Part Validation for Single Lot Run
Ever have the need to validate one lot of parts from a vendor. Here's some ideas, based on a one lot run off a new molding tool by a vendor prior shipping the tool off to the manufacturer to be used in on-going production. One possible approach --
________ Molding Validation Outline
John E. Lincoln
1. 1. Purpose: To provide a short term one-lot validation of the Injection Molding Press, New Tool, and resulting small one-time run of a [part] lot of approx. [quantity] pieces, to be done by a contract molder [name, address]. After this run the tool will be shipped to [destination] for ongoing production. Once the tool is received by [Manufacturer], it will be formally validated in dedicated press(es) for subsequent production runs. The [part] is a low patient / user risk part [supported by ISO 14971:2019 Risk Management File].
2. 2. Name / address / contact of SLC Molder / Vendor;
3. 3. Injection Molding Press: [Description – Manufacturer, Model, S/N, capacity];
4. 4 . Tool / Mold Description / Number, cavities …;
5. 5. [Part Description], P/N, P/N Specification, Lot Number, Quantity [total, fall-off, released];
6. . 6. Press calibration data (on gauges for: Injection Pressure, Time, Tool Temperature …;)
7. 7. Molding Set-up Card true copy;
8. 8. Molding Lot / Batch actual press run data [Injection Pressure, Time, Tool Temperature …] true copy;
9. 9. Part’s 1st Article Test Results true copy;
10. 10. Part’s QC In-process test data (if any) true copy;
11. 11. Part’s QA Finished Part test /release data true copy;
12. 12. Any Deviations, Non-conformances, Change Orders, if any, and how resolved – true copies (see below).
13. 13. [Manufacturer] receiving / IQC test data for this lot.
For these purposes, a true copy can be a xerographic copy, certified on each document as a “true, exact, complete and unaltered” copy, and signed and dated by an authorized representative for the vendor. Either each document so annotated, or a collective single “certificate” listing each of the documents, stating the above, and signed / dated by an authorized representative for the vendor.
Provide above to assist in drafting a “mini-validation” for that lot, based on the above outline, for [the Manufacturer's] files.
14. Results: Once the above data is gathered, compare the set-up data, the run data / parameters, the 1st Article data, the In-process QC and final lot QA test / dimension data, to the part drawings / specifications, add functional test data (including any destructive stress testing), assembly test data, visual inspection data, et al.
15. Conclusion: Evaluate the requirements for the part to the actual results of the parts in the lot run, and write up the conclusions.
Follow up with a formal validation of the tool in it's assigned injection molding press(es) for continued production.