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7.4 Purchasing
7.4.2 Purchasing Information
You must describe the product to be purchased and include where appropriate requirements for:
a)approval of product, procedures, processes and equipment
b)qualification of personnel
c)quality management system
You must ensure the adequacy of specified purchase requirements before communicating them to the supplier
Key Explanation Points and Tips:
ÞYour purchase documents (purchase order, contract, blanket order, your organization’s supplier quality manual, etc.) must specify your requirements for the purchased product; the suppliers QMS and any other initial or on-going controls you deem necessary for ensuring consistent supplier performance.
ÞYou must define how you ensure the adequacy of these documents before you communicate them to your supplier. A review of adequacy of purchasing documents may include their completeness, accuracy, correctness, quantity, timing, cost, approval, etc., by one or more functions; computerized controls, etc.
ÞIn larger organizations, this may be a separate process on-site or off-site. In either case, it must be identified and controlled as per clause 4.1 along with 7.4.2.
ÞWhile clause 7.4.2 does not specify keeping of records, you must show evidence of carrying out (issue purchase documents) and review of these documents (see clause 7.1d and 4.2.4 first sentence).
7.4.3 Verification of Purchased Product
Establish and implement inspection or other activities necessary to ensure that purchased product meets specified purchase requirements
For any verification at supplier premises (by your organization or customer), state in the purchasing information:
§ Your intended verification arrangements
§ and method of product release
Key Explanation Points and Tips:
ÞVerification of purchased product can range from doing no verification to 100% verification. You have flexibility in determining the scope of purchased product verification.
As indicated earlier in 7.4.1, you can apply different controls for different suppliers and products depending on your initial supplier evaluation and their ongoing product quality and delivery performance. In any case these controls must be included or referenced in your quality or inspection plans.
ÞTo the extent that you decide to do verification of purchased product, you also have flexibility in when you do the verification. You can do it on receipt or at any time prior to use in production. Make sure you appropriately control un-inspected product. This may include identification and storage to prevent unintended use.
ÞConsider using supplier quality plans, inspection plans, etc., to verify that purchased product meets specified purchase (product and QMS) requirements.
ÞYour inspection process must define and document the acceptance criteria and sampling plan for product conformity and what measurement tools needed. and records needed to show effective control of purchased product quality and supplier performance.
