Most pharmaceutical companies have an internal 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 pharma companies
under an FDA Warning Letter that have internal audit programs.
Why is this?
In my opinion, internal quality audit programs fail because:
1. Consideration is given only to the system in-place, not
whether the system complies with current industry practice and FDA expectations.
2. Auditors have been in the job too long and have
acclimated to what is in-place, not what should be in-place.
3. Auditors tread too lightly in politically sensitive areas.
4. Audit responses fall short of the true root cause,
particularly when it involves company culture.
5. Associated CAPAs are not effective, and repeated
observations are tolerated.
6. 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
Quality Management System (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.”
(Please see The QA Pharm 12/18/10.) 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 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 transfer out of the role nine months ago.
2. The planned versus executed supplier audits is behind for
critical suppliers 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 pharma. Lack of ownership and
accountability is endemic.
The QA Pharm
