Vendor/Supplier Audit

Vendor and supplier are used as synonyms.

Purpose

The purpose of the vendor audit is for the purchaser to check if:

The vendor has a quality system
The vendor follows his quality system
If the quality system is adequate for the purchaser

While the first two are relatively easy to check, the third requires a bit more experience as well as a good knowledge of quality systems and understanding that they may achieve the same even if they are different from what the auditor is used to.

Preparations

Agree with the vendor when you shall come. A surprise visit is never a good experience for anyone. Create your checklist for what you want to check, but never send it to the vendor before you arrive. The checklist may be based on requirements in ISO 90003 (Previously called ISO 9000-3) www.iso.ch or on the vendor audit checklist in GAMP4 or GAMP5 www.ispe.org or just created by yourself. Make sure that your own requirements are on the lists.

The audit

You are the auditor, and you lead the audit, even if this is the vendor's premises. The vendor has been told that he shall spend one hour explaining the quality system, and that you are not interested in knowing why you shall buy his system during that hour. The actual audit is when you ask for documentation to see what they do, and that they do what they claim. Ask questions starting with "Why", "How", "Show me" instead of questions that may be answered with yes or no. It is important that you follow the flow and understand whyat they are doing, rather than follow the checklists. Take a look at the checklist occationally only, to see that you have covered the topics you had on the list. When you have seen what you want, the audit ends with a "wash-up meeting" where all findings are discussed.The findings shall be objective, i.e. they shall be proved as missing, erronious and inadequate according to the quality system or expectations, and acknowledged by both parties. A report is created after the meeting, and shall contain what was discussed during the wash-up meeting only.