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7.5.2 Validation of Processes for Production and Service Provision
Validate any production or service provision processes where:
The resulting output cannot be verified by subsequent monitoring or measurement.
Where process deficiencies become apparent only after the product is in use or the service has been delivered.
Validation must demonstrate the ability of these processes to achieve planned results
Establish controls for these processes, including, as applicable:
a)Criteria for review and approval
b)Approval of equipment and qualification of personnel
c)Use of specified methods and procedures
d)Requirements for records
e)Revalidation
Key Explanation Points and Tips:
ÞValidation is usually required where product cannot be verified without damaging or destroying the product, e.g. some types of welding, heat-treating; electroplating, rust-proofing, etc. In such instances, the quality of these activities may only be discovered after use. This would generally not be acceptable due to safety (e.g. weld) or aesthetic (evidence of rust or dullness of chrome) reasons.
ÞIn the case of a service (such as pizza delivery within 30 minutes of order placement), if the timeliness of delivery is not verifiable, then validation would be required. However, most service-oriented businesses (e.g. delivery; call center) have some form of monitoring during service execution to ensure service quality.
ÞValidation involves conducting capability studies using a combination of resources - technology, equipment; materials; environment; competent personnel; and production and testing methods that consistently result in a quality product or service.
Document the specific procedures; methods; and combination of resources that achieve this capability, and keep records of ongoing studies to show that you are maintaining this capability. Validation may also require customer or regulatory approval of the process.
ÞYou must keep appropriate records of process validation showing both the achievement of planned results as well as the ongoing maintenance of such capability.
ÞIf you change any part of the proven process capability (e.g. materials, equipment or personnel, etc.), you must revalidate (re-prove) the changed process. It is up to each organization to determine what combination of resources and methods will provide the required consistent process capability and quality of product or service. Include as appropriate, these validation controls in your quality plans.
ÞIf the nature of your product or service is such that it does not require validation (e.g. where product can always be verified by subsequent monitoring or measurement prior to delivery), then you must clearly state this exclusion to your QMS scope, in your Quality manual.
ÞPerformance indicators to measure the effectiveness of processes that validate production processes may include reduction in - defect rates, PPM’s (defective parts per million); validation cycle time; revalidations; etc.
