Feedback on Document Control Procedure

J

JuhoS

#1
Dear all,
I've been lurking in the corners of Cove for the past month or so, and have found this forum extremely useful. In fact, I would be completely lost without it.


Now that I have started drafting ISO9001 quality manual and the accompanying procedures, I would really appreciate feedback on the first drafts on the procedures.


To give a brief background. We are a non-profit based in New-Delhi, India, with a staff of approximately 50 people, working on a community based model of financial inclusion across South Asia. We are looking at getting our implementation process certified. The process consists of an extensive baseline study and a dozen or so different trainings and workshops and lasts approximately one year. We implement through a local partner who is our contact with the communities (customers) we work with.


I have been given fairly strict deadline from the management (end of the year) to implement ISO9001:2008 compatible QMS. Unfortunately the interest is strictly to get the certificate, not necessary to look at the ways in which the QMS will benefit the organization in the long run. I am obviously aware that the approach is completely skewed but for various reasons this is the situation and there is very little I can do to change that. This means that we want to have the bare minimum of documentation in order to have less chances for nonconforming.


Taking this into consideration, I would really appreciate any feedback on first of the procedures: Control of documents (please find attached).


I am having some issues with the control of external documents. Now, this probably sounds stupid but why do I need to specifically control any external documents if I have made it clear that they are not part of the organizations QMS? E.g. if the document is not written in our letterhead, then every employee will identify it as not belonging to our QMS. I am probably missing something crucial here...


Apologies for the lengthy post and thanks in advance!


Juho
 

Attachments

Elsmar Forum Sponsor

Wes Bucey

Quite Involved in Discussions
#2
I'm in a rush and don't have time to look through your attachment, but the text of your post indicates you are on the right track.

External documents MUST be included in your Document Control System ONLY if they impact your operation.

Thus, a purchase order for a product or service your organization supplies (a request for aid?) MUST be included.

Similarly, some other organizations you look to for donations or assistance may have "guidelines" on what data needs to accompany your request - those are also external documents you must control since they have deadlines, data lists, etc. which must be met or the request is delayed until they are provided.

Not EVERY external document needs to be in your system, but certainly SOME might.
 

SteelMaiden

Super Moderator
Super Moderator
#3
I started reading, the first thing I saw was that only electronic documents are controlled. This might well be, but i'd suggest you take another look. You do need to control (as Wes said) external documents that specify requirements, such as customer owned documents. Make absolutely sure that you are not going to have any hard copies that you will need to control. If not, more power to you. I will try to visit your document later on, right now I have a meeting.
 
G

Geoff Withnell

#4
Juho,
Since you have chosen to exclude paper documents from your control system, this means that if someone prints out a copy of a document, and uses it for their work, they are using an uncontrolled document and are not in compliance with ISO. This is fine, if using electronic documents works. But it usually doesn't, people like paper docs. Are you really prepared to forbid their use?

Geoff Withnell
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#5
Juho,
Since you have chosen to exclude paper documents from your control system, this means that if someone prints out a copy of a document, and uses it for their work, they are using an uncontrolled document and are not in compliance with ISO. This is fine, if using electronic documents works. But it usually doesn't, people like paper docs. Are you really prepared to forbid their use?

Geoff Withnell
I've passed many audits with an electronic system that made provisions for paper documents to be printed as needed and discarded after use.
The rule says documents must be controlled... it doesn't say you can't use an uncontrolled copy of a controlled document to do a task.
But make darn sure that uncontrolled copy is current.
 
G

Geoff Withnell

#6
I've passed many audits with an electronic system that made provisions for paper documents to be printed as needed and discarded after use.
The rule says documents must be controlled... it doesn't say you can't use an uncontrolled copy of a controlled document to do a task.
But make darn sure that uncontrolled copy is current.
A semantic question? If the system makes provision for use of paper documents, (controls their use), in what way are they "uncontrolled"? A controlled document is one that we know, because it is being used within the system set up for this purpose, is correct. The paper documents you speak of are in fact controlled documents. I assume you have audit controls or some other mechanism in place to assure that paper docs are not printed, and then just used indefinately? The document control system exists, not to pass an assessment, but to make sure the docs in use are the correct, up to date info. It doesn't matter if you call them "uncontrolled" or "controlled". If your system has made sure they are correct, then they are in reality "controlled documents". If someone is using the wrong doc, it doesn't matter if it is stamped "For Reference Only" or "Uncontrolled". The chance for error still exists. And this is far more important than the chance for an assessment finding.

