Internal Quality Audits: Valuable or False Security?

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

Tue, 02/08/2011 - 04:30

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.

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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.

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Comments

Submitted by hank783 on Tue, 02/08/2011 - 10:51

I have been teaching internal and lead auditor classes for over 15 years now and have always emphasised the need for auditors to have the organizational freedom to identify any and all weaknesses in the QMS.  Unfortuately the author is correct in his beliefs more often than not - even with the 3rd party audit process.

The old addage "Familiarity breeds contempt" can be applied here.  Probably the weakest part of the QMS audit process is the lack of preparation for the audit.  Auditors who are called upon from their regular job are not given enough time to prepare for the audit they are selected to conduct.  One way to minimize this problem is to schedule audits at least 6 months in advance and assign auditors to the task at this time.  This will allow them to plan and prepare well ahead if the process is well managed by the audit manager of the company.

One other thought comes to mind - perhaps the writers of ISO 13485 should rething the requirement for continual improvement that was deleted from the ISO 9001 portion of the standard when it was used as a foundation for 13485.

 

 

 

Submitted by hank783 on Tue, 02/08/2011 - 10:55

I have been teaching internal and lead auditor classes for over 15 years now and have always emphasised the need for auditors to have the organizational freedom to identify any and all weaknesses in the QMS.  Unfortuately the author is correct in his beliefs more often than not - even with the 3rd party audit process.

The old addage "Familiarity breeds contempt" can be applied here.  We do become too familiar with the processes and often do not keep an open mind to possible weaknesses in the system.

Probably the weakest part of the QMS audit process is the lack of preparation for the audit.  Auditors who are called upon from their regular job are not given enough time to prepare for the audit they are selected to conduct.  One way to minimize this problem is to schedule audits at least 6 months in advance and assign auditors to the task at this time.  This will allow them to plan and prepare well ahead if the process is well managed by the audit manager of the company.

One other thought comes to mind - perhaps the writers of ISO 13485 should rething the requirement for continual improvement that was deleted from the ISO 9001 portion of the standard when it was used as a foundation for 13485.

 

 

 

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