Auditor says 5.6.3 should be discussed in Management Review

Jim Wynne

Staff member
Admin
#11
Jimmy,

By any chance did the top managers suggest their management system was inadequate, unsuitable or ineffective?

That or other evidence may have suggested insufficient resources per 5.1e or 6.1. 5.6.3 is way too exotic for most corrective action teams.

John
The question at hand is not whether there were insufficient resources. If an auditor saw evidence of that, the NC should cite the appropriate requirement(s). The question is whether or not the need for resources was a topic of management review, and if not, whether resource needs must be addressed in management review output.
 
Elsmar Forum Sponsor

jimmymustang06

Involved In Discussions
#12
This is from the auditors NCR

Requirement: Clause 5.6.3 of the ISO/TS 16949:2009 Standard states that the output from the management review to include decisions and actions related to resource needs.

Objective evidence: The December 23, 2013 management review meeting minutes did not show that decisions and actions related to resource needs. Since other management review requirements had been met, this NC is classified as minor.



 

Jim Wynne

Staff member
Admin
#13
This is from the auditors NCR

Requirement: Clause 5.6.3 of the ISO/TS 16949:2009 Standard states that the output from the management review to include decisions and actions related to resource needs.

Objective evidence: The December 23, 2013 management review meeting minutes did not show that decisions and actions related to resource needs. Since other management review requirements had been met, this NC is classified as minor.



The auditor should quote the requirement verbatim, and this is a good example of why. The requirement says "...shall include any decisions and actions..." That little word "any" makes a difference.
 
Last edited:

John Broomfield

Staff member
Super Moderator
#14
Jimmy,

Thanks for posting the actual NC statement,

The auditor is inventing a requirement to record no decision and no actions related to resource needs.

Complete BS, especially after top management has agreed that their management system remains suitable, adequate and effective.

John
 

insect warfare

QA=Question Authority
Trusted Information Resource
#15
Thanks all.. just had the closing meeting, the auditor is sticking with his minor finding that "resource needs" was not found on the management review notes... I don't have the "official" language yet, tried arguing it by saying it is an output and no conversation was held or decision made concerning needing more resources,.. I said "now if we had made a decision and I didn't have that decision in my notes, that would be a finding"..... he said we would have to appeal.
Thanks for posting the auditor's statement.

One more thing to consider is, when recording management reviews, that the outputs from 5.6.3 are kind of married together as actions and decisions, and are not viewed as separate entities in every instance. This is intended to convey that resource needs (c) are usually considered in order to ensure outputs (a & b) are realized. You should be able to appeal the finding on these grounds....

Using this logic in a "Roadhouse" type scenario, if you have identified actions and decisions from your review (e.g. get rid of all the corrupt bouncers at the Double Duece), you are likely addressing the fact that resources are needed anyway (a new cooler, replacement bouncers, different rules and regulations, etc.). This should be perfectly acceptable. But if this exercise is taken too far, it can turn into the equivalent of a preposterous Christmas wish list (let's get Sam Elliott and Patrick Swayze in here tomorrow) - whether you can get those resources is probably another issue that (if inadequate) should be cited under 6.1 and 6.2 instead.

Brian :rolleyes:
 

John Broomfield

Staff member
Super Moderator
#16
Brian,

Love it! :lmao:

But top management waiting for their review of system performance may be too late for dealing effectively with these operational problems.

MR invoking PARs and CARs may result in better planning and any necessary system improvements.

Much better than "minutes of meeting".

John
 
Q

qualityboi

#17
I agree 100% with the auditor. We must demonstrate that all topics in 5.6 are covered in the management review. If we have no evidence, then we cannot demonstrate comliance, in a audit we are guilty until proven innocent. So I disagree with anyone that thinks that if no action is decided upon you can leave the record blank. The MR record needs to show evidence of review, if no action is needed, then document "no action needed at this time" or something to that affect.

For example 4.1b indicates the company must determine sequence and interaction. How is that demonstrated? - By having process maps or flow charts, no where in the standard does it state that but it has become an expecation of demonstrating compliance. Try to get through an ISOTS16949 audit not using the AIAG FMEA format or WECO rules for SPC and you will get a finding 99% of the time. However, no where does it state in the standard that you must use that particular format. No where in the standard does it state that everyone must follow procedures, but it is implied and it is upon the auditee to demonstrate it.

