Effectiveness Plan for CAPA initiated from External Audit

Q

QACen

#1
Hello,

A CAPA has been generated as a result of an external audit. We completed the action items as planned. I am just not sure what to do with the Effectiveness Plan section of this CAPA. The action items involved updating the MDR/Recall procedure to clarify the process based on regulations. It is not like we do MDRs or recalls frequent enough for me to check if it would be effective (actually going through the revised process). Verifying if procedures were updated and people were trained is not really effectiveness checks. For something to be effective, I would look to the next external audit on this area which can be a year or two. Any recommendations or direction that someone can give me?

NOTE: We are a medical device company.
Thanks!
 
Elsmar Forum Sponsor

Alpine

Involved In Discussions
#2
You could try carrying out a mock recall to assess the effectiveness of the actions implemented. I have always been of the view that mock recalls should be carried out at least annually to test systems, and ensure that all key stakeholders understand what is expected of them.
 
Q

QACen

#4
Mock trial, eh? I have never thought (or had the luxury to do so) of doing that. Thanks for the tip.
 
Thread starter Similar threads Forum Replies Date
K DCP (dynamic control plan) and PFMEA - Effectiveness of the DCP method FMEA and Control Plans 6
C Quality, efficiency and effectiveness of daily work routines Misc. Quality Assurance and Business Systems Related Topics 4
V CAPA effectiveness check Nonconformance and Corrective Action 3
N How to monitor the effectiveness of the CAPA system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
qualprod ISO 9001 5.1.1 - How to measure System effectiveness ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
qualprod Add new action plans in CA, while waiting effectiveness - Same problem reappears ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
qualprod Best criteria to measure Corrective Action effectiveness - Poor Maintenance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C CMDR Essential (Safety & Effectiveness) Requirements Checklist? Canada Medical Device Regulations 9
J AQL for Effectiveness Check - What AQL tiers to use on this type of sampling? Nonconformance and Corrective Action 9
M Medical Device News FDA - Transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices Other US Medical Device Regulations 0
S Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness ISO 13485:2016 - Medical Device Quality Management Systems 13
J Recall Effectiveness - Accessory to Medical Devices shipped through Distributors Customer Complaints 3
qualprod To Evaluate Effectiveness in All Improvements? (ISO 9001:2015) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Corrective Action Effectiveness Nonconformance and Corrective Action 5
Uriel Alejandro Evaluation of the effectiveness of correction actions General Auditing Discussions 15
L Verifying training effectiveness for procedure changes ISO 13485:2016 - Medical Device Quality Management Systems 4
T Hot dogs and process operation and control effectiveness? 4.1.3 a) ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 9001:2015 4.4.1 (c) Process Effectiveness ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
M Effectiveness Measuring and Efficiency Measuring In ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A IATF 16949 - Non-conformity on 5.1.1.2 Process effectiveness and efficiency IATF 16949 - Automotive Quality Systems Standard 5
S What are some ways to demonstrate Effectiveness of Training? ISO 13485:2016 - Medical Device Quality Management Systems 29
B IATF 16949 Cl. 7.3.2 - Documented Process (Effectiveness & Efficiency) IATF 16949 - Automotive Quality Systems Standard 7
R Documenting Self-Training and Effectiveness - ISO 13485:2016 Training - Internal, External, Online and Distance Learning 4
B Auditing Senior Management to determine the Effectiveness of Management Processes IATF 16949 - Automotive Quality Systems Standard 6
J Process Effectiveness and Efficiency (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 29
P Is ISO 9001 Model tested for its effectiveness by ISO before its release? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Do people read PEARS (Process Effectiveness Assessment Report)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
B IATF 16949 Cl. 9.3.2.1 - Management Review Inputs - Process Effectiveness and Efficie IATF 16949 - Automotive Quality Systems Standard 14
Colin Effectiveness of IRCA Registered Training ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
R ISO 13485:2016 Clause 6.2 - Effectiveness Check ISO 13485:2016 - Medical Device Quality Management Systems 1
Q Evaluating Effectiveness of a Preventive Action after Closure Preventive Action and Continuous Improvement 7
M Training Effectiveness TS 16949 Clause 6.2.2c Training - Internal, External, Online and Distance Learning 5
Q Corrective Action Effectiveness also for correction? Nonconformance and Corrective Action 11
S AS9100C 8.2.2 - Selected Tools & Effectiveness of IA Process and Performance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Performance vs. Effectiveness - ISO 9001:2015 par. 9.1.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S How to Monitor Training Effectiveness Training - Internal, External, Online and Distance Learning 13
Buckyb Are KPIs a requirement to determine Process Effectiveness? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
M Auditing ISO9001/AS9100 7.3 Design and Development Quality System Effectiveness Manufacturing and Related Processes 12
I Not having "effectiveness" in the Quality Policy ISO 13485:2016 - Medical Device Quality Management Systems 8
M Can OEE (overall equipment effectiveness) exceed 100%? Manufacturing and Related Processes 2
A Effectiveness of Risk Control Measures ISO 14971 - Medical Device Risk Management 4
M Where does OEE (Overall Equipment Effectiveness) belong? Quality Tools, Improvement and Analysis 11
R The Value and Effectiveness of In Process Inspection Quality Manager and Management Related Issues 17
L OEE (Overall Equipment Effectiveness) and Cost Savings Manufacturing and Related Processes 2
G 510(k) Pre-market approval Application Requirements - Effectiveness of the product Other US Medical Device Regulations 1
S ISO9001:2008 - Effectiveness Tracking for Nonconformance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Metrics on effectiveness of Customer Returns Misc. Quality Assurance and Business Systems Related Topics 9
J Reviewing Corrective Action Effectiveness ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Sean Kelley Can Goals be both Efficiency and Effectiveness? TS 16949 IATF 16949 - Automotive Quality Systems Standard 9
S Measuring OEE (Overall Equipment Effectiveness) for each Job, not for Machine Lean in Manufacturing and Service Industries 2

Similar threads

Top Bottom