Validation Processes of Production & Servicing - API Q1 clause 5.7.1.5

L

lawcch

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#1
#1
hi, all

anyone can share their experience on how to address the requirements specified in API Q1 clause 5.7.1.5 a) to f) page 15.

The requirements specified in Q1 are the exact wordings in ISO 9001 clause 7.5.2 page a) to e)

there are 6 areas of validation processes:

a) required equipment (maybe related to measuring , inspection and testing equipment, or final product)

b) qualification of personnel (via competency test or certification, specialised training, etc.)

c) use of specific methods or any decision trees diagram or questionnaire include operating parameters, define critical control points

d) determine and define your acceptance criteria of a process or work or QA/ QC inspection and test plan

e) requirements for records as specified in relevant standards, legal requirements
f) re-validation processes (via special condition or circumstances)

Some details also highlighted in API 6D page clause 1.4 where there is no specific validation processes specified in a standard, there must be a minimum of the following:
a) NDE records
b) welding
c) Heat treatment of materials for product construction for metallic products
d) external coating, painting or plating which may affect the product performance.

Please share how you address and fulfill those above requirements where applicable to your manufacturing processes.

Thanks
Lawrence
 
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L

lawcch

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#3
#3
hi all

I read somewhere in this forum, other people had cover this topic of validation of processes.
Therefore, i have found some useful hints and tips on how to address those requirements in relevant API Spec. 6A and 6D Monogram.

Law
 
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