Hit for not reviewing System Suitability in Management Review

D
#1
I took a hit for not reviewing system suitability in Mgmt. Rev. (QS). I am compiling a list of all elements with their procedures and work instructions to review each one in meeting. Does anyone have any other way to cover this?
Thanks, Dawn
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
You have me on this one. I've never heard of a company being cited for not reviewing suitability.

I pressure my clients to have a management review check list. One for ISO is in the Elsmar.com/pdf_files directory - file name is Mgmt_rev.pdf It was for ISO9000 but can be easily configured for QS. I put this form together some years ago because I got tired of auditors nit picking about each line item. I'm not convinced you have to address every single procedure and work instruction - my clients have told the auditor this is a general conversation / discussion - that suitability was a consideration throughout. For example, "...we eqach consider suitability of our systems during every meeting as a normal part of our reviews. We do not, however, have a special session or part of our meeting where we individually discuss at length suitability of each system, it's procedures and work instructions. When a meeting member feels a system or element of a system is no longer appropriate (suitable), s/he will bring it up as a specific topic. If we all concur it is put on our agenda as an action item and assigned to the appropriate employee."

If I was going to respond, I would put 'Suitabbility of existing systems' as 1 line item on the management review form. I see no requirement to go theough each system and each of their elements (procedures, WI's, etc.) individually during a management review meeting.

Did the auditor state his/her expectations? If not, I would contact him/her and ask. You might even get it in writing (a bit antagonistic, though).
 
D
#3
His exact words (in writing) were "No conclusions documented in management review records on suitability of the system."
My fix was "A breakdown of every element is provided to assure there is enough documentation; too much documentation; if processes are still acceptable; and if they are adequate for what we are doing."
This is what he wnats to see.
I will download the pdf file. Thanks!
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
As I said, the pdf file is a simple form. I press the form (check list if you will) idea on clients to reduce nit-picking opportunities. Thjat said, the auditor question will be" Explain what criteria you use..." or something like same. The form does make you address each issue during the meeting, however, if even briefly, so there you go!
 
#5
During our first ISO-9000 audit we were given a "concern" for the same thing. We solved this by stating that during our Annual Management Review meeting the Management Representive shall comment on his/her review of the Quality System in regards to its continued suitability and effectiveness in satisfying the requirements of...(see 4.1.3) A summary of these comments would then be captured in the meeting minutes. Remember to state what the conclusion of this review was within the minutes or you'll still get "dinked."
 
#6
Dawn,
I received one minor and four "observations" for not adequatly reviewing "suitability and effectiveness".
I was told by the auditors and also at a seminar I attended; presented by a registrar, that each element of the standard must be evaluated for continued "suitability and effectiveness" a minimumm of one time per year.
Suggested suitable means for evidence of review should be in the form of a checklist; questions referring to suitability and questions referring to effectiveness.
At first I thought this might be a liitle bit of overkill, however the standard does not say how to do it, just do it.
My question; Could this review be combined with the audit process. Establish an audit schedule such that at the closing meeting the suitability and effectiveness could be addressed.

Feedback any one.

By the way, Marc, I used your management review pdf at my last audit and received rave reviews from the auditor.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#7
Originally posted by Sam:
By the way, Marc, I used your management review pdf at my last audit and received rave reviews from the auditor.
It's just a simple 'helper' - I'm happy that it helped you!
 
