Control of Documents Procedure - Audit Nonconformance

chris_gray1980

Involved In Discussions
#1
Hi All

it has been a very long time since i posted anything here but i have been sneaking around and using the mass of useful information that this forum provides.

I am still a very frustrated QA Manager in the same job as i was when i posted A LOT a few years ago, but i keep plodding on.

I have recently received a Major NCR for all quality system procedures within my company mainly because they are out of date and have never been updated since the business was changed/restructured before my time. I have been trying to get people to update the procedures for quite a few years and well no one cares to be honest even now we have the major NCR no one seems interested.. SO basically its come to a point where our external auditor said enough is enough and raised the Major NCR which i have to admit i totally agree with, the problem is because its a QUALITY system and i am the group QUALITY manager everyone sees it as my problem and job, they have no idea..

Any way the problem

Our system is based on the old BS5750 standard and its kind of just evolved from there the procedures have got bigger and bigger, there are hundreds of them, they are very wordy and pretty useless. I am trying to start a fresh system (I don't have long) while cherry picking the information that i can use from the old procedures, i want people to actually take note of them and USE THEM.

One of the first ones i have started to look at is Control of Documents. I have created a procedure and called it Control of Documents (Quality System) basically how i write, control and issue the QA Manual, Operational Procedures and Standard Forms, that was fine no problem.. now we have a procedure in our system and it was called control of documents, in this procedure it covered QA docs (can remove that now) Design and project, nothing to do with sale/quoting, etc which i found odd but i have noticed that this information is also repeated in a procedure for Design Control, projects, etc not in its entirety but most of it is the same just worded differently with other aspects thrown in..

The Question

Do i need a documented procedure for Control of documents which covers Design, projects etc just referring to documents when there will be a documented procedure for the whole of Design Control, Project Control, Purchasing Control, etc??

Im not sure if that makes sense or not, the system is a nightmare and i really want to simplify it but i cannot see the wood for the trees..

HELP PLEASE :deadhorse:
 
Elsmar Forum Sponsor

qusys

Trusted Information Resource
#2
Hi All

it has been a very long time since i posted anything here but i have been sneaking around and using the mass of useful information that this forum provides.

I am still a very frustrated QA Manager in the same job as i was when i posted A LOT a few years ago, but i keep plodding on.

I have recently received a Major NCR for all quality system procedures within my company mainly because they are out of date and have never been updated since the business was changed/restructured before my time. I have been trying to get people to update the procedures for quite a few years and well no one cares to be honest even now we have the major NCR no one seems interested.. SO basically its come to a point where our external auditor said enough is enough and raised the Major NCR which i have to admit i totally agree with, the problem is because its a QUALITY system and i am the group QUALITY manager everyone sees it as my problem and job, they have no idea..

Any way the problem

Our system is based on the old BS5750 standard and its kind of just evolved from there the procedures have got bigger and bigger, there are hundreds of them, they are very wordy and pretty useless. I am trying to start a fresh system (I don't have long) while cherry picking the information that i can use from the old procedures, i want people to actually take note of them and USE THEM.

One of the first ones i have started to look at is Control of Documents. I have created a procedure and called it Control of Documents (Quality System) basically how i write, control and issue the QA Manual, Operational Procedures and Standard Forms, that was fine no problem.. now we have a procedure in our system and it was called control of documents, in this procedure it covered QA docs (can remove that now) Design and project, nothing to do with sale/quoting, etc which i found odd but i have noticed that this information is also repeated in a procedure for Design Control, projects, etc not in its entirety but most of it is the same just worded differently with other aspects thrown in..

The Question

Do i need a documented procedure for Control of documents which covers Design, projects etc just referring to documents when there will be a documented procedure for the whole of Design Control, Project Control, Purchasing Control, etc??

Im not sure if that makes sense or not, the system is a nightmare and i really want to simplify it but i cannot see the wood for the trees..

HELP PLEASE :deadhorse:
Hi Cris, a question for you: did internal audit activies never raise this issue that the external auditor evaluated as a major?
In my view , hower not knowing the details of your processes and organization, I perceived a problem of organization rather than controlled procedure. My advice is first to responsibility and authorithies for control of document within the whole organization with regard to the documentation that impact your quality system management, involving all the process owners of QMS processes. Always as a sensation, the issue that the auditor raised might also have impact on records control. Control of documents is a cross activity : the organization shall decide what are the rules to control them , enlarging the the scope to all documentation that have effect on QMS not only Quality Manual.
 

chris_gray1980

Involved In Discussions
#3
Hi qusys,

Unfortunately my internal audits picked up on this problem quite a while and it is reported in my management review for i think the last 2 years, i have tried initiating a review before but it gets ignored or pushed to one side (There is a long thread on here some where about the problems i have had with the system / company) basically it is left down to me and its as simple as that, there are no process owners, well there are they will sign the docs when i have created them.

