Client Audit Question - Entitled to see all of our documents in an audit?

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sniderdi

I am new to this forum, so please be gentle with me :D. So, I started a new company, I come from Source Materials in the pharma background so audits, and the processes were very clear cut. I work for a company that we build customer refrigeration/freezer units, our biggest clients are plasma centers, so that throws us into the pharma world. We have 3 different plasma companies that we build and validate freezers for. One of our clients have tried telling our manager that they are entitled to see all of our documents in an audit, and I know this is not true but need to be able to back that up in our next audit. I know they are entitled to see our general documents, but we have client specific documents, and they should not be allowed to see their competitor's documents. Can someone please tell me if there is a specific regulatory guideline that backs this up and if there is a document we can have them sign that says they may not see other client documents? Anything would be great.
 

shimonv

Trusted Information Resource
Hi sniderdi,
The standards and applicable regulations focus on Safety and Effectiveness; I don't think they will help you much with a 'greedy' client.

You probably have a business agreement with the other clients that includes a confidentiality section. Based on that you cannot disclose propriety records.

Perhaps with other clients you are working according to their procedures and using their forms. If that's the case, then auditing their records is not even relevant..

You can point out that all records have been audited by a third party certification organisation (ISO 9001 and the likes), and maybe volunteer the external audit report.

Your client should be content with reviewing your quality system and records relating to the control of their product.

Hope it helps a little.
Shimon
 

Sidney Vianna

Post Responsibly
Leader
Admin
One of our clients have tried telling our manager that they are entitled to see all of our documents in an audit, and I know this is not true but need to be able to back that up in our next audit.
Welcome to The Cove. It might be a misunderstanding. The auditor might have meant all system documents. Obviously, they are not entitled to have access to documents that are sensitive in nature and outside of the scope of their audits. Just remind them that they would not like to see their proprietary information disclosed, and, accordingly, you must NOT provide access to their competitor's proprietary data either.
 

Golfman25

Trusted Information Resource
It's all relevant documents, not all documents. Proprietary trade secrets and customer confidential docs would not included. The auditor can pound sand if he doesn't like it. Probably wont affect your company with the higher ups.
 
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sniderdi

Thank you so much, it does. It backs up what I have been telling the office manager. These clients have really taken advantage of the fact that she doesn't know much about this arena. I worked for a drug manufacture and we had several huge clients we filled drug products for and I know they were only entitled to see general quality documents and processes that were client specific to them only.
 
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