Audit Findings
OK, everyone, here's the findings:
Section 7.5.2, Validation of processes for production and service provision
ESD worksurface check procedure did not indicate that work should be stopped if surfaces were found out of tolerance. Since the tech did the last test at 5:30p.m. and repairs at 6AM the next day, it could not be proven that work was not taken place due to two different measurement dates.
CA: Update procedure, retest.
Section 8.2.3, Monitoring and measuring of processes
7 different posted instructions that were not controlled. These were all the one page reminder variety.
CA: Sweep for "reminders", create ECO and release under control. Train employees not to create "uncontrolled reminders".
Section 8.2.4, Monitoring and measuring of product
Found 1 test box not signed off out of some 1500 records with dozens of boxes each. Unfortunately, the procedure also did not have the design tolerances listed so 50% of the data did not match the procedure callouts out to 2 decimal places.
CA: Update procedure, train employees on importance of signing off EVERY box.
Section 7.3.6.3, Product Approval Process
MSAs not completed for EVERY instrument used in the measurement of our 1 TS product. Customer had accepted for only Key Control Characteristics but this was documented only by PSW signoff. PPAP had not been extended to all of the 1700 different component suppliers for this product, again, customer accepted but documented only by PSW signoff. Special Characteristics were not identified by a little symbol on
FMEA, control Plan, etc. (the customer had not specified any, we don't consider there to be any, but we take a lot of functional measurements, output voltage, frequency, etc., accepted but not documented, etc.) This is a 2 year old PPAP and the signoff predates our Quality System by 9 months. Unfortunately, we had to use it because otherwise we have not evidence of
APQP/PPAP and get no TS cert.
CA: MSA and supplier PPAP, OUCH. Special characteristics, update FMEA, control plan, test procedures, assembly procedures, adding little squiggly symbol next to appropriate measurements.
Section 7.6, Control of measuring and monitoring devices
Out of 211 pieces in the Calibration pool, found 1 oscilloscope 2 weeks past due for cal and 1 torque wrench that had not been calibrated.
CA: Cal 2 pieces of equipment. Upgrade home built cal database to give past due reports automatically.
Section 7.5.1.1, Control Plan
Control plan did not list Receiving or shipping, only the actual production processes.
CA: Update control plans (2) to add receiving, sub-assembly, and shipping
Section 7.3.3.1, Product design outputs - supplemental
One test had failed a component, design changed, no
DFMEA update. Team Feasibility Commitment not signed by the "Plant Manager" (customer requirement).
CA: Update DFMEA, update Team Feasibility Form.
Except for the MSA and PPAPing an enormous pool of electronic component suppliers, these are all a cakewalk to fix.
Anybody want to tell me how to do an MSA on a torque wrench on an actual nut on an actual product using only the torque wrench and the product? (I'll not buy expensive torque test equipment just so everyone has the same definition of "tight", this is NOT a customer specified measurement).
Anybody want to tell me how to get Avnet or Motorola to send me a PPAP for a .33 cent diode?
ICMT.