I agree with everything you say above and what should be done but the fact of teh matter im stuck with just me sorting this out and no one else. I do have a Control of Records procedure as well, which includes all records that are produced and kept by each department for how long and if archived how you go about removing them from the archive, these procedures are pages and pages long, i wanted to go to flow charts and make them nice and simple but i was told by the powers that be that would be a bigger job and stick with what we have and amend it. I understand how a proper management system should work and my role as a quality manager but unfortunately i cannot be a proper quality manager because all the responsibility is with me and no one else. I have even informed everyone that if it is not done by April we could loose our certificate but they now that wont happen because i will just do it i have before with ASME it was just left with me to sort out..

Right that sounds like a huge MOAN sorry, and thank you for your help.
 
#4
Chris:

This is a symptom and you may have to go back to basics with your management team. I'd suggest that there are problems that a lack of effective document control is causing and you should use this (operational) background to re-engage with them. Frankly - and somewhat obviously - management don't give two hoots about documents, despite what we think and ISO says.

You have to find something they will see as important, not document control! Go and do some research about what this is causing, in customer problems, rework and so on, and put a pound sign on it!

I'd suggest also, that you get another CB too. Anyone who has allowed this to go on as long as it has is no better than a thief, quite honestly.
 
M

maeshack

#5
I feel your pain. Not sure I can offer any assistance but sometimes it helps to know you're not alone! We currently have close to 2,000 documents that NO ONE reads or cares about much less updates. I raise this point during every single internal audit. There are minor findings during every single external audit.

My first step right now is creating a "documentation 101" if you will, for the process owners. It's a presentation I'm working on to point out the standard's INTENTION and why having pertinent information relevant to our processes is a GOOD THING that we should all embrace.

I'm also trying to think about ways other than written documentation to replace work instructions and have been tossing around the idea of video instruction. Could we possibly record a process, post it on our intranet and use that in place of written documents? Updating it would be a matter of re-recording the process as it's newly done. The only written documents we'd have then are the system level procedures and the quality manual (because I'd love to move away from paper forms too!!!) I don't know if this would work, like I said I'm just tossing ideas around to see how to manage this very cumbersome burden.
 

qusys

Trusted Information Resource
#6
Hi qusys,

Unfortunately my internal audits picked up on this problem quite a while and it is reported in my management review for i think the last 2 years, i have tried initiating a review before but it gets ignored or pushed to one side (There is a long thread on here some where about the problems i have had with the system / company) basically it is left down to me and its as simple as that, there are no process owners, well there are they will sign the docs when i have created them.

I agree with everything you say above and what should be done but the fact of teh matter im stuck with just me sorting this out and no one else. I do have a Control of Records procedure as well, which includes all records that are produced and kept by each department for how long and if archived how you go about removing them from the archive, these procedures are pages and pages long, i wanted to go to flow charts and make them nice and simple but i was told by the powers that be that would be a bigger job and stick with what we have and amend it. I understand how a proper management system should work and my role as a quality manager but unfortunately i cannot be a proper quality manager because all the responsibility is with me and no one else. I have even informed everyone that if it is not done by April we could loose our certificate but they now that wont happen because i will just do it i have before with ASME it was just left with me to sort out..

Right that sounds like a huge MOAN sorry, and thank you for your help.
Chris,
I have caught your point, but it seems to me that mgmt did not understand the criticality of the problem. If you have a major nc , you shall put in place correction and have to communicate a plan for corrective action to CB within a certain time base as per your CB rules. It is usually 3 months . The CB will re-assess on your premises the plan and the status within a certain time and you are in jeopardy for your certification. Did you have other major ncn? My suggestion is to leverage this isssue and act in multidisciplinary approach. Your CB will want the root cause analysis for the issue as well as correction and corrective action plan. You cannot work alone , otherwise noboby will undestand that QMS belong to the organization and not to one man show.
Try to get sponsorship to mgmt and work in teamworkm trying to coordinate and keep the things simple.
 

LUV-d-4UM

Quite Involved in Discussions
#7
Hi All

it has been a very long time since i posted anything here but i have been sneaking around and using the mass of useful information that this forum provides.

I am still a very frustrated QA Manager in the same job as i was when i posted A LOT a few years ago, but i keep plodding on.

I have recently received a Major NCR for all quality system procedures within my company mainly because they are out of date and have never been updated since the business was changed/restructured before my time. I have been trying to get people to update the procedures for quite a few years and well no one cares to be honest even now we have the major NCR no one seems interested.. SO basically its come to a point where our external auditor said enough is enough and raised the Major NCR which i have to admit i totally agree with, the problem is because its a QUALITY system and i am the group QUALITY manager everyone sees it as my problem and job, they have no idea..

