SBS - The best value in QMS software

Questionable Audit Finding about Revision Levels of Product Manual CD's

J

Janselm

#1
We recently had our external audit and our auditor came up with a finding that I personally do not believe is a real non-conformance or problem.

Our shipping department keeps CD copies of all documentation (product manuals, spec sheets, etc.) for each product. Each of the documents on the CD has its own revision level. Each CD is named in accordance to their respective product. When shipping goes to package a product, the correct CD is placed in the shipping container. Our documentation department keeps track of what is on the CD's and in the event that one of the documents is revised they personally go to shipping, dispose of the old CD's and give them new ones.

Our auditor claims that this is a non-conformance because the CD's themselves are required to have their own revision level.

Here is the exact finding:

[FONT=&quot]Requirement:[/FONT][FONT=&quot] Section 6.3.2 of Procedure 7 states documents are controlled by a revision number.[/FONT]
[FONT=&quot]Non Conformance: [/FONT][FONT=&quot]Documents used were not controlled as required by the procedure. There was no revision indicator.[/FONT]
[FONT=&quot]Evidence: [/FONT][FONT=&quot]Product manual CD's in shipping.[/FONT]

To me, since the documents on the CD's themselves contain a revision number, the CD itself does not need one. I don't believe there is any need for the CD's to have a revision number since
1: They are not documents so the procedure doesn't really apply
2: The content of the CD's is controlled in a fashion that will prevent obsolete documents to be shipped out with the product.

Any suggestions on what I should do?
 
Elsmar Forum Sponsor
R

Reg Morrison

#2
Re: Bupkis Audit Finding about Revision Levels of Product Manual CD's

Any suggestions on what I should do?
Yes, drop the CD's altogether and let customers know where (online) they should go to download any document they need. IMHO, a much more elegant, cost-effective, modern and environmental-friendly solution.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#3
Re: Bupkis Audit Finding about Revision Levels of Product Manual CD's

Yes, drop the CD's altogether and let customers know where (online) they should go to download any document they need. IMHO, a much more elegant, cost-effective, modern and environmental-friendly solution.
A great long term solution unless your customer base is not fully up on the latest technology like an internet connection.

The OP's issue is that their internal procedures require documents to have a revision number. The auditor interpreted the CD as a document. In reality, the CD is not in and of itself a document. It contains (electronic) documents that do have . The CD is a delivery and storage device and that doesn't require version control per their internal procedures. The gap lies in the interpretation of what the CD is.

The standard of course only requires version control such that outdated versions are not inadvertantly used. The OP can demonstrate that they meet this requirement.

there are a few options here
  • argue with the auditor
  • chagne the internal procedure to better define what a document is (my personal preference)
  • agree with the auditor and put a version number on the CD

yes its a picky finding. It should have been a point of rational discussion. but it wasn't
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Re: Bupkis Audit Finding about Revision Levels of Product Manual CD's

<snip> Our documentation department keeps track of what is on the CD's and in the event that one of the documents is revised they personally go to shipping, dispose of the old CD's and give them new ones. <snip>
I have to agree with the auditor if the CD has manuals and/or other controlled documents on it. How else do you know what revision document(s) are on the CD?

If they personally do this and have records of having done it, you can call the auditor on it. But...

I have gone through that route where I have gotten outdated documents on CDs that didn't have a revision date or other way to tell what was on the CD.

I do agree with Reg - Put them on the internet and put something in or on the box with the URL to the documents. My last 2 computers do not even have CD/DVD drives.

I do understand Bev's comment - That your customer base may not be fully up on the latest technology like an internet connection, but in that case... There's no guarantee they have a CD drive to begin with.

My opinion - Paper or internet URL. CDs and DVDs are dinosaurs. Remember floppy disks? I still have an 8" floppy around here somewhere as a "momento" of the 1980's...
 
Last edited:

normzone

Trusted Information Resource
#5
Re: Bupkis Audit Finding about Revision Levels of Product Manual CD's

Some of our end users (military folks in the field) may not have reliable access to the web. For that reason we periodically choose to maintain both online and CD versions.

" If they personally do this and have records of having done it, you can call the auditor on it. But...

I have gone through that route where I have gotten outdated documents on CDs that didn't have a revision date or other way to tell what was on the CD. "

My experience as well. Doing that purge of obsolete CDs I believe, maintaining records to prove it is unlikely.