Thread starter Similar threads Forum Replies Date
M Winds hit Nevada, US - 6 February 2015 Coffee Break and Water Cooler Discussions 6
B Any suggestion on creating the best paper plane that can hit a target perfectly? Coffee Break and Water Cooler Discussions 2
Stijloor German automakers' expansion plans hit by shortage of engineers World News 2
Q Where were you on 9/11/2001 when the world trade center got hit? Coffee Break and Water Cooler Discussions 28
tsmith7858 AIB International takes a Hit for PCA Audit Reports but everyone is impacted Food Safety - ISO 22000, HACCP (21 CFR 120) 4
somashekar Definition Near Miss - Definition of Near Miss (Hit) - OHSAS 18001 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 19
Stijloor Memo to bosses: Leave office, hit the streets World News 6
C 6061-T6 Aluminum - Any reason Heat Treat can't hit Minimum of RB/50? Supplier Quality Assurance and other Supplier Issues 12
D We had a worm or virus hit our network yesterday - a.exe worm After Work and Weekend Discussion Topics 7
E Half a Million U.K. Patients Are Hit Yearly by NHS Blunders World News 0
samer Hit ratio of customer satisfaction process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
Marc Survey shows that employee morale has taken a hit World News 3
Marc Ford Sales Drop, Rising Costs Hit Profit World News 0
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
K ISO 13485 section 5.3 Quality Policy - No framework for establishing and reviewing quality objectives ISO 13485:2016 - Medical Device Quality Management Systems 2
K Reviewing a supplier's ISO 9001 certificate issued for a future date Registrars and Notified Bodies 10
V Periodic review criteria for reviewing/updating SOPs US Food and Drug Administration (FDA) 1
H Extra checks to do when reviewing the batch records for release of products Records and Data - Quality, Legal and Other Evidence 2
J Reviewing Corrective Action Effectiveness ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
G Reviewing Process Effectiveness and Efficiency IATF 16949 - Automotive Quality Systems Standard 5
T Process for Reviewing Internal Data Quality Manager and Management Related Issues 1
J Reviewing Effectiveness of Corrective Actions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
A Need help with a Kappa Study (MSA) - Reviewing x-ray Images Six Sigma 11
J Cpk & Ppk - Reviewing a PPAP Package - Some questions Statistical Analysis Tools, Techniques and SPC 8
A Reviewing All Incidents for Trends & Opportunities Preventive Action and Continuous Improvement 5
A Audit NC for not collecting/reviewing feedback from Internal Customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
A Reviewing Documents - FDA Time Requirements? Document Control Systems, Procedures, Forms and Templates 1
Douglas E. Purdy What does 8.5.2 & 8.5.3 "reviewing ... action taken" mean? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H Clause 4.2 (d) intent - Framework for setting and reviewing environmental objectives Miscellaneous Environmental Standards and EMS Related Discussions 7
M Reviewing Corrective Action Status for effective Management Review Management Review Meetings and related Processes 5
R Reviewing Documentation in preparation for an Audit General Auditing Discussions 5
Q Errors in the AIAG's SPC manual? Need help reviewing charts. Statistical Analysis Tools, Techniques and SPC 8
Crusader 7.2.1 "Determine Requirements" vs. 7.2.2 "Reviewing Requirements" - Differences? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S ISO/TC 176 SC2 is now reviewing some minor changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Questions about defining/tracking/reviewing our goals/objectives - 8.4.1 IATF 16949 - Automotive Quality Systems Standard 8
B Reviewing corrective action - How to ensure that root cause analysis is correct Problem Solving, Root Cause Fault and Failure Analysis 5
C Current Receiving Inspection activities - Reviewing, revising and improving Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
R Methods of Reviewing Calibration Intervals Calibration Frequency (Interval) 2
K Biological indicator system classification under MDR EU Medical Device Regulations 2
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
R How would you work without a quality management system? IATF 16949 - Automotive Quality Systems Standard 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
D EQMS - When the internet or system might not be available ISO 13485:2016 - Medical Device Quality Management Systems 7
Ron Rompen MSA on automated measurement system - Multiple Step Vision System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
S Quality management system (Well head installation & maintenance) Quality Management System (QMS) Manuals 5
DuncanGibbons Model-Based procedures and Architecting the QMS as a System Document Control Systems, Procedures, Forms and Templates 2
P How to develop executable quality management system for rookies? IATF 16949 - Automotive Quality Systems Standard 10
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4

Similar threads

Top Bottom