Change History: What Documents Need a History?

G

gheghe

#1
Does all level (all types) of documents should have history of changes as required? and why? and where this should be? in revision history page?
 
Elsmar Forum Sponsor
R

Raptorwild

#2
:) Hello gheghe,

You should have a documented procedure defining the controls needed to ensure that changes to the current revision status of documents is identified.

How you choose to IDENTIFY the changes is up to your company. Such as a Number or Letter, or "Changes to this document are indicated by:_______."

The Quality Management System documentation shall include:
1) Documented Statements of a quality policy and quality objectives.

2) A Quality Manual.

3) Documented Procedures required by the standard.

4) Documents needed by the organization to ensure the effective planning, operation and control of its processes.

5) Records required by the standard.

Yes you can have a revision history page if that works for your company.

Hope that helps!
Paula :bigwave:
 
#3
I have always put a revision history (something as small as Rev Level, ECO #, and date) for Level I (Quality Manual), Level II (Quality Procedures), and Level III (drawings and work instructions). For Level IV (forms, checklists, etc.) just the most current rev and date). We use a revision page on I, II and work instructions because they tend to be multipage, and a rev block on 1 page drawings.
 
E

energy

#4
Sometimes, it proves interesting

I've seen cases where a change was requested and the history showed that the document was already that which was requested. Like, "It was that before and we changed it because.......". Also, the question, "When was that changed?" Without a history, do we run the risk of going round and round? :vfunny:
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#5
energy said:
I've seen cases where a change was requested and the history showed that the document was already that which was requested. Like, "It was that before and we changed it because.......". Also, the question, "When was that changed?" Without a history, do we run the risk of going round and round?
The answer to the question is "yes", IMHO. People come and go, but some documentation is here to stay. And Newbie may think "Heeeey....this document needs to be revised coz I just changed the process and now it needs to reflect what it is I truly do." Without a properly documented history, not only will Newbie never know that Oldie used to do it that way, Newbie will not understand why Oldie modified the process. Maybe the old way was ineffective. Maybe the old way caused massive quality issues. Maybe the old way resulted in requiring too many resources in this day-and-age of lean manufacturing.

In other words, documentation can be an awful lot like the real world. If we fail to learn from history, we will repeat our mistakes.

I take a lot of heat from some departments for making them clearly document their revision changes, but when I explain why they should, the proverbial lightbulb usually brightens up a bit.
 

Wes Bucey

Prophet of Profit
#6
May I suggest that the "history" is important only when related to reference to documents which fully explain the change. Most engineering drawings are only modified [revised] after a process often termed "engineering change order process" in which the person initiating the change spells out the reasons for the change to convince checkers and approvers down the line to accept the change.

Some companies are VERY anal about this and demand explanations of the ramifications of the change (i.e. should old stock be recalled? do we need new production machinery? etc.)

Other companies are very loosey goosey and do not do a good job of documenting a reason for the change.

This loosey goosey attitude is very prevalent when non-engineering documents are changed (report forms, purchase order blanks, etc.), resulting in a vast array of companies which have "history" pages attached to all documents which carry no more information than the number and date of the revision and no reference to the equivalent of an "engineering change order" (ECO) which reflects the reasoning behind the change. The data in the ECO can be very detailed or not, depending on the nature of the change (consider the difference between a change in dimensions versus a correction for typographical errors.)

In my opinion, lackadaisical attention to Document Management and Control can result in some gross inefficiencies in the operation of an organization. I further believe it is important to document the reasons for change with an easy method for retrieval of that reasoning when considering a new change.
 
J

JodiB

#7
Time saver ; User Friendly

History of document change that clearly states the major changes is useful for current users to identify exactly what is different about the new version, without having to nitpick through the document themselves to try to discover the difference.

For instance, in negotiating a contract it simplifies matters to maintain a table of changes for easy reference.

All of our procedures simply list the revision levels, the word "revision" for nature of change, and the date! How useful is that?? :bonk:
 

Wes Bucey

Prophet of Profit
#8
I guess I'm like the guy in the commercial "Inquiring Minds Want to Know!"

How much more simple to add a few words to "Revision" such as "tolerances changed for more efficient manufacture" or "finish change from Cadmium plating to Electroless Nickel plating"?

Frankly the word "Revision" alone as a reason is redundant, you can put the word at the top of a column and just add the number of the revision if all you want to indicate is the fact there is a newer version of the part or document.

If we are in the Quality business, we are supposed to be the "bright lights" NOT blinders.
 
L

Laura M

#9
Re: History of changes

What are some of the ways the changes are identified?

examples: Revision history in an appendix, Bold or italicized text, Asterix next to the modified paragraph....

The only one that works for deleted text is a revision history.

It would seem after years of creating document control systems there is still discrepancies as to whether the actual modified text needs to be identified. The standard would seem to indicate that the changed needs to be noted where it says "to ensure that changes and the current revision status are identified."

So what are ways that the actual changes are identified?

Laura
 
B

Bigfoot

#10
Re: History of changes

Laura M said:
What are some of the ways the changes are identified?

examples: Revision history in an appendix, Bold or italicized text, Asterix next to the modified paragraph....

