Risk Based Internal Auditing - Pharmaceutical Plants

Ajit Basrur

Leader
Admin
We have 6 Pharmaceutical plants and as per the existing practice, Internal Audits are done twice per year. For each time, 3 auditors inspect for 5 mandays irrespective of the plant size.

Going forward, I would like to adopt a Risk based approach based on type of formulation, Volumes handled, total product mix etc.

Does any one have experience on this ? Any ideas towards implementation of this concept are most appreciated :)
 

Sidney Vianna

Post Responsibly
Leader
Admin
Re: Risk based Internal Auditing

We have 6 Pharmaceutical plants and as per the existing practice, Internal Audits are done twice per year. For each time, 3 auditors inspect for 5 mandays irrespective of the plant size.

Going forward, I would like to adopt a Risk based approach based on type of formulation, Volumes handled, total product mix etc.

Does any one have experience on this ? Any ideas towards implementation of this concept are most appreciated :)
I wholeheartedly support the concept which leads to appropriate usage of audit resources. My suggestions to you are:
1. Do not be overly concerned with a risk quantification criteria, but do have a criteria.
2. Use not only past performance, but future considerations to assess risk. For example, one of the plants would be used to introduce a brand new product, with new production equipment being deployed.
3. Dialogue with the regulatory authorities (if any) overseeing the plants to make sure they buy into your concept before you implement it.
4. Be flexible to deviate from a published audit schedule, should circumstances indicate something out of the ordinary is happening.
5. Make sure the language of risk is also used when reporting results to site and top management. Report perceived and tangible gains accordingly so they buy in to the concept.
 
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