Easy Access of Obsolete Documents - Corrective Action help needed

L

Lorikat

#1
A little advice.

I have issued a corrective action to management regarding the easy access of obsolete documents. Currently, one can click on a document and an old version may pop up that has a marking of "Released, but is in fact, an old version. During an internal audit, this occured 5 times, and during the registrar's audit it occured 3 times. This CAR is now approaching 2 years, and is till unresolved. I have been working with managemnt to try to resolve the issue with the software. It IS fixable, however, management has just made a final decision to NOT correct the problem and to leave the system "As-Is".

How do I cover myself? I know I can document my side of the issue and state that managemtn refuses to comply. But what else do I need to do, as this will surely come up again and again.
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
Re: Corrective Action help needed

A little advice.

I have issued a corrective action to management regarding the easy access of obsolete documents. Currently, one can click on a document and an old version may pop up that has a marking of "Released, but is in fact, an old version. During an internal audit, this occured 5 times, and during the registrar's audit it occured 3 times. This CAR is now approaching 2 years, and is till unresolved. I have been working with managemnt to try to resolve the issue with the software. It IS fixable, however, management has just made a final decision to NOT correct the problem and to leave the system "As-Is".

How do I cover myself? I know I can document my side of the issue and state that managemtn refuses to comply. But what else do I need to do, as this will surely come up again and again.
Welcome to the Cove. :bigwave:

You say that the phenomenon happened three times during a CB audit. What was the result? How long ago? Was it a registration or surveillance audit?
 
L

Lorikat

#3
Re: Corrective Action help needed

During an Internal audit, while interviewing peopple at random, 5 people pulled up obsolete documents that were marked as "Released". There were several old revsions available, all marked as "Released. The same thing happened during a surveillance audit, 3 times.

The lead assessor was understandable confused as to why all revisions of the same document were available and marked as released, when in fact the older versions were superseded by the new release. Even the auditee thought that the revision they pulled up on the system was the current released version, which it wasn't.
 
B

Bogie

#4
Re: Corrective Action help needed

For covering yourself, either get a management representative to send an email stating their position not to correct the issue. Or, have it documented in the meeting minutes for Management Review.

Covering the company is different at my bet is the ISO Auditor will not let it pass for the next audit and would expect to get a Non-Conformance out of it.
 
L

Lorikat

#5
Re: Corrective Action help needed

I AM the ISO internal auditor. There is no point in continually issuing a nonconformance when Top Management has stated that they WILL not fix the problem. The management Rep. agrees with me, however, top management is chosing to not do anything and is ordering that the CAR be closed and not issued again.

So, exactly what is my stand here? I can document what happened, but I only have a verbal to close the CAR. I don't even think Top Management will document their stand.
 

pkost

Trusted Information Resource
#6
Re: Corrective Action help needed

depending on how brave you are:

I'd take the approach that if it isn't documented, it never happened. Keep raising the CAR until you have a written directive from top management to stop.

I'd also make damn sure that they understood the implications of using obsolete documentation, otherwise I wouldn't be doing my job....but then my job description doesn't say "keep management happy" and I'm an obstinate bugger!
 
A

arios

#7
Re: Corrective Action help needed

I believe the decision to leave the system "As is" is not appropriate. It could have an impact in your product if decisions are made based on obsolete procedures.

If there is no really an option, then consider using hard copies like in the old days, or at least a copy of a master list published and posted where the documents are sued so there is a clearer way to determine if you are consulting the latest version.
 

SteelMaiden

Super Moderator
Super Moderator
#8
Re: Corrective Action help needed

Who is the owner of the document control system? Was issuing a CAR to management the proper assignment? If that nonconformance came up here the assignment would have gone to the head of the quality dept. (me)/management rep (me) because I am the process owner of the document control system.
 
S

Sturmkind

#9
Re: Corrective Action help needed

Lorikat;

My organization addressed the issue pretty simply several years ago by inclusion of the release date and revision number as part of the filename and archiving previous electronic copies into an 'Obsolete' folder on the corporate server. Voila! Problem disappears.

I am startled that in this century there would be management resistance to an effort that would cost little, resolve the opportunity for error, and move toward a site's quality excellence. It may be that your competition has no such qualms about change......

Best of luck!
 

somashekar

Staff member
Super Moderator
#10
Re: Corrective Action help needed

I AM the ISO internal auditor. There is no point in continually issuing a nonconformance when Top Management has stated that they WILL not fix the problem. The management Rep. agrees with me, however, top management is chosing to not do anything and is ordering that the CAR be closed and not issued again.

So, exactly what is my stand here? I can document what happened, but I only have a verbal to close the CAR. I don't even think Top Management will document their stand.
Hi Lorikat.
I guess you are talking about print copy document control and lapse thereoff of the retrieval system when next versions were issued, making any and all documents floating everywhere.
Stop looking at the management for this mess up.
ACTION:
You and your MR (if different from you) take up a clearing drive and flush out all documents old, new, photocopies, from all areas, corners and desk drawers. Nobody will have any such document and they will commit that their area is cleaned up. Distroy all of them physically
Get a person to be responsible for document control and issue control (may be the MR or anyone who operates under the MR) and issue the current document (may be with a color stamp on the reverse) to all users with a signoff from them having number of copies issued. Ban any photocoping or other forms of duplication of these documents.
Any change done, go back to the signoff sheet, get back all the old issued documents first and distroy, issue fresh copies likewise.
It is simple, Is this possible ?
 
