Audit issues help

T

Timmers

#1
:truce:

I don't know if this is the correct area t post these questions or not, but we recently went through a pre audit and I had some issues that i need help with, and since I did not get to speak to the auditor before he left I could not ask him what some of these actually mean. I am new to all of this so if I sound ignorant or dumb please forgive me.

1. No evidence that our gagetracking software is certified to meet with QS9000 3rd edition. I have called the software vendor and they aren't sure what is needed.

2. No evidence that "Master" blocks (grade 3 ) are adequate to calibrate our measuring equipment. Now, we don't manufacture rockets so we don't have a very tight tolerance on our parts
( most parts we have .030" - .120"). So wouldn't a grade three that is used only for checking and calibrating our equipment be adequate?

3. Calibration procedures do not meet with "international" practices. What are international practices?

4. Develop a "drop off" policy and place visual aids at the working stations. What is a drop off policy?

I hope these questions don't sound silly, but if any one has been through this and knows what I am talking about, I could sure use the help.
 
Elsmar Forum Sponsor
D

D.Scott

#2
Timmers - First and foremost - call the auditor and get his advice on what he found and what he means by the findings.

It looks to me as though there is a lot missing for us to make a definate statement but I will try to venture a guess. My comments are only my opinion and certainly aren't authorative.

1) Not knowing what software you use and what you use it for, I am not sure where he is going - If you only track your gages, I don't know of a requirement for certification. If you are using a gage R&R program in the software, it should follow the MSA guidelines. It was my understanding that commercial software was exempt from this verification but I may not be on the right line of thought here.

2) Your Master Blocks should be traceable to an NIST standard and you should be able to provide calibration certificates for each. The certificate should have all the requirements covered. The Masters should be able to verify accuracy of the calibrated device in increments suitable for your measurement needs. If you stick with 10:1, you should be ok.

3) Not sure here but he could be referring to ISO Guide 17025.

4) This sounds like an "opportunity for improvement" to establish a policy for handling gages on the floor. It sounds like there is currently no organization of gages and they are out on the floor with no control over who has them and maybe no way to verify the current state of calibration. The "drop off area" would serve as a central point for gage control.

These answers are intended to get you going but check with the auditor on these points. It sounds to me like you did pretty well for a pre-audit if those were the only issues. It should be an easy thing to fix and you are on your way.

Good luck - and welcome to the Cove.

Dave
 
#3
Timmers,
You should contact your auditor and review the NCR's. I can provide a "guess" as to what he may be referring to.

"1. No evidence that our gagetracking software is certified to meet with QS9000 3rd edition. I have called the software vendor and they aren't sure what is needed. "
- Products are not certified to QS9000, Companies are. He may be referring to you supplier development process.

"2. No evidence that "Master" blocks (grade 3 ) are adequate to calibrate our measuring equipment. Now, we don't manufacture rockets so we don't have a very tight tolerance on our parts
( most parts we have .030" - .120"). So wouldn't a grade three that is used only for checking and calibrating our equipment be adequate?"
- For QS he may be referring to 4.11.2.a

3. Calibration procedures do not meet with "international" practices. What are international practices?
- For QS he may be referring to 4.11.2.b.1 2nd para.

4. Develop a "drop off" policy and place visual aids at the working stations. What is a drop off policy?
- Never heard of the term.
 
Q

qualitymanager

#5
M Greenway,

Are you referring to the requirement in ISO/IEC 17025:1999 (clause 5.5.7) which says equipment which may have been mishandled (dropping a gauge seems to me mishandling) has to be taken out of service? (I'm no expert on 17025 - I've only done a 2-day overview of the clauses. I don't have any experience with QS-9000).

Arguing the semantics ("drop off policy") I'd interpret what Timmers says as probably meaning a policy on responsibility for custody of items/equipment.

We'll have to wait on the response from the auditor, I guess.


qualitymanager
 
M

M Greenaway

#6
My aplologies.

I was thinking QS9000 when I replied, however probably meant Ford Q1 (I think its in there).
 
R

Randy Stewart

#7
Drop Off

What is a drop off policy?
Our "Drop Off" policy is that dates are posted throughout the shop when gages are due for calibration and the individuals (employee owned gages) who own the due gages drop them off at QA for calibration.
I could be that simple.
I know I don't have all the information from your planning visit so I say this just from the information you provided.
I would question the professionalism of the auditor if s/he left you with these questions after a planning visit. They may not have given you the corrections needed but they sure could have explained themselves better. You can see by the different answers posted here, from people that have been in the trenches for years, and we still don't really know what the auditor was asking for!
If you are responsible for the calibration and the auditor did not go over their findings with you, then IMHO the auditor has not done their job properly. Contact your registrar / account mgr. and get some resolution.
 
