Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

When establishing an audit program, QA typically audits quality control and manufacturing, however, which department audits QA functions.  In order for the auditor to be independent of the auditee we've utilized our regulatory team.  Has anyone had success with other departments auditing QA functions?

Hi Anon,

This thread is similar to a recent previous one. There are some companies which have only one QA/RA department. In this case it is even harder to achieve the independence.
Usually in large companies which have a strong independent R&D department, R&D and/or RA perform the audit.
Some companies have a distinct Compliance department. This could also work.

I've seen successful audits like that in the past. At the end of the day, it depends on the people

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Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
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Original Message:
Sent: 04-Jun-2020 15:51
From: Anonymous Member
Subject: Pharmaceutical auditing

This message was posted by a user wishing to remain anonymous

When establishing an audit program, QA typically audits quality control and manufacturing, however, which department audits QA functions.  In order for the auditor to be independent of the auditee we've utilized our regulatory team.  Has anyone had success with other departments auditing QA functions?

Hello,

To add on what Spyros said, you can train other individuals in the company to be internal auditors who then audit QA functions.  I worked for a small pharma company and we actually outsourced an external consultant to specifically do targeted internal audits to areas where QA were responsible so there was still the independence.  We had the external consultant come in once a year for two days to complete internal audits on internal audits (yea I know haha), quality inspections at incoming, quality inspections at final product, label review, etc.  They were basically auditing QA ensuring they were following procedures and documenting activities.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 05-Jun-2020 02:47
From: Spyros Drivelos
Subject: Pharmaceutical auditing

Hi Anon,

This thread is similar to a recent previous one. There are some companies which have only one QA/RA department. In this case it is even harder to achieve the independence.
Usually in large companies which have a strong independent R&D department, R&D and/or RA perform the audit.
Some companies have a distinct Compliance department. This could also work.

I've seen successful audits like that in the past. At the end of the day, it depends on the people

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 04-Jun-2020 15:51
From: Anonymous Member
Subject: Pharmaceutical auditing

This message was posted by a user wishing to remain anonymous

When establishing an audit program, QA typically audits quality control and manufacturing, however, which department audits QA functions.  In order for the auditor to be independent of the auditee we've utilized our regulatory team.  Has anyone had success with other departments auditing QA functions?

The people I have used in the past are in roles outside most QA such as a sales manager or accountant. In my opinion what you really need is someone with a forensic questioning ability and people skills - details of the standard and auditing SOP are then just a matter of training. I feel RA is too closely associated with QA under ISO 13485:2016 to be seen as independent.

I am a great believer in a fresh pair of eyes as you become used to anything if you see it everyday and have been know pick the awkward intern who asks the difficult question at a company meeting as a new auditor. My advice be creative - it is about the person: if they are creative, questioning and get on well with people ... they can audit anything with a bit of training, so cast your net wide!

Good luck

Neil

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Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom
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Original Message:
Sent: 04-Jun-2020 15:51
From: Anonymous Member
Subject: Pharmaceutical auditing

This message was posted by a user wishing to remain anonymous

When establishing an audit program, QA typically audits quality control and manufacturing, however, which department audits QA functions.  In order for the auditor to be independent of the auditee we've utilized our regulatory team.  Has anyone had success with other departments auditing QA functions?

Hi 
I have had great success managing the internal audit program. For QA functions, I have been using various approaches and different auditors independent of QA functions. The way to go is to use qualified auditors who are SMEs in their areas but are end users to QA functions. Example - GMP Document Control and Management, a QA function where there are several departments who are end users when it comes to issuance of batch records/protocols, SOP implementation, archival etc. So the end users such as production, packaging, QC, Validation, R&D, Materials Management, Engineering are the most informed personnel when it comes to QA Document control's functions. We have had success using the heads of departments (HoD) of these end users as the lead auditors.
Also this approach can be used for auditing other QA functions such as sampling, visual inspection, in-process checks, labeling issuance and control, retain samples management, vendor qualification program, change controls, investigations, CAPAs, batch record review / release, market complaint investigation, APRs, so on and so forth.
Some examples - A good auditor can be a production supervisor, maintenance engineer, laboratory supervisor, AR&D supervisor, Validation Sr. Chemist, Regulatory CMC Manager, Regulatory Labeling Manager, ECTD Manager, Regulatory Compliance Manager, Corporate Quality Audit Manager etc.

I hope this helps.

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Kaushal Shah
Sr. Manager - Corporate Quality Audit - Americas
East Windsor NJ
United States
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Original Message:
Sent: 04-Jun-2020 15:51
From: Anonymous Member
Subject: Pharmaceutical auditing

This message was posted by a user wishing to remain anonymous

When establishing an audit program, QA typically audits quality control and manufacturing, however, which department audits QA functions.  In order for the auditor to be independent of the auditee we've utilized our regulatory team.  Has anyone had success with other departments auditing QA functions?

If the audit function is not established in the company anyone in the company can audit. Note: The person who will audit needs to meet internal requirements for the auditor; auditor cannot audit the processes that he/she is responsible for.

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Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States
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Original Message:
Sent: 04-Jun-2020 15:51
From: Anonymous Member
Subject: Pharmaceutical auditing

This message was posted by a user wishing to remain anonymous

When establishing an audit program, QA typically audits quality control and manufacturing, however, which department audits QA functions.  In order for the auditor to be independent of the auditee we've utilized our regulatory team.  Has anyone had success with other departments auditing QA functions?