Thread starter Similar threads Forum Replies Date
A EASA Easy Access Rules for Continuing Airworthiness - June 2017 EASA and JAA Aviation Standards and Requirements 0
B Complaint Records - Accessing records on Easy Track Software Records and Data - Quality, Legal and Other Evidence 3
W Does anyone have any experience with the Easy Metric System? General Measurement Device and Calibration Topics 2
B Easy Software Needed for Recording Mainly Attribute Data Quality Assurance and Compliance Software Tools and Solutions 2
Q How to provide evidence of Strategic Direction (Easy) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Easy Way of "Implementing" Risk in ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T Metrics and Statistics for Improvement - Easy to implement Statistical Analysis Tools, Techniques and SPC 4
Marc How to Live Easy in China on $475 a Month and still be able to Save Money Immigration and Expatriate Topics 2
N Moisture Analyzer Out of Calibration - Easy Way to Confirm Everything Ok? General Measurement Device and Calibration Topics 3
N Tracking Shelf-Life of Materials - Is there an easy way? ISO 13485:2016 - Medical Device Quality Management Systems 2
K An easy way to distinguish Tooling vs. Equipment Design and Development of Products and Processes 7
G All FDA Regulations in a New Easy Download Format US Food and Drug Administration (FDA) 1
G VERY easy savory baked Thanks Giving party treat Coffee Break and Water Cooler Discussions 0
M How to Implement the QHSE Integrated Management System Easy Steps? Occupational Health & Safety Management Standards 1
smryan EASY Chicken Enchilada dish Imported Legacy Blogs 4
U Easy-Difficult Coffee Break and Water Cooler Discussions 0
J Easy Method to Test a Caliper - Good or bad? General Measurement Device and Calibration Topics 10
B Newbie, easy to follow guide for organizing/assembling very first PPAP booklet APQP and PPAP 3
N SPC Light Program - Easy way of Cpk extraction from multiple control charts Statistical Analysis Tools, Techniques and SPC 4
T Very Basic, Easy Document Control Training - Preferably Powerpoint .ppt Document Control Systems, Procedures, Forms and Templates 6
A 510(k) Ownership Change - Is it painful or is it a pretty easy process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
G BillMyParents makes it easy for kids to spend parents' money After Work and Weekend Discussion Topics 5
S Easy way to determine % (concentration) of NaOH in an aqueous solution? Manufacturing and Related Processes 1
P Easy, Albert... Funny Stuff - Jokes and Humour 0
N A Man Leaves Home - Teaser - Easy Brain Teasers and Puzzles 5
R Recommendations for a Low cost and Easy to Implement Quality Management System Quality Manager and Management Related Issues 9
H Is it easy to change to another field as a quality engineer? Career and Occupation Discussions 3
B Any Easy Way to determine Linearity Study Acceptability? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
L Employee Morale Boosters - Low cost, quick, and easy ideas to boost morale Preventive Action and Continuous Improvement 31
A Proper term for 'Easy Identification'? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R What is this formula? Translating Gage R&R result to something easy to grasp Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
Antonio Vieira Learn any language! Text to Speech - It's easy to speak for example Portuguese After Work and Weekend Discussion Topics 3
B Grammar Made Easy In 23 Steps Funny Stuff - Jokes and Humour 2
Marc Are you affected by hurricane Katrina? New Orleans (The Big Easy) due for a bash? Coffee Break and Water Cooler Discussions 64
S Stamping part numbers on components for easy identification without a print change Document Control Systems, Procedures, Forms and Templates 5
S Shiny new CAPA system! - Easy way to close the old one? Nonconformance and Corrective Action 1
Douglas E. Purdy Pondering "Document Control Made Easy" by Craig Cochran Document Control Systems, Procedures, Forms and Templates 3
B The Idea Generator - Quick and Easy Kaizen Book, Video, Blog and Web Site Reviews and Recommendations 1
M MSA - Bias Study - Is there any easy method to follow and apply? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
Howard Atkins TS 16949 Transition - Easy? Changed Auditor Requirements? IATF 16949 - Automotive Quality Systems Standard 25
Marc ISO9001:2000 Interpretations - Year 2000 Change Easy Or Hard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Need Easy Performance Measures QS-9000 - American Automotive Manufacturers Standard 4
Q FMEA and Risk assessment in Microsoft Access FMEA and Control Plans 6
D Economic Operators, EU Market Access EU Medical Device Regulations 2
Richard Regalado Informational ISO makes available relevant BCMS standards free for online access Business Continuity & Resiliency Planning (BCRP) 6
I Master Document Access - ISO 9001:2015 clause 7.5.3 Document Control Systems, Procedures, Forms and Templates 5
F ISO Certified companies - Is there a list of certified companies that I can access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C Security and access in cGMP facilities Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
P Average access height into an industrial machine (average base plate height) Human Factors and Ergonomics in Engineering 2
K EU MDD Class I Device market access / certification after 26th May 2020 EU Medical Device Regulations 9

Similar threads

Top Bottom