QMS Compliance Department KPIs

T

TacitBlue

Involved In Discussions
Hi There,

What vital few metrics can I use to gauge the effectiveness of my QMS Compliance Department?

Currently, I am tracking the cycle time for our document control process; however, I am stuck and cannot think of anything else that would really be worth tracking...

I really don't want to chase CAPAs because that is a shared responsibility between my department and our other Quality departments.

What can I do? Anyone out there have a vital few KPIs they can recommend?

**productive comments only please**

Thanks
 
Jen Kirley

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Hello TacitBlue,

I have always found it very difficult to assign metrics to QA functions because QA is a support function that largely depends on the inputs of others for successful outcomes.

When identifying metrics, we must be careful to identify targets that process owners can actually control, and place the focus on those whom QA serves. Funboi rightly questions the value of a metric for cycle time in the document control process, unless it is critical for the organization. As a Document Control Admin for an organization in a regulated industry in a previous life, I can certainly appreciate cycle time, but I want to be sure that cycle time metric reflects activities that are solely under the control of the Document Control Admin.

As another example, suppose we decide to identify a target of ___% CAPAs late. Since CAPAs can be late for many reasons beyond the QA process members' control, we might be more accurate to say ____% CAPAs late without (response) as per (Procedure). That is, CAPAs escalated, late notices sent, or other action called out by procedure.

I hope this makes sense.
 
Last edited:
B

Big Jim

Admin
I would think that one of the most universal KPI for QA would be some measure of product quality. It can be shared with production and engineering in many organizations.
 
B

Big Jim

Admin
Funboi said:
What? :popcorn:
Click to expand...

It's sort of in the name. Quality Assurance. How well you are achieving Product Quality would be a reasonable means of seeing how well Quality Assurance is working for you. Or maybe you have another idea about their role.
 
Jim Wynne

Jim Wynne

Leader
Admin
Big Jim said:
It's sort of in the name. Quality Assurance. How well you are achieving Product Quality would be a reasonable means of seeing how well Quality Assurance is working for you. Or maybe you have another idea about their role.
Click to expand...
Let's remember that the OP has yet to tell us what his QMS Compliance Department actually does.
 
Dazzur

Dazzur

Involved In Discussions
Big Jim said:
It's sort of in the name. Quality Assurance. How well you are achieving Product Quality would be a reasonable means of seeing how well Quality Assurance is working for you. Or maybe you have another idea about their role.
Click to expand...

Wouldn't that be a KPI for Manufacturing? I also think finding objectives to monitor via KPIs for the Quality Assurance Department is some what fruitless. Are there any processes that Quality Assurance handles that directly impacts production or customer satisfaction? I think document control is pretty pointless to be blunt.

Edit (This is a genuine question btw)
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D Proof QMS compliance for class I ISO 13485:2016 - Medical Device Quality Management Systems 1
S Saving QMS documents in cloud drive - Compliance with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 3
S QMS to demonstrate Compliance to Canada, Europe and Japan Other Medical Device Regulations World-Wide 7
Marc What QMS and Regulatory Compliance Software are you using? Quality Assurance and Compliance Software Tools and Solutions 7
T Quality Compliance Software to meet ISO 13485 QMS and 21 CFR 820 Requirements Quality Assurance and Compliance Software Tools and Solutions 3
C Shortcomings of Compliance Focus Quality Management System (QMS) Quality Manager and Management Related Issues 3
Q ISO 13485, ISO 9001 QMS and FDA Requirements - Process vs. Compliance Approach? ISO 13485:2016 - Medical Device Quality Management Systems 4
A QMS and Computerized Software Compliance with Standards US Food and Drug Administration (FDA) 6
A Paperless Compliance - Planning to set up an ISO 13485 compliant QMS ISO 13485:2016 - Medical Device Quality Management Systems 11
N Upgrading ISO 13485:2003 QMS to FDA 21 CFR 820 Compliance ISO 13485:2016 - Medical Device Quality Management Systems 1
J INTERNAL COMMUNCATION OF QMS Quality Management System (QMS) Manuals 2
A QMS Roll out with guidance from ISO 9001 Quality Management System (QMS) Manuals 8
E QMS references in Safety Assurance Case? US Food and Drug Administration (FDA) 4
A Matrix to determine what's needed to create a QMS v ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N ERP for ISO 13485 QMS solution, your experience, reviews ? ISO 13485:2016 - Medical Device Quality Management Systems 1
Tagin Incorporating Large Language Model (LLM) AI into a QMS Coffee Break and Water Cooler Discussions 14
Vader22 INTELEX software for their IATF 16949 QMS IATF 16949 - Automotive Quality Systems Standard 0
B QMS language EU Medical Device Regulations 2
Q Where to place our Safety Program in our QMS? Occupational Health & Safety Management Standards 9
rivariva MDSAP audit QMS preparation Other Medical Device Regulations World-Wide 10
B How much staff input into the QMS is expected? Quality Manager and Management Related Issues 6
giavannatabbs ISO 9001:2015 Control of Records - QMS Communications? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B AS9100 Certification Audit Accounting for Additional Customer QMS Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
T Relation between ISMS and QMS for a SaMD Medical Information Technology, Medical Software and Health Informatics 3
T Errors & Omissions in Creating QMS Procedures AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
A E-signatures for QMS? ISO 13485:2016 - Medical Device Quality Management Systems 4
A Document control system for QMS in Google Drive? Document Control Systems, Procedures, Forms and Templates 6
W Looking for IATF 16949 (and ISO 17025) QMS software Suggestions Quality Tools, Improvement and Analysis 8
B Does anyone copyright their internal QMS documents? Document Control Systems, Procedures, Forms and Templates 24
M Possible topic for Master thesis topic - MDR and QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 4
A New to QMS and regulatory... advice on training/certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
Q UK QMS Requirements UK Medical Device Regulations 2
B QMS On-Boarding ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Questions concerning QMS and/or company specific nonconformance Customer Complaints 2
B ISO cl. 5.3 - Ensuring that the integrity of the QMS is maintained ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Scalable QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Using an online software to maintain your QMS Quality Assurance and Compliance Software Tools and Solutions 7
I QMS and ISO 9001 Misc. Quality Assurance and Business Systems Related Topics 11
E Visual Management Boards & QMS ISO 13485:2016 - Medical Device Quality Management Systems 8
S Disparity between Job Descriptions in QMS & Contract ISO 13485:2016 - Medical Device Quality Management Systems 7
qualprod Minimize tomention other positions to ease the QMS management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S QMS certificate and Samlping EU Medical Device Regulations 0
H Mapping QMS+business processes in a medical device with class I and IIa+b Process Maps, Process Mapping and Turtle Diagrams 3
Y Must Initial importers have any QMS? US Food and Drug Administration (FDA) 1
qualprod QMS global effectiveness? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q 13485 QMS turnkey ISO 13485:2016 - Medical Device Quality Management Systems 10
K New to Medical Device QMS and would like advice ISO 13485:2016 - Medical Device Quality Management Systems 20
N QMS standard for a research based Organisation Quality Manager and Management Related Issues 1
Moncia Integrated QMS and audit Other ISO and International Standards and European Regulations 5

Similar threads

Top Bottom