Challenges in document control, revisional control, and change control

E

evaedge

#1
Hello everyone :bigwave:
First of all, so glad that the Elsmar Cove is back! :D
I wonder if anyone can share their experience how BOMs, drawings, manufacturing instructions, and inspection procedures are linked and controlled in their company...?
My company makes active medical devices.
At our company, the BOM dictates what and how to make a device. The BOM itself has A revision, all components listed on it have revision (the revision of the drawing). It also includes the manufacturing instructions, final acceptance procedures, labels, etc. Everything is controlled and has revision. The problem is, every time any of those documents is changed, the BOM revision has to change, and this goes through a ECO review and approval process. Then Finance creates the new BOM and component revisions in our manufacturing control system (MiSys). The Finance and Operation departments have been complaining that it is very time consuming to go through this process, because we go through changes several times a year. If a Work Order is issued in the beginning of month, and then a change goes through, they have to do a deviation because they are not building to the latest BOM anymore - even if the change is just a document change and does not affect the actual component. I hope I'm explaining our challenges clearly... because frankly I'm confused too...:(
Thank you in advance for your help!! :thanx:
 
Elsmar Forum Sponsor

rob73

looking for answers
#2
Sounds like you have a fairly robust system in place. Unfortunately there are no "easy" ways around this, IMHO document and revision control is one of the most difficult aspects of any QMS. If it works (albeit slowly) don't change it.
 

yodon

Staff member
Super Moderator
#3
Certainly agree with Rob. You *want* those controls in place to be sure everyone is on the same page (so to speak).

That said, there may be some opportunities to streamline. Are the changes for like parts (maybe the same part / different vendor)? If so, maybe you can ensure both parts are, truly alike (effectively interchangeable) then list both parts on the BOM as options.

However, if it's truly design changes, I think an introspective look is important to ensure nothing else gets broken.
 

Project Man

Involved In Discussions
#4
We also manufacture medical devices and we chose to omit the rev level when referring to them in the higher level documents (i.e. Doc# 12345 instead of Doc#12345 Rev A). This allowed us to still follow our procedure of "reviewing all related documents" but we didn't actually have to revise the higher level documents for minor changes to lower level documents.
 

BoardGuy

Quite Involved in Discussions
#5
It really sounds like it time to open a preventive action on this process and form a team to review the current method and to define a new method based on process owners input.

Of course you will need to meet the applicable QMS (ISO 9001 or ISO 13485) and/or regulatory body requirements but you definitely should take some action.
 

mihzago

Trusted Information Resource
#6
In one of the companies I worked for, we had two types of changes (actually more, but two relevant to this discussion), namely 'Design', and 'Documentation".
Documentation type was reserved to minor changes to documents that do not affect the component or design. The amount of documentation and approvals required to process such change was much less than a full 'Design' change.

Also, not sure if you system supports it, but rather than referencing document revisions, we would have links to documents/records, and instead of updating each document to change the rev, we would just modify the link.

If you don't have the linking capability, then maybe you could create a table/matrix, which lists each document and version that you could manually update for each change. It's tedious and error prone, but may be better than updating each document just to change the rev.
 
E

evaedge

#7
It really sounds like it time to open a preventive action on this process and form a team to review the current method and to define a new method based on process owners input.

Of course you will need to meet the applicable QMS (ISO 9001 or ISO 13485) and/or regulatory body requirements but you definitely should take some action.
Thank you BoardGuy! That's a great idea to open a Preventive Action to review this process. Our Management Review is coming up next week and this is one of the items that I'd like to include this in the discussion/recommendation.
 
E

evaedge

#8
Sounds like you have a fairly robust system in place. Unfortunately there are no "easy" ways around this, IMHO document and revision control is one of the most difficult aspects of any QMS. If it works (albeit slowly) don't change it.
Hi Rob - I agree with you. Document control and revision control is probably the most difficult part of the QMS. We definitely want to keep it in control but also try to find a way to streamline it like Yodon mentioned - I just don't know how.... so I would like to find out how other companies handle this process and hopefully find a way that suits us. :)
 

pbojsen

Involved In Discussions
#9
Wow! Sounds painful. This is how we've done it at the last few companies I've worked for in medical devices.

1. The Device Master Record is the document that tells you how to make something. It lists manufacturing specs, quality specs, drawings, etc. It is numbered according to the finished goods number, i.e. product 12345 will have DMR-12345. The tricky part is manufacturing personnel having access to these specs on the floor.

