Hi Cove :bigwave:

We supply Class 1 Medical Devices, that are Injection Moulded by a sub-contract facility.

These parts have been in existance for over 10 years, long before we or the sub-contractor implemented ISO13485 QMS's.

The established settings for the injection moulding machine do not change (apart from minor adjustments for Melt Flow's and stuff), and have not changed over the years.

We have never received a complaint for an out-of-spec part.

But.......

There is no validation documents for the parts. We do have technical drawings and MDD compliant Technical Files, but no IQ / OQ / PQ as such for the parts. The parts have first off, in-process and final inspections, but are not 100% verified.

Should retrospective validation be conducted, or can I justify satisfactory history of the parts to not warrent validation? Large pharmaceutical companies get very worried when we can't produce validation documents...:o

any responses ?

Retrospective validation(RV) is reviewing your history to justify your NOT conducting the typical IQ,OQ,PQ based on the results.

If you have maintained a history of data from your inspections then you should have no problem establishing a stable process. My only concern would be your statement of adjusting "melt flow's and stuff". I would proceduralize and validate that the minor changes you make do in fact produce the parts to specification and that the individuals responsible for this process are trained to the new procedure and follow it.

Additional information in your RV should include a review of complaints and material NC to show that their is nothing to conclude that you have a problem that needs corrective action. If you do happen to find a problem, use your CAPA system to correct it and document the effectiveness in the RV report.

Establish a protocol upfront on what you intend to do and establish your acceptance criteria. Have all stakeholders sign it and then execute. If you planned well, you should meet your acceptance criteria and conclude a stable process in your report, then again, all stakeholders are to sign to agree with your conclusion.

Good luck!