Injection Moulding Process (Special Process) Validation



Dear Brothers & Sisters,

Greeting of the Day..

I need your assistance regarding Process Validation - Injection Moulding Process (Special Process - where the resulting output cannot be verified by subsequent monitoring or measurement)

We are the manufacturers of Kitchen Cutlery Items (Spoon, fork, knife, etc.,), Plastic Cups & plates. As per the ISO 9001:2015 - 8.5.1.f (process validation / revalidation) we need to have this practice but it is not our customer or regulatory requirement for us.

1) For our industry, it is required to perform process validation / revalidation?

- If so, 2) My question is how to perform this validation process hence we have already set the parameters (Machine, Process),

I have suggested the following steps, to perform validation:
  • For Maintenance, Ensure the machine parameters that matching with the Machine Supplier requirements (IQ purpose)
  • I suggested my production team to do the following:
(i) Identify the CPP (Critical Process Parameter) & CQA (Critical Quality Attributes) involved in it.​
(ii) Perform Failure Mode Effective Analysis (FMEA - Process & Product) particularly for CPP & CQA.​
(iii) Perform Trial production and record the data ( for OQ purpose)​
(iii) Collect the data for short term study (Sample lot / batches)​
(iv) Perform Initial Capability Study to ensure the Cpk < 1.33 and approve the process​
(v) Collect the data for long term study (Samples from Continuous regular production on a daily basis up to subgroup level) (CPV)​
(vi) Perform Ongoing SPC Study to ensure the Ppk < 1.67 and Validate the process.​
  • Prepare a revalidation criteria to do revalidation when and where required and follow the above activity to revalidate the process.
Can you help me out either I am on the right direction or need improvement on my way?


Quite Involved in Discussions
What about doing some in -process testing destructive testing? Does not seem to be a "special process".


Involved In Discussions
The approach is sound (although you have mixed the signs - Ppk should be > 1,33 :)). Revalidation criterion can be Cpk < 1,67 - if you analyse the data from one year and Cpk is lower, then revalidate. Just remember to document it.
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