The *&^$ Findings
Assurance of Independence of Internal Auditors (8.2.2).
Our Internal Audit is done by a contract employee/supplier. Although three members of the steering committee were trained to audit internal audit, we did not have a training certificate. Oh, but we will. DUFAS.
Job Descriptions did not contain competency on the basis of education. (6.2.1)
That's right. For most jobs, we don't have a Diploma or Degree requirement. We are revising to state "degree, etc. or Determined equivalent". DUFAS.
Internal Audit plan not adequate.(8.2.2.4)
The plan was a list of Elements divided into Quarters. The new plan is a Matrix of Opportunity with Teams on one axis and Elements on the other. The opportunities are marked with an X. The plan replaces the X's with 1, 2, 3 or 4 depending on which quarter it will be audited. Assures coverage of all elements and all teams. DUFAS.
Sequence and Interactions (4.1a/b)
You ABSOLUTELY will NOT get by this without a flow chart. The auditor did not understand our version. SO, our Team Organization circle has been overlaid with a flow chart for the auditor's benefit. DUFAS
Metrics/Measurables (5.1.1)
Despite all our work we had a couple of teams that still did not have updated metrics on their scoreboards. OUCH! Oh, but they will
Specifically, Design & Development, Customer Related Processes, Control of Measuring and Monitoring Devices, and Preventive and Predictive Maintenance. The first two are teams just not keeping up their metrics. The last two have me stumped. How do you have performance metrics for calibration?
Inadequate documentation of Manufacturing Feasibility (7.2.2.2)
At least it is not on the Team Feasibility Committment Form from the
APQP book. You can do this all you want but you gotta fill out the form. I just love paperwork done only for Auditors! (Done Up For Auditor's Sake=DUFAS)
Inadequate system for the control and review of Engineering Specifications. (4.2.3.1)
Very tough for us since our TS customer doesn't give us a specific list. We'll make our own.
Lack of Training on
FMEA, APQP, PPAP (6.2.2.2)
If you just read the book and execute flawlessly (no findings on any of these processes by customer or registrar), it is not enough. You must pay AIAG for some training materials and then generate paperwork showing that someone used them. (DUFAS).
No evidence of prototype, prelaunch or production Control Plan (7.3.6.2 & 7.5.1.1)
Yeah, right. Try to manufacture electronics without one. We cover all the bases listed in Annex A, but the auditor could not be bothered. Gin up a "Control Plan" summary on the form in the APQP book and he'll be happy. DUFAS.
Unfamiliarity with Procedures and Work Instructions (4.2.3c and 7.5.1.2)
Remember the training recommendations from Management Review? Here they are!
Obsolete/Uncontrolled Documents (4.2.3)
See previous finding. Auditor would like to see PROCEDURES MANUAL! Please do not pull out keypunch work instructions! Look at your Turtle! It's right there! Training, training, training.
Supplier Monitoring Data (7.4.3.2)
I told you that in Management Review. We're working on it!
Training Records (6.2.2.3)
Doggone Sales Team. Never produced a training matrix. Everyone else did! No you.
No evidence of Predictive Maintenance (7.5.1.4)
Well, I don't have a pump farm or fan house. No constantly lubricated product. How shall I do vibration or oil analysis. No unscheduled downtime on Key Equipment in the past 24 months. How do you predict downtime without downtime. I generate a white paper on subject and say we'll do it when it becomes necessary but you just can't improve on perfection!
No examples of process audits (8.2.2.2)
At least not in auditor friendly format. Our incoming, production and shipping teams are all producing and reporting weekly metrics for on time delivery, first pass yield, scrap, rework and warranty return. These are formally reviewed and approved every quarter. Not good enough. Produce one page audit plan and execute. (Product audit with review of team metrics, auditor OK with product audit records). DUFAS.
OFIs
Interpretation arguement over 7.4.1
"Criteria for selection, evaluation and re-evaluation shall be established." I have estabished critera for re-evaluation: if supplier X does not do Y like I asked, then I re-evaluate them. Auditor says criteria means how often will you re-evaluate supplier. Which is it? I have criteria for new suppliers that says they must be XYZ or they cannot be new suppliers, and criteria for evaluating them to see if they are XYZ. Isn't re-evaluation the same?
No big Controlled Documents stamps all over everything (4.2.3)
My master documents are not stamped "Master Documents". They are in binders that say "Production Manual". Go figure.
You have 21 Continual Improvements, 31 Corrective Actions but only 4 Preventive Actions in your Improvement Database. Go get some more Preventive Actions. (8.5.3)
I thought this was about processes, metrics and improvement. I appears to be about elements, checklists and numbers. DUFAS. Brainstorming to pad the PA list to follow.
Had the audacity to list "lack of proper training" as a root cause on a corrective action". (8.5.2)
Only one. And it was. Oh well.
Management Review Action Items not clearly identified as Improvement of Effectiveness of the QMS, Improvement of Products/Services, or Resources Needs (5.6.3)
So I'll add a column to the Log. DUFAS.
