Regular/Annual Document Review in a Company with Thousands of Work Instructions

L

lawsotx

#1
I'm sure this has been asked and info. provided previously in the forums....but I'm unable to locate. Can folks in the forum share how their companies handle their document review....specifically whether they perform an annual review or document a regular timeframe that procedures are required to be looked at to ensure accuracy, etc? During a recent customer audit, the auditor stated that their company performs an "annual" review of all their procedures. She stated we should do the same. (During her audit she did find a procedure that did not reflect what the work area was actually doing.) We are a custom manuf. org. of approx. 500 people with many thousands of work procedures. My head almost exploded when my Mgr agreed and decided he wanted to take it a step further and revise each document to reflect that they have been reviewed...even when there are no changes. In a perfect world this may be a good solution, but I manage the Doc Control system and with only one other person assisting me, all I can think about is the amt. of work involved in revising all these procedures in the system...when I have other value added activies I could be spending my time on. Any ideas?
 
Elsmar Forum Sponsor
#2
Re: Regular/annual document review

It is common in many industries to perform some review of documentation on a regularized basis. I believe that ISO/IEC 17025 for labs does, as (I think) ISO 14001. ISO 9001 has no such requirement, although some implementors might think it's value added and put it in their procedures.

Personally, I don't think it is. If the document control provisions are user friendly and people are encouraged to use them, plus, the internal audit program has the internal auditors doing their job to ensure document control is covered during each audit, then a regularized review, is (IMHO) a waste of management's resources.

Of course, if the customer really wants to make a point of it they will, but one is hardly an issue. Can you demonstrate through your internal audits that you find no systemic issues with out of date documents.

P.S. - your customer auditor needs to get a life too - 1 document? What is she thinking? And what a subject to choose to take issue with, hardly something to get excited about is it?:lmao:
 
Last edited:

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
Re: Regular/annual document review

Even though is not a requirement of ISO 9001 for an organization to actively review documents on an annual basis, I know a few organizations that have instituted this requirement to force them to review thousands of pieces of command media every calendar year to:
  • get rid of unnecessary documents
  • ensure currency of existing ones
  • implement identified process improvement opportunities and ensure that they are reflected in the document, as part of their knowledge management process
  • ensure that the processes interfaces are adequately described in the supporting documentation.
Like you said yourself, this requires tremendous amounts of resources and my suggestion to you is to make sure the process owners realize that they will be required to perform the annual reviews of the command media that is part of their processes. Obviously Doc. Control should not be the function reviewing the documents, because you don't have the knowledge if a given process is accurately reflected in the procedure, or not. When people realize that they will now have to perform this review without additional resources, they might pressure your "accommodating manager" to change his/her mind.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Oh my...

If your manager is insisting that all documents should be reviewed for accuracy perhaps you should gently guide him in the direction that only the process owners are really qualified to judge their own documents...
That should spread a lot of the burden.

How large is your company's auditing function? Can it be covered through a series of audits instead of burdening one or two people?

Sound like your manager is reacting... how long has it been since this audit? Can you give him time to reconsider his direction?
 
F

fuzzy

#5
Re: Regular/annual document review

It is common in many industries to perform some review of documentation on a regularized basis. I believe that ISO/IEC 17025 for labs does, as (I think) ISO 14001. ISO 9001 has no such requirement, although some implementors might think it's value added and put it in their procedures.

Personally, I don't think it is. If the document control provisions are user friendly and people are encouraged to use them, plus, the internal audit program has the internal auditors doing their job to ensure document control is covered during each audit, then a regularized review, is (IMHO) a waste of management's resources.

Of course, if the customer really wants to make a point of it they will, but one is hardly an issue. Can you demonstrate through your internal audits that you find no systemic issues with out of date documents.