Besides, how much burden does it add to put a rev level on the CD ? Assuming, of course, that the artwork for the CD label is already tracked.
 
J

Janselm

#6
Unfortunately, putting it up on the internet is not an option for us. Our management is very "cautious" of who can get our documentation and how they can get it. With only a few real competitors in our business (RF Matrices) they are worried that having our manuals on the internet may expose them to our competitors.

What we ended up doing is giving the CD's rev levels and each one will have a log of exactly what documents and what revision levels of those documents are contained on the CD's. The log rev level and the CD rev level will always match. Our shipping personnel will compare the revision of the CD with the electronic revision of the log each time before shipping to assure they match. We submitted the action plan and our auditor accepted it.

Thanks everyone for your help.
 

normzone

Trusted Information Resource
#7
Good choice. Only today we were discussing a disk we received from a large computer equipment manufacturer that was made up of a random collection of uncontrolled files.
 

dgriffith

Quite Involved in Discussions
#8
Unfortunately, putting it up on the internet is not an option for us. Our management is very "cautious" of who can get our documentation and how they can get it. With only a few real competitors in our business (RF Matrices) they are worried that having our manuals on the internet may expose them to our competitors.
Depending on the size of the company, a firewalled intra-net would work. It's what we use. Then, the official copy is on-line, and anything printed for use becomes uncontrolled--just tell the auditor that the controlled version is located on-line and be able to demonstrate that you can find it.
 
Thread starter Similar threads Forum Replies Date
A Acceptance Criteria - ISO 9001:2008 Clause 8.2.4 - Questionable Audit Finding? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 40
Mikey324 Questionable Audit Findings after Rules 4th Edition Release IATF 16949 - Automotive Quality Systems Standard 4
E CAR (Corrective Action Report) with questionable Root Cause ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
T Questionable President - John Quincy Adams Brain Teasers and Puzzles 18
I ISO 9001: 2008 Implementation - Quality Manual First -> Questionable approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
M IATF - Internal Audit 3 year span Internal Auditing 2
Q Audit report template ISO 9001/14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Supplier audit Medical Device and FDA Regulations and Standards News 2
M Go Live With New ERP System before Recertification Audit General Auditing Discussions 6
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
A Define timeline for Major and Miner Audit finding General Auditing Discussions 4
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 8
B Remote IATF 16949 audit preparation General Auditing Discussions 10
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
I Do I need to sign off my annual audit calendar? Internal Auditing 2
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Nice and simple invitation email to an audit kickoff meeting Internal Auditing 1
M IATF 16949 - Audit of Remote Location/Support Site and IT IATF 16949 - Automotive Quality Systems Standard 4
Q IATF audit - Root Cause Analysis results IATF 16949 - Automotive Quality Systems Standard 5
Q Self-assessment audit information Quality Management System (QMS) Manuals 6
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
xfngrs NIOSH Audit for N95 respirators US Food and Drug Administration (FDA) 1
Sidney Vianna IATF 16949 News Risked Based Audit Day Calculation IATF 16949 - Automotive Quality Systems Standard 2
T AS9100 audit due to facility move AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
B SAP Audit trail Periodic Review EU Medical Device Regulations 1
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
R Gap Audit Aerospsace and Rail QMS Quality Manager and Management Related Issues 0
salaheddine96 Internal audit planning Internal Auditing 2
A MDSAP Audit Questionnaire Medical Device and FDA Regulations and Standards News 7
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
R ISO 17025 vertical audit checklist wanted Document Control Systems, Procedures, Forms and Templates 2
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
S Quality Audit Training Activities Quality Manager and Management Related Issues 2
G IATF Rules for COVID 5th revision - Re-certification audit timing IATF 16949 - Automotive Quality Systems Standard 3
E MDR internal audit Internal Auditing 1
Ed Panek Remote Audit GOTOMEETING thoughts Coffee Break and Water Cooler Discussions 22
B ISO 9001 - "Remote Audit Fee" Registrars and Notified Bodies 13
L IATF external audit virtual (remote) IATF 16949 - Automotive Quality Systems Standard 13
M Audit Criteria Training Materials Internal Auditing 1
K New supplier audit as per V3.1 by French Automotive OEM General Auditing Discussions 2

Similar threads

Top Bottom