some hints for QMS audit -3[分享]

4.3 Contract Review

　

4.3.1 General

[]Does the quality manual contain regulations for the contract review[/]

Yes - Section 4.3 with additional detail in the Contract Review flow chart.

[]Is the coordination of the activities of involved organizational units defined[/]

Company X Chemicals is a small company and as such the Vice-President of Operations coordinates contract review including determining who must be involved as appropriate to the contract requirements. This includes whether or not specific meeting(s) are necessary other than general interaction on a day-by-day basis.

4.3.2 Review

[]Are the correct definition of requirements and capability to meet contractual requirements being reviewed before[/]

Submission of a tender

Acceptance of a contract or order?
This applies to, for example, product requirements, equipment, fixtures, resources, skills, qualification of personnel, purchased products, quality inspections.

Because of the nature of the business as well as the nature of the products (and their intended use), a contract review is not always documented. Contract Review is documented only when a 'non-standard' Request for Quote is received. If 5 companies are buying cleaner 101, for example, a full-blown contract review is not seen as necessary or of value.

Typically a Request for Quote is in the form of a FAX and may be a voice telephone call. The Vice-President of Operations reviews each contract prior to acceptance, however if the request is for a standard product the main basis for review is pricing. However, once a contract is approved by the VP of Op follow on orders from the same company for the same product are not reviewed again unless a change in product occurs.

[]Is there a differentiation between[/]

Standard products

Standard products are those for which there is an existing formula (design).

Special products (if relevant)?

There are no 'special products' in our business. Not relevant.

[]Are quotations (tender) and contract or order compared before confirming the order[/]

The Vice-President of Operations compares quotations to orders when appropriate. For the most part orders are for product by product name/number without an extraneous requirements stated by any customer.

[]Are contract reviews including comments of involved organizational units documented[/]

Where contract reviews are determined to be required, they are documented on the Contract Review Form which is then appropriately filed. Meetings are generally individual interfaces as appropriate to this size of a company.

4.3.3 Amendment to a contract

[]Are procedures for amendments to the contract or the order documented[/]

Only contract amendments where a product change or other SIGNIFICANT change (such as a significant volume increase or decrease) are documented.

[]Are amendments to the contract discussed with the involved organizational units[/]

Every 'organizational unit' affected, as determined by the VP of Op, is involved in contract amendments in the same manner as for the original review.

4.3.4 Records

[]Are records of contract reviews being maintained See Quality System Element 4.16 "Control of quality records".[/]

Records are maintained as detailed in the systems manual and the Controlled Document Matrix.