P.S. - your customer auditor needs to get a life too - 1 document? What is she thinking? And what a subject to choose to take issue with, hardly something to get excited about is it?:lmao:
My own encounter with this "requirement" came from a German pharma customer who stated, I may recall, that there was a three year review cycle, which we must comply with. I politely declined and cited the absence of any such requirement under our ISO 9001 system.:notme:
 

Randy

Super Moderator
#6
What is the value as opposed to the cost of this process?

Is there an expectation of return or is this something that is just going to be done because it "sounds" like a good idea and we'll get a warm fuzzy from it?

If all these docs are controlled electronically there should be some way to track how many times they have been accessed in the last year, check it. Those doc's that haven't been used in at least 6 months or so roundfile because they're probably bull$hit anyway and most likely serve no purpose other than "gee-whiz" and "golly-gosh-darn".

And finally identify the documents that are "owned" by who is requesting all this work and assign the review of them to him.
 
W

Wanderer1234uk

#7
Hang on to your hats. Reviewing a document does not necessarily mean that you have to revise the document. I assume that you have a Master List of your documents and that they are divided in some logical scheme according to Department, Product and so on. Write a procedure for annual review and with all the managers and tell them what an annual review is.... Some good points were already made by Sidney: getting rid of unnecessary documents; ensuring currency.. and so on. I’m sure you can come up with a few more.

Then, make up a lists of documents in tables and have the relevant people that use the documents the most, sign off in one of the columns as a signoff when they review the document. They should indicate whether to change, update or to obsolete a document. Have a final signature box with a Manager’s approval. And then you would have completed the Annual Review. In our company, this processes doesn't take more than a week. We have around 2,500 documents. The people who use the documents should know the most about the usage of the document. As part of this process and our quality culture, people are asked and trained to always look for disconnects in documents at all times and to initiate a Change Control or inform their managers. This process has worked quite well. Also in the Annual Review you can state how often you will review documents, we do it annually but I know of other company that do it every two or three years. We also have set up an online system to make it easy for people to enter potential changes, which are evaluated by our QA department. And QA decide on the potential impact on the system and whether it is necessary to make a change immediately.

Hope this helps.
 

SteelMaiden

Super Moderator
Super Moderator
#8
When we created our database for document control we added a field for last "verification" date (we already used review to denote what employees do when they are notified of new or revised drawings.) We then created a report where you can pull up a list of documents that you are the approver on that have not been verified for continuing suitability for 1, 2, 3 years (or fraction of). The resulting list of documents includes a link to the document as well as the option to submit revisions at that point or OK the document as is. That date is then stored in the verification field, so we not only know that we are continuing to use a document, it is current, but we also can show the auditor who and when.
 

Raffy

Quite Involved in Discussions
#9
In our end what we did, Our document review is part of the document control procedure. First is to identify and determine the need for documentation. Document review are triggered by any of the following: Organizational Structure Changes, Documenting the Corrective and Preventive Action, Internal and External Audit. Document that are 2 year old and above.
Best regards,
Raffy :cool:
 
G

Geoff Withnell

#10
Re: Regular/annual document review

<Snippage>

P.S. - your customer auditor needs to get a life too - 1 document? What is she thinking? And what a subject to choose to take issue with, hardly something to get excited about is it?:lmao:
One procedure not being followed? How many different procedures do you think an auditor has time to review and then verify are being followed in operations? A finding like this is certainly something that needs to be addressed. I don't believe that doing an annual review of documents is the cure, however. I would look to your training on using documents, on what to do if the document is wrong, and btw, why your internal ausit system didn't find the problem.

