SBS - The best value in QMS software

QSA 4.17.6 - Internal Quality Audits - Effectiveness of the corrective actions

C

Csaba

#1
There is a QSA point:
Internal Quality Audits 4.17.6
"Are there follow-up audit activities for recording and verifying the effectiveness of the corrective actions taken?"
How can I satisfy this point?
I'm waiting some concrete think.

------------------
 
Elsmar Forum Sponsor
D

Don Watt

#2
Basically you can cover this by re-auditing against the corrective actions implemented for any non-conformities.
a) have actions been implemented?
b) do they work?

If the answer to either is no, we generally raise the matter to the next level of responsibility.
Hope this helps.
 

barb butrym

Quite Involved in Discussions
#3
they are looking for more than 'closed? YUP>>>"

what did you do to close the CA? What evidence did you review? How did you come to that conclusion?

Don't tie your self into a regiment of activities. Leave it a comment block called something like "follow up activities"
and actually fill in what you did to make the decision to close the CAR...
examples:

reviewed training record xxx, yyy for the above mentioned reinforcement of the criteria.

reviewed ECO #xyz to procedure nnnnn rev z to show the required change was authorized and released.

Audited area XXXX for evidence of recurrance, no evidene was found. see report #yyyy

Did a dock audit of product xxx order #yyyy no issues found.

See attached photo of the zzzz area in question. The area no longer has piles of stuff....or what ever
 
J

Jim Biz

#4
Barb I agree comletley - toooo sad that my auditors would not --- Expected "Clear definitive wording for closure criteria...

We used for customer complaints- XX number of parts shiped during x number of months or days - no further customer complaints forwarded - closure applied.

Also for system corrections or management issues closure - they were looking for "can I see-it in a proven record Closure criteria" Changed this or that - audited on x date - no further problems found over (our choice) X number of days/months - basis for closure established.
 
C

Csaba

#5
Thanks for your help & concrete answer
Now this question is clear me,
we can close it

Originally posted by Csaba:
There is a QSA point:
Internal Quality Audits 4.17.6
"Are there follow-up audit activities for recording and verifying the effectiveness of the corrective actions taken?"
How can I satisfy this point?
I'm waiting some concrete think.
 
Thread starter Similar threads Forum Replies Date
Stuart Andrews QSA/Gap Analysis needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M QSA (Quality System Assessment) - QSA-3 2nd Edition, 2nd Printing QS-9000 - American Automotive Manufacturers Standard 3
G QS9-SC/QSA-SC QS-9000 - American Automotive Manufacturers Standard 3
M QSA-TE - Electronic version of the QSA_TE (2nd edition) QS-9000 - American Automotive Manufacturers Standard 3
L TES & QSA-TE QS-9000 - American Automotive Manufacturers Standard 2
L TES & QSA-TE QS-9000 - American Automotive Manufacturers Standard 2
S Would this be a second site for the purposes of internal and third party audits? General Auditing Discussions 4
V Internal Auditor Competency KPI IATF 16949 - Automotive Quality Systems Standard 14
J ISMS - Internal Audits IEC 27001 - Information Security Management Systems (ISMS) 2
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
S ISO 9001:2015 Internal Auditing Internal Auditing 8
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Documented Information in Internal Audits Process (9.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
salaheddine96 Internal audit planning Internal Auditing 2
D CB and customer audits considered as internal audits? General Auditing Discussions 9
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
E MDR internal audit Medical Device and FDA Regulations and Standards News 0
B Internal Auditor Competency - Product Auditors Internal Auditing 9
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
F Internal transfer of work from one line to another? Qualification and Validation (including 21 CFR Part 11) 3
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
R Monitor production quality - Internal KPIs Manufacturing and Related Processes 5
R IATF 16949 - Outsourcing of internal audits Internal Auditing 10
M Major vs. Minor for Internal Audits? Internal Auditing 10
T Internal Nonconformance procedure thoughts (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Tips on preparing for IATF 16949 Internal Lead Auditor exam Manufacturing and Related Processes 1
C Internal Audits in a tiny Dx Company Internal Auditing 33
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
Q Internal audit plan template Internal Auditing 7
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 24
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M Help me improve the definition for internal PPM Manufacturing and Related Processes 3
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 17
S Risk based internal auditing Internal Auditing 6
O Informational Scaling back internal audits due to corona virus while avoiding a NC Internal Auditing 7
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
G Addressing Non-Conformances from an Internal Audit that are not product related ISO 13485:2016 - Medical Device Quality Management Systems 11
S Software for Supplier Charge back and internal PPM General Information Resources 2
G Internal Audits and Employee engagement Internal Auditing 16
I What direction do you provide your internal auditors on OFIs? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 3
F AS9100D Internal auditing requirements Internal Auditing 11
B Internal and external auditor competency to CSR's IATF 16949 - Automotive Quality Systems Standard 20

Similar threads

Top Bottom