The only one that works for deleted text is a revision history.

It would seem after years of creating document control systems there is still discrepancies as to whether the actual modified text needs to be identified. The standard would seem to indicate that the changed needs to be noted where it says "to ensure that changes and the current revision status are identified."

So what are ways that the actual changes are identified?

Laura
I have used most of the ones mentioned above. The 2 which have given me the best results in communicating the nature of the change in a document are; use of a revision history in the document itself (like a revision block used to do on a drawing in the pre-cad days :eek: ), and the use of a different color of text for the font in a document or PFD. IMHO this issue is one of the quickest means of checking the pulse of the organizations committment. Those that are committed and interested in maximum return from their QMS will be doing something that ensures the changes in their documentation / instructions are identified in a manner that aids the user in finding it and reviewing the change. :p
 
Thread starter Similar threads Forum Replies Date
R Control of Documents - Change history question - Changes from previous revision OK? Document Control Systems, Procedures, Forms and Templates 11
M Is There a Revision History or Change Log for Canadian Regulations? Canada Medical Device Regulations 3
A Medical Device DHF (Design History File) - One per Design Change? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
K Where to keep Work Instruction Change History Document Control Systems, Procedures, Forms and Templates 4
M Quality Manual Change History - Can I eliminate the revision record from the manual? Quality Management System (QMS) Manuals 33
Crimpshrine13 Bulk Process (Electroplating), Control Plan, and Process Change IATF 16949 - Automotive Quality Systems Standard 0
S Supplier change management Supplier Quality Assurance and other Supplier Issues 3
X IATF 16949 Section 3.2 Change of ownership IATF 16949 - Automotive Quality Systems Standard 0
S Change in material vendor - Medical device ISO 13485:2016 - Medical Device Quality Management Systems 4
JoCam Change of Legal Manufacturer EU Medical Device Regulations 2
Sidney Vianna Informational ISO/TS 10020:2022 Quality management systems — Organizational change management — Processes Other ISO and International Standards and European Regulations 0
0 Complaints time series significant change Customer Complaints 41
N Malaysia Shelf Life Change Other Medical Device Regulations World-Wide 2
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
O Article 120 - significant change interpretation EU Medical Device Regulations 4
V Would the customer drawing change necessitate re-PPAP of the Product? APQP and PPAP 3
S Do we have to create a new PPAP to our customer if our Sub Contractor had to change? APQP and PPAP 10
M PMA submission change Medical Device and FDA Regulations and Standards News 0
U Change to the manufacturing Date for a device in the field US Medical Device Regulations 0
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 20
K Change in address on ERLM US FDA: Implications to import US Medical Device Regulations 0
N Change our Registrar? Pros and Cons ? Registrars and Notified Bodies 8
F Using non-randomized clinical study for change in existing 510(k) device? US Food and Drug Administration (FDA) 1
FuzzyD ISO 13485 change in process ISO 13485:2016 - Medical Device Quality Management Systems 3
R IVD Label Change China Medical Device Regulations 1
Judy Abbott Change of PVC stabilizer Japan Medical Device Regulations 6
R IVD Label Change Requirements Other Medical Device Regulations World-Wide 0
M EE's - Laptops/Printer Change and Emissions Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
D Document Change Approval ISO 13485:2016 - Medical Device Quality Management Systems 6
mtmt70a Change\ my MTBF Prediction SW Tool from the RELEX tool with yearly Lic. access Telecordia database to another solution. Recommendations? Reliability Analysis - Predictions, Testing and Standards 0
S Can a product option change the product class? CE Marking (Conformité Européene) / CB Scheme 2
M Regulatory Change assessment US Food and Drug Administration (FDA) 3
G Software change management Design and Development of Products and Processes 3
J Changes to OS - Significant change under MDR EU Medical Device Regulations 8
A If document coding is change will there be a revision Document Control Systems, Procedures, Forms and Templates 1
G Change Control for Test Samples Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Z Change color or shape of individual data point in control chart Using Minitab Software 6
J Medical Device Component Change - Testing, Sampling Criteria ISO 14971 - Medical Device Risk Management 3
S When to change the status of a GTIN from "Premarket" to "In Use" ? US Medical Device Regulations 2
Y Is there any EU Significant change guidance issued? EU Medical Device Regulations 5
B How to change hour format to text but not changing the number ? Excel .xls Spreadsheet Templates and Tools 1
N API Q1, Management of Change & Document Change Request Oil and Gas Industry Standards and Regulations 4
adir88 Substantial Change to QMS (Annex IX, Chapter I) EU Medical Device Regulations 0
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
C Change Management Process ISO 14971 - Medical Device Risk Management 8
S ISO13485:2016 7.3.9 design and development change ISO 13485:2016 - Medical Device Quality Management Systems 3
N Change Control for processes & products Manufacturing and Related Processes 7
Quality Specialist Change Control Numbering system Document Control Systems, Procedures, Forms and Templates 7
D Laboratories listed in the Declaration of Conformity change Canada Medical Device Regulations 1
M Change control on Tracking Sheet ISO 13485:2016 - Medical Device Quality Management Systems 11

Similar threads

Top Bottom