ISO 9001 Training
Understanding ISO 9001:2008
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ISO 9001 TrainingUnderstanding ISO 9001:2008
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7 Product Realization 7.5 Production and Service Provision 7.5.2 Validation of Processes for Production and Service Provision The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results. The organization shall establish arrangements for these processes including, as applicable: a) defined criteria for review and approval of the processes, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records (see 4.2.4), and e) revalidation. |
ISO 9001 Training - Key Explanation
Points and Tips:
Validation 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 during or after use. This would generally not be acceptable due to safety (e.g. weld) or
aesthetic (evidence of rust or dullness of chrome) reasons.
In
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 and on-time
delivery.
Validation 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 ( e.g. certain types of welding for certain types of products that have a safety
risk).
You must keep appropriate records of
process validation showing both the achievement of planned results as well as the ongoing maintenance of such
capability.
If 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.
If 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.
Performance 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.