2. The BOM is a document and listed in the DMR as a document.

3. For the components, we do not list those specs on the DMR, we say "see BOM" as all of the items on the BOM have a spec. Each spec (includes ALL specifications including electronic "documents" such as the BOM) is controlled separately.

4. We don't reference revs on the DMR (except maybe a drawing rev = design change), only on the specs themselves.

This cuts down on revisions.

Why is Finance doing BOM changes? Your document control people should be inputting this stuff into the ERP system, notifying Finance when ready for financials to be input. BOM change = engineering change.

I've done document control and doc control/change control systems for a number of years, and you need to keep it as simple as possible or you'll be buried in "no value added" work.
 
Last edited:
Thread starter Similar threads Forum Replies Date
D Has anyone had sudden challenges from Korea-MFDS? Other Medical Device Regulations World-Wide 1
M Informational Device Shortages Update – The US FDA Announces Two New Innovation Challenges on Device Sterilization Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Device Shortages Update: Challenges to encourage the development of new approaches to device sterilization Medical Device and FDA Regulations and Standards News 0
jjmusicjr Starting from scratch - a plethora of challenges for a new Lumber Mill Machine Shop Quality Management System (QMS) Manuals 11
I Who has had to move from ISO 9001:2015 to ISO 13485 and what were the challenges? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D AEA (Aerospace Experience Auditor) Challenges - Finding availability of AEA for witness AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Challenges Incorporating Mobile Devices into Medical Devices Other Medical Device Regulations World-Wide 1
P New Challenges - PaulJSmith Update (November 2016) Coffee Break and Water Cooler Discussions 5
Manix Automotive Warranty Process at Tier 1 Level Challenges and Development Considerations Quality Manager and Management Related Issues 2
K What are the challenges of working in UAE as an Auditor ? General Auditing Discussions 2
AnaMariaVR2 FDA Commissioner: Margaret Hamburg challenges drugmakers 2 supercharge Quality US Food and Drug Administration (FDA) 0
AnaMariaVR2 Strategic Priorities: Responding to the Public Health Challenges of the 21st Century US Food and Drug Administration (FDA) 0
Hershal Update from MSC........ ISO/IEC 17025 - Challenges and Solutions ISO 17025 related Discussions 1
N Design validation challenges - Suggestions for an effective validation method Qualification and Validation (including 21 CFR Part 11) 5
GStough Has this happened to you? Internal Auditor challenges Lead Auditor Internal Auditing 17
K Management Buy In - Management has presented some interesting challenges IATF 16949 - Automotive Quality Systems Standard 11
Q Challenges to the Quality Professional in the 21st Century Philosophy, Gurus, Innovation and Evolution 27
Kevin Mader Management Challenges for the 21st Century, P. Drucker Book, Video, Blog and Web Site Reviews and Recommendations 0
B Document Approval Matrix Benchmarking Document Control Systems, Procedures, Forms and Templates 3
J Document Approval Signature Order Document Control Systems, Procedures, Forms and Templates 10
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
M What is the proper way to document measurements Measurement Uncertainty (MU) 1
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Document "Correspondence IATF 16949 vs ISO13485" available? IATF 16949 - Automotive Quality Systems Standard 0
R Document Retention - Discard hard-copies after scanning? ISO 13485:2016 - Medical Device Quality Management Systems 2
P Mylar plot suppliers in accordance with D6-51991 document AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
I Nitpicking on document released dates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Refusal to Document Complaints Customer Complaints 39
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
I Master Document Access - ISO 9001:2015 clause 7.5.3 Document Control Systems, Procedures, Forms and Templates 5
I Can a document (form) approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Advice needed - Environmental MS - unwritten but customer requests policy document ISO 14001:2015 Specific Discussions 5
T Control of downloaded document copies by employees Document Control Systems, Procedures, Forms and Templates 3
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
I Is highlighting on a printed document considered a change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C QMS Document Management Software Recommendations Quality Assurance and Compliance Software Tools and Solutions 14
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
Sidney Vianna Informational New IAQG Document - AS9100 Clarifications of Intent AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S How to determine & document Organizational Knowledge of a company Document Control Systems, Procedures, Forms and Templates 4

Similar threads

Top Bottom