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. My question is how to perform this validation process hence we have already set the parameters (Machine, Process), 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) (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?