Geoff Withnell
 
Thread starter Similar threads Forum Replies Date
S Regular updates of clinical evaluation report EU Medical Device Regulations 6
N Regular meetings with Notified Body EU Medical Device Regulations 13
W ERP Audit Trail audit by FDA? Regular audit trail report template? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
optomist1 ASME Y14.5 Irregular vs Regular Features of Size Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
U Whether First Article Inspection Report- FAI is mandatory for regular Human Factors and Ergonomics in Engineering 4
K Mandatory Electrical Safety Tests - Regular Production Line IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
C TS16949: Product Audit vs. "Regular Checks" Internal Auditing 1
S How is the NB ISO 13485 audit for CE Marking different from regular ISO audit ? EU Medical Device Regulations 5
V P2, P3, P4 Necessity in regular VDA 6.3 Process Audits VDA Standards - Germany's Automotive Standards 4
kedarg6500 Should soft annealing of Copper be done using regular air or in an inert atmosphere ? Manufacturing and Related Processes 2
E Missed Regular Forum Visitors and Moderators Coffee Break and Water Cooler Discussions 14
N Which is more appropriate Regular or Short Run control charting? Statistical Analysis Tools, Techniques and SPC 8
V Difference between Regular and Auditor Edition of TS 16949? IATF 16949 - Automotive Quality Systems Standard 2
S Is it mandatory to monitor customer satisfaction for a non-regular product? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
D Regular testing and monitoring of Food Quality in a Restaurant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J What are the differences between a design dossier and a regular technical file? EU Medical Device Regulations 1
V Should We Evaluate Suppliers on a Regular Basis or only when Issues Arises? Supplier Quality Assurance and other Supplier Issues 7
P Are regular reviews and updates of FMEA's Preventive Actions? IATF 16949 - Automotive Quality Systems Standard 4
D MSA - Can Regular Calibration Replace Bias, Linearity and Stability Studies? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
A Regular meetings instead of Management Review Management Review Meetings and related Processes 7
F Time consuming - Implementing ISO9001 and doing my regular job, too! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
I Do I need to sign off my annual audit calendar? Internal Auditing 2
S Annual Inspection Layout - Based on Customer print ? IATF 16949 - Automotive Quality Systems Standard 8
K Updated MSA with the Annual PPAP validations APQP and PPAP 8
T Annual Validation as a detection mode on a PFMEA? FMEA and Control Plans 5
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
E Annual PPAP+ deviation request ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 11
JoCam Increase to bi-annual ISO 13485 audits ISO 13485:2016 - Medical Device Quality Management Systems 2
S Is Annual QMS Training Required? ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M Informational Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2018 to 2019 Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Medical device annual reporting – Sponsor obligations Medical Device and FDA Regulations and Standards News 0
S Is an Annual Layout Inspection the same as an Annual Re-validation? Internal Auditing 1
M Informational FDA Invites You to the 2019 Regulatory Education for Industry (REdI) Annual Conference Medical Device and FDA Regulations and Standards News 0
S Post Market Surveillance and Annual Product Review in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
qualprod Annual SWOT for 4.1? I plan to revise quality objectives and strategic route ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
qualprod ISO planning annual meeting? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
JoshuaFroud CDRH Annual Report - eSubmitter Other US Medical Device Regulations 0
B Does anyone charge for annual layouts? APQP and PPAP 8
V How to Add Annual Revalidation requirements to Control Plan? FMEA and Control Plans 5
K Is an annual "audit schedule" the same thing as an audit scope/ audit plan? Internal Auditing 8
S What questions to ask in annual supplier evaluation? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Annual Layout requirements for PPAP/Control Plan FMEA and Control Plans 6
W "On An Annual Basis" - Definition ISO 13485:2016 - Medical Device Quality Management Systems 12
D FDA Guidance Document for Preparing Annual Product Reviews US Food and Drug Administration (FDA) 2
Q FDA - Annual Report Submission Format and QMS updates Other US Medical Device Regulations 2
R Registrar Annual Management Fee Registrars and Notified Bodies 4
F ISO/TS 16949 internal audit scope and annual plan Internal Auditing 2
B Annual Internal Inspector Certification Training - Internal, External, Online and Distance Learning 4
S Is an Annual Supplier Evaluation an ISO 9001 requirement? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8

Similar threads

Top Bottom