The best recommendation I coud give is that you have a Management Review meeting minutes formatted to requirements of 5.6 or at least a part of the MR is formatted verbatim to it and then document evidence that each item was reviewed or if skipped with a reason why.

Our company approaches registar audits by linking evidence to demonstrate compliance to every clause in the standard as an internal reference for to not only practice for registrar audits but also as an input reference for Quality Manual.

There are a myraid of items in the standards that imply or expect a certain type of evidence to demonstrate compliance.

Regards,

Jim
 

Jim Wynne

Staff member
Admin
#18
I agree 100% with the auditor. We must demonstrate that all topics in 5.6 are covered in the management review. If we have no evidence, then we cannot demonstrate comliance, in a audit we are guilty until proven innocent.<snip>
An auditor may review the details of management review and if resource needs are part of it, the output will (or should) address the need in some way. On the other hand, if there is no evidence of resource needs (a) being part of the review and or (b) being necessary, there is no nonconformity.

I will also disagree with your "guilty until proven innocent" contention. In fact, the opposite is true; the working assumption should be that the QMS is compliant, if there is any assumption made at all. We need to be able to provide evidence for what's been done, not for what hasn't been done.
 

Wes Bucey

Quite Involved in Discussions
#19
I agree 100% with the auditor. We must demonstrate that all topics in 5.6 are covered in the management review. If we have no evidence, then we cannot demonstrate comliance, in a audit we are guilty until proven innocent. So I disagree with anyone that thinks that if no action is decided upon you can leave the record blank. The MR record needs to show evidence of review, if no action is needed, then document "no action needed at this time" or something to that affect.

For example 4.1b indicates the company must determine sequence and interaction. How is that demonstrated? - By having process maps or flow charts, no where in the standard does it state that but it has become an expecation of demonstrating compliance. Try to get through an ISOTS16949 audit not using the AIAG FMEA format or WECO rules for SPC and you will get a finding 99% of the time. However, no where does it state in the standard that you must use that particular format. No where in the standard does it state that everyone must follow procedures, but it is implied and it is upon the auditee to demonstrate it.

The best recommendation I coud give is that you have a Management Review meeting minutes formatted to requirements of 5.6 or at least a part of the MR is formatted verbatim to it and then document evidence that each item was reviewed or if skipped with a reason why.

Our company approaches registar audits by linking evidence to demonstrate compliance to every clause in the standard as an internal reference for to not only practice for registrar audits but also as an input reference for Quality Manual.

There are a myraid of items in the standards that imply or expect a certain type of evidence to demonstrate compliance.

Regards,

Jim
If your "mission creep" were adopted by all organizations, there would be a lot of wasted time, money and effort documenting nonevents ("there was NO FIRE today, so we DID NOT deploy fire extinguishers, call fire department, or evacuate personnel.")

An auditor may review the details of management review and if resource needs are part of it, the output will (or should) address the need in some way. On the other hand, if there is no evidence of resource needs (a) being part of the review and or (b) being necessary, there is no nonconformity.

I will also disagree with your "guilty until proven innocent" contention. In fact, the opposite is true; the working assumption should be that the QMS is compliant, if there is any assumption made at all. We need to be able to provide evidence for what's been done, not for what hasn't been done.
Yes. Show us the shall for "guilty . . ."
 

insect warfare

QA=Question Authority
Trusted Information Resource
#20
MR invoking PARs and CARs may result in better planning and any necessary system improvements.

Much better than "minutes of meeting".

John
I agree with you here. The auditor referred to in this thread should have also been looking beyond the management review "minutes" for evidence that resource needs were considered (if it didn't occur to him to do so). Reviewing PA's and CA's that were tied to the management review would have provided a good trail to follow.