Any way the problem

Our system is based on the old BS5750 standard and its kind of just evolved from there the procedures have got bigger and bigger, there are hundreds of them, they are very wordy and pretty useless. I am trying to start a fresh system (I don't have long) while cherry picking the information that i can use from the old procedures, i want people to actually take note of them and USE THEM.

One of the first ones i have started to look at is Control of Documents. I have created a procedure and called it Control of Documents (Quality System) basically how i write, control and issue the QA Manual, Operational Procedures and Standard Forms, that was fine no problem.. now we have a procedure in our system and it was called control of documents, in this procedure it covered QA docs (can remove that now) Design and project, nothing to do with sale/quoting, etc which i found odd but i have noticed that this information is also repeated in a procedure for Design Control, projects, etc not in its entirety but most of it is the same just worded differently with other aspects thrown in..

The Question

Do i need a documented procedure for Control of documents which covers Design, projects etc just referring to documents when there will be a documented procedure for the whole of Design Control, Project Control, Purchasing Control, etc??

Im not sure if that makes sense or not, the system is a nightmare and i really want to simplify it but i cannot see the wood for the trees..

HELP PLEASE :deadhorse:

Dear Chris,

Have you done a Management Review after the External Audit? If so, then it is the responsibility of your Top Management to allocate the resource (perhaps you need a Document Control Coordinator to update the documents that apply to your process) in order to address this Major NC. Then in the long run, tyhe documents need to be maintained. Your Document Control Procedure should include Management of Change.

You DO NOT NEED a seprate document Control procedure for how to control Design Projects, etc... These should all be covered by the Procedure for Document Control- one of the 6 procedures required by the ISO standard.

Once again, the compliance to ISO is the responsibility of Top Management. The section 5, 6 and partly 8 are all Top Management Related. During the Internal Audit, you need to conduct the audit of Top Management OWNS the Quality Management System. You are accountable to ensure it is maintained with ALL the resources allocated for Continuous improvement of your quality system.

Do not be frustrated. Kepp the COVE Community as your sounding board. I have walked your journey. Keep in touch.
 

chris_gray1980

Involved In Discussions
#8
Qusys,

you are absolutely right in every respect, i have tried explaining how important this matter is but they just ignore it, they see it as a QUALITY problem and because i am the QUALITY manager its my problem and will be my fault if anything happens to our certification. There is unfortunately no one who i can ask help of, everyone is busy with project work, etc and in fact i support them because they have to much one (we have resource issues, i did want or CB to raise it but he said there was nothing he could do)

I have until the 10th April, the audit will not be at my site, there is another site in the group who was given a Major NCR so the audit is taking place their but i will have to present the 'New System' documentation during that audit, i have had a 'plan' basically a Procedure index which has been my way forward but he has seen that several times and nothing has moved from them, issued documents to all people involved with specific processes and basically they are too busy to do anything OR they will just say look OK to me, when i know it bloody isnt, we were a HUGE manufacturing company one and now we are not we are all individual managers of a function, no one underneath, we all have duel role, etc etc... i can go on and on but i get fed up of hearing myself its like a broken record and banging my head against a brick wall...

i better crack on with some copying and pasting at least it will look nice even if its a load of RUBBISH... :mad::mad::mad::mad::mad::mad::mad::mad::mad::mad::mad::mad::mad::mad::mad::mad::mad::mad::mad::mad:
 

chris_gray1980

Involved In Discussions
#9
Hi LUV-d-4UM

Thank you for the reply

Unfortunately if I had done a management review it wouldn't be worth the paper it would be written on, all output from me is meaningless, it is there to fulfil a requirement of a standard, that is it, it goes no further than than, i have a management review - I produce a report-have a 10 min chat - I produce minutes that's it done until next year, the outcomes are about the same.. the problem i get is if i say anything i am moaning, if i don't say anything and something goes wrong its MY fault...

i was kind of hoping this thread wouldn't end up like my last one..

Can anyone offer any guidance on a Control of Documents procedure please, we manufacture pressure vessels if that helps?

PS i do love this forum and everyone on it, you guys and gals inspire me and are how i dream of being one day (if i live that long in this job, may go making sandwiches at this rate)

Thanks again
 

LUV-d-4UM

Quite Involved in Discussions
#10
So your Major NC is systemwide- not just your site. There is a breakdown of the Quality system. It is not your problem to solve it. You must assemble the multi-functional team together and conduct a Root Cause Analysis before implementing a Corrective Action based on the Root Cause identified and agreed bupon be Top Management and team. Then you can provide objective evidence that your Corrective Action is effective by making sure that Awareness training and follow-up audit of Document Control is done.
 
