5.7.1.5 Validation of Processes for Production and Servicing

[hariprem26]

Hi Members,

I need some clarification on clause 5.7.1.5, specifically regarding the requirement to validate processes. Currently, we have outsourced processes such as heat treatment, coating, and Non-Destructive Examination. My question is whether we need to obtain a Process Validation report from the outsourced process vendor, or if their Certificate of Conformance (COC) is sufficient to be used as the validation of the process?

 

[deepak12]

Dear Hariprem,

As per clause 5.7.1.5- Validation of processes for production and servicing; If process is being outsouced then you need to follow the requirement of 5.6.1.6 which is that company need to ensure that all elements are satisfied.
For example:
Documents you need to prepare in case of special process is being outsourced :
1- Procedure for special process validation, which includes
a. Approval of Methods, processes or procedure
b. Approval of equipments or machinary
c. Approval of Personnel Qualification
d. Identification of acceptance criteria
e. Requirements of records
f. Revalidation
2- Special Process Validation form

Documents which you need to obtain from your supplier-
1- Personnel Qualification
2- Validated Procedure (In case of NDE, Procedure shall be approved by Level-III)
3- Calibration of MMEs
4- Process Validation Report

If you are able to obtained above mentioned documents it will fulfill the requirements of clause 5.7.1.5

I think now you got clarity on the requirement. Further if you have any question, please feel free to ask.