Brian :rolleyes:
 
Thread starter Similar threads Forum Replies Date
S Auditor says a Minor Nonconformance will become a Major Nonconformance General Auditing Discussions 8
G Dangerous Act - Auditor says major nonconformance for safety (risk) issue Occupational Health & Safety Management Standards 21
E FMEA Action Plan Threshold (RPN) - Auditor says Action Plan for an RPN > 84 IATF 16949 - Automotive Quality Systems Standard 21
tony s Auditor says our Quality Manual is deficient. What can you say? Quality Management System (QMS) Manuals 58
B Medical Device Directive 93/42 EEC - Clinical Trials - Because the auditor says so? ISO 13485:2016 - Medical Device Quality Management Systems 18
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
W Redacting Info Before Giving to Auditor ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T Quality auditor legal right to see Board meeting minutes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
V Certified Auditor - Need of additional certification specific to industry ( GMPs) ASQ vs ECA vs others Professional Certifications and Degrees 1
V Internal Auditor Competency KPI IATF 16949 - Automotive Quality Systems Standard 14
R American Petroleum Institute - Becoming an API Auditor Professional Certifications and Degrees 2
B Lowest cost way to pass Lead Auditor exam ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
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
Z Auditor Findings ISO 14001:2015 vs. 45001:2015 ISO 14001:2015 Specific Discussions 6
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
A Becoming an ISO27001 3rd Party Auditor Career and Occupation Discussions 4
L ASQ's Biomedical Auditor Course Test ASQ - American Society for Quality 1
M Tips on preparing for IATF 16949 Internal Lead Auditor exam Manufacturing and Related Processes 1
G Same parts but new customer - What will the auditor ask me? IATF 16949 - Automotive Quality Systems Standard 2
Gun46 ISO 9001 : 2015 Lead Auditor Exam General Auditing Discussions 16
K %GRR was between 10-30% so we have to have a "backup plan" per auditor IATF 16949 - Automotive Quality Systems Standard 15
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
R ISO 45001 Lead Auditor Exam paper Training - Internal, External, Online and Distance Learning 1
B Internal and external auditor competency to CSR's IATF 16949 - Automotive Quality Systems Standard 20
A Our auditor told if we didn't have a patent we would have to do a validation or verification ISO 13485:2016 - Medical Device Quality Management Systems 6
W Certification for IATF Lead Auditor will expire in 2020 IATF 16949 - Automotive Quality Systems Standard 2
D Impartiality of Internal Auditor ISO 9001/13485 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
Ed Panek Auditor driving us nuts - ESD requirements ISO 13485:2016 - Medical Device Quality Management Systems 23
A OHSAS 18001 external auditor finding personal interpretation? Occupational Health & Safety Management Standards 5
S IRCA Lead Auditor training and Exam tips Training - Internal, External, Online and Distance Learning 5
L ASQ CBA biomedical auditor - CBA primer material is enough to study? ISO 13485:2016 - Medical Device Quality Management Systems 6
B VDA 6.3 Qualification as Process Auditor training course and exam VDA Standards - Germany's Automotive Standards 0
F ISO 21001 Educational Organizations Management - How to become an auditor Other ISO and International Standards and European Regulations 1
J Getting training either from ASQ or from SAI Global - ISO 9001 Lead Auditor training Training - Internal, External, Online and Distance Learning 1
P ASQ Certified Biomedical Auditor (CBA) Certification Preparation 2019 ASQ - American Society for Quality 3
M Medical Device Design Control Auditor Recommentations General Auditing Discussions 19
G Third party auditor mentions no grace period for calibration Calibration Frequency (Interval) 22
D Where (in US) can I get the VDA Auditor Edition book? VDA Standards - Germany's Automotive Standards 3
S AIAG CQI Auditor Qualification and 3rd Party Certification Requirements General Auditing Discussions 2
M IATF 16949 7.2.3 Internal Auditor Competency - Trainer's competency Internal Auditing 7
C Recommendations for UK-based ISO 13485 internal auditor training ISO 13485:2016 - Medical Device Quality Management Systems 1
Sidney Vianna AS9100 News July 2019 AAQG/RMC CB Auditor Workshop - Presentation Materials AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
D Scope of Facility - Our auditor asked us last week for our "Scope of the Facility" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
A ISO 9001 lead auditor as Full time career India Career and Occupation Discussions 2
J Manufacturing Process Auditor Requirements - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 9
GreatNate ISO 9001:2015 Lead Auditor Course? (who to take with) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
A External Auditor issue with Internal Audits Internal Auditing 7
Q Internal Auditor competence for ISO 14001 ISO 14001:2015 Specific Discussions 11
S IATF 16949: Is "Certified" Internal Auditor mandatory? IATF 16949 - Automotive Quality Systems Standard 9

Similar threads

Top Bottom