Change control on Tracking Sheet

#1
Hello

I would like to get your input/insights into a change control question.

I work for a very small med dev company. I have an excel spreadsheet where I track all my QMS documents (SOPs/WIs/Forms etc). It's a simple spreadsheet that notes the document #, document name, current version, next review date associated 13485 clause and document family (ie Risk Mgt, PMS etc). Instead of having a list of SOPs/WIs in my Quality Manual, I point to this spreadsheet, as our QMS is undergoing rapid evolution. The spreadsheet is a noted QMS document because it is pointed to in Quality Manual.

Although it is updated as needed, it is formally reviewed every 6 months, a record (snapshot) of the spreadsheet is taken and changes since the last review are noted. This record, with its change history, is signed and approved.

Changes to the actual QMS documents are managed via a formal document change control process but this document is more of a tracking document so making changes to it does not have a flow on effect on other parts of the QMS - it is a 'secondary source' so to speak. I looking for feedback on thoughts regarding the need for a formal change control process on this tracking document given that a signed/approved snap shot record (with change history) is taken every 6 months?
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Leader
Admin
#2
I looking for feedback on thoughts regarding the need for a formal change control process on this tracking document given that a signed/approved snap shot record (with change history) is taken every 6 months?
Subject this document to the bureaucracy of a formal change control review seems non-value added to me. This document is like a master index of sub tier documents.
 

Philip B

Quite Involved in Discussions
#3
We denote document changes as 'substantive' or 'administrative'. If substantive, then full change control applies; if administrative, an amendment register is updated with brief details. This case sounds administrative to me.
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#4
it is a 'secondary source'
Good day @MEdgarH ;
Two questions....
1- Why is this "secondary source" needed? (Sounds redundant and like an extra monster to feed).
2- Is it critical to quality (in this case, of the control of documentation) ? In other words, if it is "wrong or gone" can it lead to a nonconformance (of product or process or intended document controls)? If the answer is YES, then I counsel that it be controlled (but I would still challenge yourself/organization as to why it exists).

Hope this helps.
Be well.
 

Tagin

Trusted Information Resource
#5
Changes to the actual QMS documents are managed via a formal document change control process but this document is more of a tracking document so making changes to it does not have a flow on effect on other parts of the QMS - it is a 'secondary source' so to speak.
Is it possible/feasible to make updating this index spreadsheet as the final step of the formal change control process? Otherwise, it is not clear what is supposed to trigger the update of this spreadsheet and keep it in sync with the actual doc changes. This could also help to reduce concern about the 'what-if' of this spreadsheet being out of sync.
 
#6
We denote document changes as 'substantive' or 'administrative'. If substantive, then full change control applies; if administrative, an amendment register is updated with brief details. This case sounds administrative to me.
Thanks for the suggestion. I think this is a good approach.
 
#7
Good day @MEdgarH ;
Two questions....
1- Why is this "secondary source" needed? (Sounds redundant and like an extra monster to feed).
2- Is it critical to quality (in this case, of the control of documentation) ? In other words, if it is "wrong or gone" can it lead to a nonconformance (of product or process or intended document controls)? If the answer is YES, then I counsel that it be controlled (but I would still challenge yourself/organization as to why it exists).

Hope this helps.
Be well.
Thanks it does help :) . In answer to Q1 - This workbook is mainly for convenience and is designed for practical use in a number of scenarios a. to keep track of review dates for periodic QMS doc reviews, b. deciding which QMS docs are in the scope of internal audits (I usu audit by 13485 clauses), c. to assist other teams in the company when they want to know which QMS doc groups are associated with a certain activity, product risk management, PMS, design and development etc. I don't want to turn something that is implemented as a convenience into a millstone!
Q2 - In the main, the only think that would associate it with a non conformance is that if a QMS doc was missing or the 'review' date was incorrect, then I would most likely miss the biennial review date for the QMS document as this will be the only way to really track scheduled 'review' dates across the whole QMS. That would be a non conformance as the QMS documents are reviewed at least every 2 years for currency.
 
#8
Is it possible/feasible to make updating this index spreadsheet as the final step of the formal change control process? Otherwise, it is not clear what is supposed to trigger the update of this spreadsheet and keep it in sync with the actual doc changes. This could also help to reduce concern about the 'what-if' of this spreadsheet being out of sync.
Thank you. This is a good idea. I will do this.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#10
Welcome MEdgarH!

I used to be a Document Control Admin and can appreciate the effort placed in reviews to ensure important documents are current and correct versions are available where and when they are needed.