Geoff Withnell
 
B

Brunetta

#7
I took a moment to briefly look at the attachment and have some questions. I am short on time here though so I am including the first one to get you started. If I have more time later I will post some more, but I see similar possible redundancies/non-value added internal requirements throughout the document. Also, I would caution you to not discount the fact that you may need to keep an obsolete document at somepoint.

Reference Section 1.2.4:
"All controlled documents are reviewed yearly...prior to management review meeting..."
Question:
Are you introducing an additional internal requirement to review documents here? If you are, and from the management position that you have described, then make darn sure any additional requirements above and beyond what ISO 9001 requires is of added value to your organization.
Thoughts behind the question from my experiences:
What is the purpose of a document review...to ensure the documents are adequate in translating high level generic policies (ISO 9001) to real/your world specifics. This implies more than just a cursory read through and someone saying yup they are still good. In our QMS system, document review for adequacy is a necessary part of an internal audit process...during a desk audit. Perhaps you can reduce a redundancy in your system by thinking about how a natural progression of one process can suffice to cover a requirement. I cannot advise you for sure because I am only looking at one facet of your system and not the system as a whole.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#8
A semantic question? If the system makes provision for use of paper documents, (controls their use), in what way are they "uncontrolled"? A controlled document is one that we know, because it is being used within the system set up for this purpose, is correct. The paper documents you speak of are in fact controlled documents. I assume you have audit controls or some other mechanism in place to assure that paper docs are not printed, and then just used indefinately? The document control system exists, not to pass an assessment, but to make sure the docs in use are the correct, up to date info. It doesn't matter if you call them "uncontrolled" or "controlled". If your system has made sure they are correct, then they are in reality "controlled documents". If someone is using the wrong doc, it doesn't matter if it is stamped "For Reference Only" or "Uncontrolled". The chance for error still exists. And this is far more important than the chance for an assessment finding.

Geoff Withnell
Well, Geoff - the way you phrased your first response there led me to believe that you felt that a paper copy in an electronic sysytem is, by nature, uncontrolled.
Yes - we control the copy by putting the rules in place in the procedure and then it becomes controlled....thought there are some auditors who would see it otherwise so the phrasing of the procedure has to be clear.
 
G

Geoff Withnell

#9
No, I guess it was my misunderstanding of the OP, it seemed as if he was forbiding paper use in any manner in his system. I have never seen this work.

Geoff Withnell
 
J

JuhoS

#10
Thank you all for the valuable comments.

I will work on the control of external documents procedure and re-evaluate the lack of control of printed documents. Although, due to the company culture the staff is actually more comfortable in working with electronic copies than hard copies, so I honestly believe that this would not create a problem.

Reference Section 1.2.4:[/I said:
"All controlled documents are reviewed yearly...prior to management review meeting..."
Question:
Are you introducing an additional internal requirement to review documents here? If you are, and from the management position that you have described, then make darn sure any additional requirements above and beyond what ISO 9001 requires is of added value to your organization.
Thoughts behind the question from my experiences:
What is the purpose of a document review...to ensure the documents are adequate in translating high level generic policies (ISO 9001) to real/your world specifics. This implies more than just a cursory read through and someone saying yup they are still good. In our QMS system, document review for adequacy is a necessary part of an internal audit process...during a desk audit. Perhaps you can reduce a redundancy in your system by thinking about how a natural progression of one process can suffice to cover a requirement. I cannot advise you for sure because I am only looking at one facet of your system and not the system as a whole.
Brunetta, thanks for the comment regarding the review of the documents. The reason for this requirement is exactly what you pointed out, i.e. that the review needs to be more than cursory read through.

I can see that the process of Management Review will be a very tough one to physically pull together due to the nature of our work, with the Top Management out of the office most of the time. If the review of the documents can be conducted prior to the actual Management Review this would make it more likely that the Top Management would have time to properly look and evaluate the documents. Re-approval of the documents would be done at the actual Review Meeting.

I'll rephrase the para to make this more clear -- and please do provide more comments.

Thanks!
 
