7.5 Production and Service Provision
Control of processes
Production and service should be planned and implemented under controlled conditions this means:
product requirements works instructions suitable / maintained equipment monitoring and measuring devices and techniques with suitable training final inspections / checks tests, delivery and other post delivery support / returned goods Validation of processes - what??
Your must validate any processes where what you make cannot be verified. This might be where deficiencies only come to light during the use of the product. Validation should demonstrate these processes are capable of producing the desired results. Where this is the case (and there are very few, most people should exclude this item) you should define:
review and approval of processes suitable resources (people / equipment / environment) methodology (trained people) records to be retained Identification and Traceability
You must be able to trace a product through production to delivery at every relevant stage / process including it's status and any testing it has undergone. Where appropriate this should include record of which measuring equipment tested in case of faults in the equipment discovered after the fact. This may well include the use of product ID, batch numbers or serial numbers to the required level of detail
Customer Property
Your company must exercise care of a customers property (be it drawings, data, personnel, environment (property or IT), intellectual. This includes identifying, verifying, protecting and safeguarding it. Records shall be maintained and the customer reported to if it is lost, damaged, stolen or unsuitable.
Preservation of Product
Your company shall suitable (be sensible) preserve product during processes and delivery including handling, packaging, storage and protection. This will obviously marked vary according to which type of property it is.
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