Process Validation of inherited tooling by Contract Manufacturer

So, we are a contract Manufacturer, plastic injection molding, who have been running millions of shots for our customer. Now our customer has turned ownership of the tool over to us and I'm at a loss as to how to document Validation. The tooling is very old and has been at our shop for years. If there was an initial validation run, no documentation exists that I'm aware of... So, I'm looking for anyone who has experienced this, and how does one go about documenting Process Validation? Lot inspection / testing has been part of the process for years but, I don't have any hard data to do a statistical analysis... I have number of shots run (in the millions) but don't have any idea of scrap, etc. Sure hope someone has an answer for me... My idea was just a note to file stating that because the tool has been in production for years without any design changes, and the parts all pass inspection, therefore they are in a "validated state". ???

Re: Process Validation of inherited tooling by Contract Mfgr

peter_traina said:

So, we are a contract Manufacturer, plastic injection molding, who have been running millions of shots for our customer. Now our customer has turned ownership of the tool over to us and I'm at a loss as to how to document Validation. The tooling is very old and has been at our shop for years. If there was an initial validation run, no documentation exists that I'm aware of... So, I'm looking for anyone who has experienced this, and how does one go about documenting Process Validation? Lot inspection / testing has been part of the process for years but, I don't have any hard data to do a statistical analysis... I have number of shots run (in the millions) but don't have any idea of scrap, etc. Sure hope someone has an answer for me... My idea was just a note to file stating that because the tool has been in production for years without any design changes, and the parts all pass inspection, therefore they are in a "validated state". ???

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I would not consider the "note to file" but instead consider the "Retrospective Validation" - http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114942.htm

Retrospective process validation may be used, if adequate, for products which may have been on the market without sufficient pre-production process validation. Extensive review of manufacturing and assembly process data, along with product testing, may be used as a type of validation for devices manufactured individually or on a one time basis.

Re: Process Validation of inherited tooling by Contract Mfgr

peter_traina said:

So, we are a contract Manufacturer, plastic injection molding, who have been running millions of shots for our customer. Now our customer has turned ownership of the tool over to us and I'm at a loss as to how to document Validation. The tooling is very old and has been at our shop for years. If there was an initial validation run, no documentation exists that I'm aware of... So, I'm looking for anyone who has experienced this, and how does one go about documenting Process Validation? Lot inspection / testing has been part of the process for years but, I don't have any hard data to do a statistical analysis... I have number of shots run (in the millions) but don't have any idea of scrap, etc. Sure hope someone has an answer for me... My idea was just a note to file stating that because the tool has been in production for years without any design changes, and the parts all pass inspection, therefore they are in a "validated state". ???

Click to expand...

We have been validating legacy molds (running for over 20 years in different countries) and now transfer to our site. This is a different scenario from you , wherein your molds is running on same site but transfer ownership only. I would suggest to start validating using your existing machines , existing processes (parameters).
For Installation Qualification - make sure your machine , auxilliaries are installed and working properly , need documentation for this , a checklist is good enough to cover this , machine and auxiliaries is calibrated with reference to your company calibration procedure and frequency.
For Operational Qualification - dig out your old scientific molding study and test if still applicable to the current state of the mold. If not develop a new scientific molding study with the current state of the mold . From there run the Min and Max parameter and document it.
For PQ run , you can compile the current production data's and document it.

Re: Process Validation of inherited tooling by Contract Mfgr

So, the way I read it, you're basically saying just to run the IOPQ's for the process as it exists today and that this is sufficient...? How do you cover the history?

Re: Process Validation of inherited tooling by Contract Mfgr

peter_traina said:

So, the way I read it, you're basically saying just to run the IOPQ's for the process as it exists today and that this is sufficient...? How do you cover the history?

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That would be the case , and it should be sufficient enough to prove that your process is capable. As for the tooling history , you can add some statement in the validation report highlighting tooling history or process history.