M

M Greenaway

#8
Good points Randy.

The audit findings should be specific.

I would be inclined to 'play the game' and close the first finding based on the fact that there is no requirement in QS9000 for calibration management software to be certified to meet with QS9000 third edition.

For the second finding I would ask the auditor to prove they were inadequate.

The third requirement is only a recommendation in QS9000.

And the fourth finding is utter rubbish as there is no requirement for a 'drop off policy' or mandatory visual aids required by QS9000.

Did the auditor have any specific evidence that the system was not working ? Did you hae loads of uncalibrated gauges in use, where calibrated gauges giving erroneous readings, was there an element of gauge management that your computer system could not handle ?
 
T

Timmers

#9
Thanks everyone. You are being very helpful by bringing up all these questions that I never would have thought about. I am having my dept. manager get a hold of the auditor so we can clear up some of these questions.

Thanks again.
 
Thread starter Similar threads Forum Replies Date
K ISO 13485 Audit Finding on Regulatory Issues - Internal Audits ISO 13485:2016 - Medical Device Quality Management Systems 8
H Supplier Audit (Desktop) Issues Supplier Quality Assurance and other Supplier Issues 19
S External Audit Non-Conformance - Control Plan and Inspection Issues IATF 16949 - Automotive Quality Systems Standard 1
A Quality Audit Advice - Past Due Device Calibrations due to Cal Supplier Issues Quality Manager and Management Related Issues 14
MarilynJ6354 Internal Audit Corrective Actions Log issues - ISO 9001 Clause 8.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A ISO 9001 3rd Party Audit Preparation - Open Issues Aspects General Auditing Discussions 81
S Audit finding - "Cost of Poor Quality" reporting - Confidentiality Issues IATF 16949 - Automotive Quality Systems Standard 13
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 6
T COVID, Furlough and ISO9001 Surveillance Audit Coffee Break and Water Cooler Discussions 2
R External Audit and Certificate prorogation due to the pandemic General Auditing Discussions 10
Dean Bell Implementation of Controls as per SOA for Stage 2 Audit IEC 27001 - Information Security Management Systems (ISMS) 0
G Logistic organization and controls - IATF/ISO 9001 audit Nonconformance and Corrective Action 2
Geoff Cotton Performing a Delta Audit General Auditing Discussions 12
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G MSA check list to audit IATF 16949 - Automotive Quality Systems Standard 8
L Open Positions During AS9100 Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L Stage 2 audit - Requirement for 3 months of records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
F Who can sit in/perform an API audit? Oil and Gas Industry Standards and Regulations 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 4
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
Q Internal audit plan template Internal Auditing 5
G Self Assessment Audit from a new potential customer General Auditing Discussions 3
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
M OEM asking for NC report after certification audit. IATF 16949 - Automotive Quality Systems Standard 3
Ooi Yew Jin Customer E audit preparation Quality Manager and Management Related Issues 2
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 4
J Remote Audit Experiences - June 2020 General Auditing Discussions 26
F Product audit sampling plans IATF 16949 - Automotive Quality Systems Standard 3
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
M Supplier Audit Report - Template for second party audit wanted Lean in Manufacturing and Service Industries 1
Stefan Mundt AS9100D Major nonconformity due to recurrence of a NC during a subsequent CB audit. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q ISO 9001:2015 man days for surveillance audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
F ISO 13485 - EU countries that could request another audit ISO 13485:2016 - Medical Device Quality Management Systems 2
H Layered audit updates after COVID-19 shutdowns Process Audits and Layered Process Audits 0
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
Armen Conflict of Interest if I audit the QC department? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
V Generic IATF 16949 Audit Checklist wanted IATF 16949 - Automotive Quality Systems Standard 3
A NB (Notified Body) Audit of Standards ISO 13485:2016 - Medical Device Quality Management Systems 3
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 10
M Any way to execute VDA 6.3 audit remotely? VDA Standards - Germany's Automotive Standards 2
D Audit for ISO and AS 91XX and mitigating exposure to COVID-19 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
D Postpone IATF 16949 audit due to COVID-19 IATF 16949 - Automotive Quality Systems Standard 41
JoCam Certified Body Audit of MDR requirements EU Medical Device Regulations 4
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
Ajit Basrur Track audit findings on Excel tracker Excel .xls Spreadsheet Templates and Tools 9
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16

Similar threads

Top Bottom