Understanding The ISO/TS 16949:2002 Standard 

7.5.2 Validation of Processes for Production and Service Provision  

Validate any production or service provision processes where: 

Þ            The resulting output cannot be verified by subsequent monitoring or measurement 

Þ            Where process 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 

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  

7.5.2.1 Validation of production processes - Supplemental 

Apply the requirements of 7.5.2 to all processes for production & service provision 

Key Explanation Points and Tips: 

Þ      Validation is usually required where product quality 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.  

Þ      In such cases, 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 approval of the process (See PPAP clause 7.3.6.3). 

Þ      You must keep appropriate records of process validation showing both the achievement of planned results as well as the ongoing maintenance of such capability (see PPAP clause 7.3.6.3). 

Þ      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 quality product or service. Include as appropriate, validation controls in your control plans. You may need to re-PPAP your product and process. 

Þ      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.