[分享] some hints for QMS audit -6[分享]

4.6 Purchasing

　

4.6.1 General

[]Does the quality manual contain regulations for the product purchasing[/]

Yes.

[]Are purchasing processes defined regarding[/]

Evaluation of suppliers ( The supplier is meant to be the supplier, vendor or service provider.)
Evaluation of suppliers is minimal. The products being bought are commercial grade chemicals


Requisition determination
???


Ordering activities
Yes.


Procedures for handling changes?
Yes.


4.6.2 Evaluation of suppliers

[]Are suppliers selected on the basis of defined criteria For example, first samples, inspections of incoming product, quality audit reports, previous deliveries, certified quality system, recommendations. The selection has to depend on the product type.[/]

Yes, however limited due to the nature of the raw materials used in the product.

[]Are procedures and responsibilities defined concerning the selection of suppliers for:[/]

a) Products
Yes

b) Involved production facilities
NA

c) Services?
Yes

[]Does a product/performance related list/data base of qualified suppliers exist[/]

A list exists and is maintained by the VP of Operations.

[]Are procedures and responsibilities established for:[/]

Accepting new suppliers on the list

Establishing and maintaining quality records of acceptable suppliers

Deleting suppliers from the list? (For example, based on the results of the ongoing supplier assessment)

4.6.3 Purchasing data

[]Are procedures and responsibilities established for[/]

The definition of requirements

The review/release of purchasing documents for
a) Products to be purchased
b) Production facilities to be involved
c) Services to be provided?

[]Do the purchasing documents contain clear descriptions of[/]

Products

Involved production facilities

Services?
For example, type class, grade, product requirements, quality characteristics, standards, quality evidence, identification/marking, packaging requirements, specifications, drawings process requirements, inspection instructions.

[]Where appropriate, do the purchasing documents contain information about applicable standards[/]

4.6.4 Verification of purchased product

[]Are procedures and responsibilities defined for the supplier's verification of the purchased product at the supplier's premises[/]

[]Are there procedures for developing a contract in case the customer wants to verify the purchased product at the supplier's premises [/]

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4.7 Control of Customer-Supplied Product

　

[]Does the quality manual contain regulations for the responsibilities for[/]

Verification

Storage

Maintenance of customer-supplied product?

In regards to: product acceptance, receiving inspection, marking, handling, storage, servicing, maintenance.

[]Are procedures for control of[/]

Lost

Damaged/unsuitable

Defective products established?

[]Is it defined that any such product which is[/]

Lost

Damaged

Otherwise unsuitable for use is recorded and reported to the customer?


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