How you accomplish this is up to you; after all, John C. Abnet correctly stated there is no "shall" for scheduled reviews in 13485.

Nor is there a requirement to keep your list, though it seems like a good tool if it helps keep the accuracy in place.

Overall I want to just encourage you to allow yourself to not over-complicate this. How does your organization handle change? This includes change in design, process and organization. Does the change management mechanism include a step to review documentation and update if needed? That might be enough to keep documents current if people don't skip over that step.
 
Thread starter Similar threads Forum Replies Date
R Software change control process and defect tracking ISO 13485:2016 - Medical Device Quality Management Systems 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
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
H Control of Change i.e. process and WI IATF 16949 - Automotive Quality Systems Standard 9
D Engineering Change order vs. Change Control ISO 13485:2016 - Medical Device Quality Management Systems 3
D GAMP CAT 5 Change Control Qualification and Validation (including 21 CFR Part 11) 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Change Control - Product Name Change and its associated labeling EU Medical Device Regulations 7
U Change Management vs Change Control? Design and Development of Products and Processes 4
R SaMD - Software as a Medical Device - Software change control form ISO 13485:2016 - Medical Device Quality Management Systems 3
Y Informational Change control process - Major vs Minor change - Active class III medical devices ISO 13485:2016 - Medical Device Quality Management Systems 13
T Change control and configuration management - When to create a new model/part number? Other Medical Device and Orthopedic Related Topics 0
JoshuaFroud Change Control - Minimum Requirements and Unhappy Staff ISO 13485:2016 - Medical Device Quality Management Systems 16
N Change Control - Compliance with FDA 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
A Can change control can be closed if the CAPA is still open? Nonconformance and Corrective Action 3
S DHF File Change Control Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Medical Device Website Change Control ISO 13485:2016 - Medical Device Quality Management Systems 3
Y Change Control - General Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Change Control Form vs. Document Change Notification ISO 13485:2016 - Medical Device Quality Management Systems 3
B IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change) IATF 16949 - Automotive Quality Systems Standard 25
R Does anyone have any experience on change control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Challenges in document control, revisional control, and change control Document Control Systems, Procedures, Forms and Templates 8
E Control Plan Contents - Part Number / Latest Change Level FMEA and Control Plans 2
M Document Change Control for a Very Small Business Document Control Systems, Procedures, Forms and Templates 12
S How to connect NCMR, Deviations and Change Control ? Nonconformance and Corrective Action 2
V Can Regulatory Head Initiate/Trigger the Change Control for Quality Procedures US Food and Drug Administration (FDA) 9
T Change Control Requirements when changing Suppliers IATF 16949 - Automotive Quality Systems Standard 4
drgnrider How to control documents that most likely won't change ever ? Document Control Systems, Procedures, Forms and Templates 5
T Paper Quality Manual Change Control Methods Quality Management System (QMS) Manuals 5
A Company Name Change & Control of Documents Document Control Systems, Procedures, Forms and Templates 9
L Use of checksum(s) to control product change(s) Misc. Quality Assurance and Business Systems Related Topics 1
C Change Control Forms Post Software Validation Medical Information Technology, Medical Software and Health Informatics 2
T Searching for books which have content of 7.1.4. Change Control topics Book, Video, Blog and Web Site Reviews and Recommendations 2
C Change Control in a SCRUM World Misc. Quality Assurance and Business Systems Related Topics 3
J Change in our SharePoint Document Control Process - Is this ok? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Is it possible to have a General Change Control SOP and Form? Document Control Systems, Procedures, Forms and Templates 6
H Blood Banking (CFR 21 PART 606) Change Control Requirements US Food and Drug Administration (FDA) 8
K Change Control for Software System that Controls Aspects of GMP Quality Assurance and Compliance Software Tools and Solutions 5
E Help with ECR/DCR Document Change Control Software Validation Qualification and Validation (including 21 CFR Part 11) 6
J ECO (Engineering Change Order) Control for Unreleased Products Document Control Systems, Procedures, Forms and Templates 3
A Change Ratio [Guideline in Control Limit Update] Statistical Analysis Tools, Techniques and SPC 3
L Engineering Change Control Software Systems - Recommendations? Document Control Systems, Procedures, Forms and Templates 2
T TS 16949 compliant Change Control Management Process IATF 16949 - Automotive Quality Systems Standard 3
A Document Control Procedure Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Internal Auditing of Area with Active Change Control Internal Auditing 14

Similar threads

Top Bottom