Thread starter Similar threads Forum Replies Date
F Nonconforming Product Procedure vs. Control of Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Link between Control of Documents, CPAR & Control of Non-Conforming Product Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T QSP 4.2.3 Control of Documents Procedure - Content and Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
E Control of documents procedure and external documents? Document Control Systems, Procedures, Forms and Templates 4
L Sample of Control of Document Procedure and Control of External Documents Document Control Systems, Procedures, Forms and Templates 2
F Control of Documents - Effects of Changing the Sign-Off Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Clause 4.2.3 Confusion: Documents that predate the doc control procedure. Document Control Systems, Procedures, Forms and Templates 17
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
R Process control documents - Context of API Spec Q1, Clause 5.7.1.3 Other ISO and International Standards and European Regulations 0
qualityegghead ISO13485:2016 4.2.4 Control Of Documents - Lifetime of the Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
C Defining Approvals Required for Design Control Documents ISO 13485:2016 - Medical Device Quality Management Systems 6
N Responding to NADCAP nonconformance - Control of External Documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
B Control of Duplicate Documents - Limited Scope (long) Document Control Systems, Procedures, Forms and Templates 5
P Document Control - Do hard copies of documents need to be signed? Document Control Systems, Procedures, Forms and Templates 3
M Retiring documents in Document Control Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Managing Level 3 Production Documents - Document Control System Help Document Control Systems, Procedures, Forms and Templates 6
M Document Control Management - External documents flowed down from customers Document Control Systems, Procedures, Forms and Templates 2
S AS9100 Control of Documents and SAP Implementation Document Control Systems, Procedures, Forms and Templates 1
M Control of External Documents such as customer manuals AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 28
Gman2 Control of Documents and (FORMS) on a Computer Network ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
T Information Gathering Documents and Document/Record Control Requirements Document Control Systems, Procedures, Forms and Templates 9
T Customer Specific Documents and Records - ISO 9001 Control Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Control of Records - Differences between Controlled Documents and Controlled Records Records and Data - Quality, Legal and Other Evidence 18
drgnrider Control of External Audit Notes and Documents Document Control Systems, Procedures, Forms and Templates 8
drgnrider How to control documents that most likely won't change ever ? Document Control Systems, Procedures, Forms and Templates 5
U Do we have to have foreign legal documents? (ISO13485 4.2.3 document control) ISO 13485:2016 - Medical Device Quality Management Systems 3
A Company Name Change & Control of Documents Document Control Systems, Procedures, Forms and Templates 9
C Document Control - Details to include on Documents Document Control Systems, Procedures, Forms and Templates 2
N Control of Documents Scope - Product Specifications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J ISO/IEC 17025 - Which External Documents require control? ISO 17025 related Discussions 6
S Read Only & Password Protected - Sufficient to Control Documents under 4.2.3? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
W Control of Obsolete Documents Document Control Systems, Procedures, Forms and Templates 21
T Are Control Plans "Summary Documents" not meant to replace Work Instructions? IATF 16949 - Automotive Quality Systems Standard 3
Q Control Of Documents and Forms - Formats and Numbering Document Control Systems, Procedures, Forms and Templates 3
Q Control of Customer Documents (Documents of External Origin) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T Document Control Master List for Obsolete Documents Document Control Systems, Procedures, Forms and Templates 6
K Control of Documents or Control of Records? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
S Referencing other documents in Control Plans Quality Manager and Management Related Issues 5
L How to control some Documents and Records (ECN's and ECR's) Document Control Systems, Procedures, Forms and Templates 1
P Electronic Record Control (Specifically editable records not fixed documents!) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Document Control using Wiki - Cannot Create all Documents as Wiki Pages Document Control Systems, Procedures, Forms and Templates 10
G Document Control-AS9100 - Marking of Documents as Master Copy of Controlled Copy AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B Reusing paper of Obsolete Documents to Control Waste Document Control Systems, Procedures, Forms and Templates 12
S Document Control - Different documents which must be controlled not identified Document Control Systems, Procedures, Forms and Templates 11
R Which documents to control apart from QMS related procedures? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
C Control of Documents - Converted online in SharePoint Document Control Systems, Procedures, Forms and Templates 9
T External Document (Documents of External Origin) Control Template example wanted Document Control Systems, Procedures, Forms and Templates 14
A Designing a Documents Control System from scratch (in a php intranet) Document Control Systems, Procedures, Forms and Templates 5
R Control of Documents - Drawing (soft copy) for further work by other Consultants Document Control Systems, Procedures, Forms and Templates 1

Similar threads

Top Bottom