebody or Nobody?”) Suffice it to say that the independent role of the auditor assessing whether the features of quality system ownership are present and effective would add much more value to the organization.

Rather than publishing a list of typical observations, auditors would assess the strength of the backbone of the compliance sustainability strategy—“ownership and accountability.”
Thus audit observations—for a supplier quality system, as an example—would read more like:

1. Ownership for the supplier quality system has not been established since Bob Bagadonuts was transferred out of the role nine months ago.
2. The planned vs. executed supplier audit is behind for critical supplier's by six audits. This metric was presented at the management review, but no action was indicated.
3. The quality performance metrics for the supplier quality system indicate an upward trend in the number of suppliers with overdue audit responses. This metric has not been reported to the quality council as required by the management review procedure.
4. Employees in the incoming inspection department have not been trained on the supplier quality audit procedure as required by their training curriculum. A role is defined for incoming inspection personnel in the supplier quality procedure.

Get the idea? The “auditor” supports the “owner” by assessing whether the “ownership behaviors” are effective.

The result is an audit report that not only points to the compliance issues, but also reflects on the state of ownership and accountability.

We really need this in the pharmaceutical industry. Lack of ownership and accountability is endemic.

About The Author

The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).