SBS - The Best Value in QMS software

Can corrective actions be written by and resolved by the same person?

E

ehoqa

#1
Can a corrective action or preventive action be written by and assigned to the same person? Apologies if this has been a topic. I didn't find any relevant search results.

Here's the scenario: We are a small medical device company with less than 10 people. I am in Quality, and I also do doc control. One of my findings during an internal audit for another process was that the auditee could not locate specific procedures or work instructions. I figured the root cause goes deeper than a training issue because the auditee was aware where documents are but specific documents are difficult to find. It's our ineffective document control structure. The documents are poorly organized-- if I didn't work in doc control, I'd be clueless where specific documents are located as well.

So, I'm starting a corrective action because I found the problem. Who is it assigned to, who resolves it, and who verifies it? Me? Will that look funny?
 
Elsmar Forum Sponsor
R

Reg Morrison

#2
So, I'm starting a corrective action because I found the problem. Who is it assigned to, who resolves it, and who verifies it? Me? Will that look funny?
Don't confuse corrective action request (CAR) with corrective action (CA). You triggered a CAR because you (as an internal auditor) found a significant issue with the (doc control) system. Because you "own" the doc control process (to an extent), you happen to be in the best position to identify the root cause of the problem and how to solve/mitigate the problem.

There is nothing wrong with the same person being in both ends of the process. The only thing I would suggest is that you run your proposed restructuring of the document control system by other folks. Since doc control might affect several processes and functions, you don't want to create a new problem, fixing an old one. It is always a good idea to have a few perspectives on proposed solutions. Sometimes, we are too close to the tree to see the forest.
 

Mark Meer

Trusted Information Resource
#3
Agree with Reg Morrison.

I don't think it'd be strange, especially given that it goes without saying that in small companies everyone is likely to hold multiple/overlapping responsibilities.

Imagine if you were a company of 1. Granted you wouldn't be doing the internal audit, but in terms of issuing a CAR, implementing and followup of actions, it'd be all you!
 

mihzago

Trusted Information Resource
#5
as long as you have an independent person review your plan and implementation, you should be OK.
Also make sure that someone other than you verifies the effectiveness of the CA. Maybe stage an internal "usability" study;
In addition, you may include this CAPA in the audit plan for the next internal audit (again performed by someone other than you).
 

Big Jim

Super Moderator
#6
It may be worth considering this topic on a case to case basis. Most of the time there should be no cause for concern. Some situations may literally scream the need for an independent person to handle it.
 
Thread starter Similar threads Forum Replies Date
D Northern Ireland Field Safety Corrective Actions (FSCA) UK Medical Device Regulations 5
A Corrective Actions and the 5 why's Training - Internal, External, Online and Distance Learning 2
Q Determining Adverse Effects of Corrective/Preventive Actions ISO 13485:2016 - Medical Device Quality Management Systems 2
M Risk and Corrective actions - Currently no FMEA's - Car systems Risk Management Principles and Generic Guidelines 8
qualprod Do we have to document all corrections and corrective actions in ISO 9001 10.2.2 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
G Differences - Nonconformances vs CAPA, Corrections vs Corrective Actions ISO 13485:2016 - Medical Device Quality Management Systems 16
F Vigilance Reporting - Requirements for manufacturer Field Corrective Actions (FCAs) Other Medical Device Regulations World-Wide 5
A Agenda for 8D audit on Supplier's side - Auditing Corrective Actions General Auditing Discussions 5
I Audit Nonconformances - Can reported corrective actions be incomplete? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
E ISO 9001:2105 - Are OFI or Corrective actions required? Preventive Action and Continuous Improvement 55
M Informal Corrective Actions - AS9100DCl. 10.2.1 A-H Nonconformance and Corrective Action 12
O Updating "opportunities" resulting from Corrective Actions Nonconformance and Corrective Action 2
MarilynJ6354 Missing Corrective Actions - Workforce does not trigger corrective action requests General Auditing Discussions 6
Q Timeframe to resolve Corrective Actions (Undue Delay) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G Non Value Added Corrective Actions IATF 16949 - Automotive Quality Systems Standard 15
MarilynJ6354 Internal Audit Corrective Actions Internal Auditing 5
J Where to get meddev FSCA (Field Safety Corrective Actions) trainings EU Medical Device Regulations 7
B Verification of Corrective Actions based on Quantities Nonconformance and Corrective Action 6
M Benchmarking - Timely Closure of Corrective Actions Nonconformance and Corrective Action 3
M Singapore - New Field Safety Corrective Actions (FSCA) Process Other Medical Device Regulations World-Wide 1
W Corrective /Preventative/Rectification actions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
S TS 16949 - 8.5.2.4 - When are Corrective Actions required IATF 16949 - Automotive Quality Systems Standard 5
H Corrective and Preventive Actions Process Examples IATF 16949 - Automotive Quality Systems Standard 2
L An Auditor gave a finding for Ineffective Corrective Actions IATF 16949 - Automotive Quality Systems Standard 13
J How to assign a Leader to respond to Corrective Actions Nonconformance and Corrective Action 7
D Supplier Nonconformance & Corrective Actions Procedures Nonconformance and Corrective Action 1
O Corrective Actions identifed as Preventive Actions Nonconformance and Corrective Action 10
R Tracking Corrective Actions using an Excel sheet Excel .xls Spreadsheet Templates and Tools 7
J Auditing Supplier Corrective Actions Supplier Quality Assurance and other Supplier Issues 3
F Software or form/templates program to track Internal Audits and Corrective Actions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
E Corrective Actions Root Causes from Surveillance Audit Findings Nonconformance and Corrective Action 3
M Does "Responsibility" need to be mentioned in the Corrective Actions ? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
P Can the Auditor close down the Corrective Actions? Internal Auditing 12
J Methods to control Efficiency of Corrective and Preventive Actions Quality Manager and Management Related Issues 9
J Corrective and Preventive Actions Database in Excel Document Control Systems, Procedures, Forms and Templates 14
M Management Team "Actions" vs. CAPA (Corrective Actions) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
M Free webinar on Corrective and Preventive Actions on Thu, Mar 7, 2013 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q Measuring Monthly Progress in Corrective Actions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
E SPC Corrective Actions - Best Practice with Process Statistical Analysis Tools, Techniques and SPC 2
I RPN without Recommendation neither corrective actions FMEA and Control Plans 2
W Severity Rating CORRECTIVE ACTIONS - Opinions Wanted Please Nonconformance and Corrective Action 15
T System Corrective Actions when Conforming Product depends heavily on Inspection Nonconformance and Corrective Action 3
S Scoring the "Quality" of Planned & Executed Corrective & Preventive Actions? Benchmarking 3
Q Corrective and Preventive Actions and Management Reviews ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
0 Corrective Actions - Communication Management & Tools Preventive Action and Continuous Improvement 1
J Reviewing Effectiveness of Corrective Actions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
R Problems with Supplier - Always with 100% Sorting - No Corrective Actions Supplier Quality Assurance and other Supplier Issues 22
T Visually Presenting Effectiveness of Multiple Corrective Actions Nonconformance and Corrective Action 4
M Supplier Defective Product Return and Corrective Actions. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
T Drop Down ("Standard") Categories for Corrective Actions & Root Cause Nonconformance and Corrective Action 4

Similar threads

Top Bottom