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 to 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.

-- jel@jelincoln.com