Change Order necessary to document FMEA Updates?

cubix rube

Involved In Discussions
#1
We've been treating our PFMEA as a "living document", i.e., we update it fairly frequently, with no real documentation or tracking of revision level. In our last audit, it was pointed out that we should update the rev level whenever we make updates. For every other doc in our system, we initiate a Change Order to change a doc revision. If we are going to track each and every update to our PFMEA, do we need to document this with a change order, too? Curious how others handle this. Thanks!
 
Elsmar Forum Sponsor

howste

Thaumaturge
Super Moderator
#2
I don't know what standard you may be certified to, but the change order requirement is most likely from your own organization, not from the standard. I would ask what value you get from doing a change order for an FMEA update. If there is no value, then make sure that your procedures/work instructions allow you to make changes without a change order while still meeting the document control requirements of the standard.
 
Thread starter Similar threads Forum Replies Date
D Engineering Change Order (ECO) metrics to track ISO 13485:2016 - Medical Device Quality Management Systems 6
Icy Mountain Engineering Change Order...Modification Order Document Control Systems, Procedures, Forms and Templates 18
S Engineering change order versus a design change request ISO 13485:2016 - Medical Device Quality Management Systems 1
M ECO (Engineering Change Order) Record Filing Question Records and Data - Quality, Legal and Other Evidence 1
N Change Order Problem - Want to change things "on the fly" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T Need help developing an ECO (Engineering Change order) procedure Document Control Systems, Procedures, Forms and Templates 3
C Documents not controlled by the ECO (Engineering Change Order) process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J ECO (Engineering Change Order) Control for Unreleased Products Document Control Systems, Procedures, Forms and Templates 3
Q How to close the circle QMS and ECO (Engineering Change Order)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Document Control ECO (Engineering Change Order) or QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D ECO (Engineering Change Order) Risk Management Criteria and QA Document Control Systems, Procedures, Forms and Templates 19
M Change Order Process - Stake holders not following through - Suggestions wanted Manufacturing and Related Processes 5
M ECO (Engineering Change Order) Tracking and Status Report Document Control Systems, Procedures, Forms and Templates 1
T ECO (Engineering Change Order) Implementation checklist/work instruction Document Control Systems, Procedures, Forms and Templates 6
V How to measure ECO (Engineering Change Order) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/DCO) Document Control Systems, Procedures, Forms and Templates 30
R ECO (Engineering Change Order) presentation Document Control Systems, Procedures, Forms and Templates 2
R ECO (Engineering Change Order) Question for all experts (fill the blanks) Document Control Systems, Procedures, Forms and Templates 4
K ECO (Engineering Change Order) Revision - Letter change or part number change? Manufacturing and Related Processes 13
M Using M-1 Software for Quality - Manual Engineering Change Order Entry Quality Assurance and Compliance Software Tools and Solutions 1
C Document Change Order - DCO templete which complies with FDA QSR requirements? ISO 13485:2016 - Medical Device Quality Management Systems 0
CarolX Preventive Action (PA) - Employee Suggestion Box, Engineering Change Order? Preventive Action and Continuous Improvement 12
Raffy ECN (Engineering Change Notice) / ECO (Engineering Change Order) System Document Control Systems, Procedures, Forms and Templates 1
Q Change the shape of the raw material FAI AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
P Notified Body Approval of Change EU Medical Device Regulations 2
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4
J FDA notification of address change US Food and Drug Administration (FDA) 2
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
D List A IVD - Change to material supplier EU Medical Device Regulations 3
R Change Management vs Opportunity for Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Is There a Revision History or Change Log for Canadian Regulations? Canada Medical Device Regulations 3
C Brazil - Product Code (and brand) Change Other Medical Device Regulations World-Wide 0
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
R Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
Marc Insects and Climate Change - 2020 World News 0
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q Company Ownership Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Is highlighting on a printed document considered a change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N China - Start manufacturing before change approval? China Medical Device Regulations 1

Similar threads

Top Bottom