Thread starter Similar threads Forum Replies Date
J Document Control Procedure - Review and Feedback Needed Document Control Systems, Procedures, Forms and Templates 9
P Feedback on Document Control procedure please ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
C Production and Post Production feedback - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
BeaBea ISO 9001 Customer Feedback Methods - What has worked for your company? Service Industry Specific Topics 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
D Social Media Feedback process for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 6
I ISO 9001:2015 Section 9.3.2 C1 "customer satisfaction and feedback from relevant interested parties" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Feedback of typical maintenance problems with LMI digital probes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
F ISO 17025 8.6.2 Customer Feedback Analysis ISO 17025 related Discussions 5
M Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Medical Device and FDA Regulations and Standards News 0
Ed Panek User Feedback both negative and positive and acting upon those metrics 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Informational USFDA draft guidance – Nonbinding Feedback After Certain FDA Inspections of Device Establishments Medical Device and FDA Regulations and Standards News 0
A Have sites like Ebay and Amazon killed customer satisfaction/feedback? Customer Complaints 7
I ISO9001:2015 9.1.2 - Customer Satisfaction Feedback ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Ed Panek Requirement to track and trend positive feedback from customers ISO 13485:2016 - Medical Device Quality Management Systems 12
S GM/VP softgrading internal audit finding - need feedback from an audit guru! General Auditing Discussions 11
K Need feedback: FMEA Web Application FMEA and Control Plans 5
S ISO 13485:2016 ¶ 8.2.1 - How can we obtain feedback for production activities? ISO 13485:2016 - Medical Device Quality Management Systems 5
J AS9100 Rev D Quality Manual Rewritten - Feedback Appreciated Quality Management System (QMS) Manuals 13
L Audit Finding Flowchart for Feedback General Auditing Discussions 6
D Alternatives to Customer Feedback Survey in ISO 9001 Quality Manager and Management Related Issues 4
C 510(k) STED Format - Feedback from users US Food and Drug Administration (FDA) 1
somashekar MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback ISO 13485:2016 - Medical Device Quality Management Systems 35
C PFMEA RPN - Feedback regarding adjusted RPN FMEA and Control Plans 3
S Seeking Feedback on ASQ Guide to Failure Mode and Effect Analysis FMEA and Control Plans 2
J Looking for feedback from current/former Intelex users Quality Assurance and Compliance Software Tools and Solutions 4
S ASQ CSSBB March 1, 2014 Exam Feedback Professional Certifications and Degrees 7
0 Feedback on proposed restructure of Quality Management System (QMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
E Feedback on Negative Experiences with a CB's Service Level Registrars and Notified Bodies 6
E Feedback on the ASQ CSSBB On Oct 5th 2013 Professional Certifications and Degrees 6
smryan Quality Manual - feedback requested ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Customer Survey Assessment Feedback Customer Complaints 11
J Adverse Event Reporting Flowchart (US) - feedback appreciated! Other US Medical Device Regulations 4
J Adverse Event Reporting Flowchart (EU) - feedback appreciated! EU Medical Device Regulations 4
J Flowchart for Canadian Adverse Event Reporting - feedback appreciated! Canada Medical Device Regulations 3
I Feedback on an Environmental Aspects and Impacts Register Miscellaneous Environmental Standards and EMS Related Discussions 5
Crusader Training / Competency Assessment Record for review and feedback Training - Internal, External, Online and Distance Learning 12
T Review of OASIS Feedback - Note on Management Review AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R Customer Feedback - ISO 13485 Section 8.2.1 - Small Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A Feedback on Approach to Flowcharts ISO 9001 Process Maps, Process Mapping and Turtle Diagrams 5
C Customer Feedback, Satisfaction, Complaint Procedure and Measurement Customer Complaints 8
B Online User Feedback Customer Complaints 11
V Can we take a Green Belt project to improve the Internal Customer Feedback Six Sigma 6
R Customer Feedback and ISO 13485 Management Review ISO 13485:2016 - Medical Device Quality Management Systems 2
R Is there an ISO 13485 requirement to solicit Customer Feedback? Customer Complaints 5
V Any experience/feedback on statistical software tools...minitab -design expert -JMP Using Minitab Software 4
S Registrar Ranking - Looking for feedback on SAI Global Registrars and Notified Bodies 8
H Process Audit Checklist Example - Feedback Please Internal Auditing 16

Similar threads

Top Bottom