Auditor says 5.6.3 should be discussed in Management Review

Jim Wynne

Staff member
Admin
#31
With all respects to the people who say " Show me the shall ", this is a shall requirement.
...The output from the management review shall include any decisions and action .....
Now, if it is a shall, it better be covered in the management review record.
If no decisions and actions., then record Nil.
Shall is met ... Any = Nil
Simple
Can you show me the "shall" regarding management review meeting minutes? The auditor specifically cited the meeting minutes. Suppose, just for the sake of discussion, that management review is comprised of the top manager reviewing the required inputs. It's apparent from that review that resources do not need to be addressed. There are other issues that come up in the review that have been addressed. There is no meeting, so there are no meeting minutes. Upon interviewing the top manager, an auditor is told what was reviewed and the results of the review. The results can be seen in some form. Is there a nonconformity here?
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#32
Can you show me the "shall" regarding management review meeting minutes? The auditor specifically cited the meeting minutes. Suppose, just for the sake of discussion, that management review is comprised of the top manager reviewing the required inputs. It's apparent from that review that resources do not need to be addressed. There are other issues that come up in the review that have been addressed. There is no meeting, so there are no meeting minutes. Upon interviewing the top manager, an auditor is told what was reviewed and the results of the review. The results can be seen in some form. Is there a nonconformity here?
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.
Objective evidence = What is seen as evidence during the audit.
If the evidenced management review record is called as December 23, 2013 management review meeting minutes by the client, so be it, and so is stated. It also states that other management review requirements has been met. Hence this is the record of management review. Everything else is our assumptions and additions.
 

Jim Wynne

Staff member
Admin
#33
Objective evidence = What is seen as evidence during the audit.
If the evidenced management review record is called as December 23, 2013 management review meeting minutes by the client, so be it, and so is stated. It also states that other management review requirements has been met. Hence this is the record of management review. Everything else is our assumptions and additions.
You didn't answer the hypothetical question, which has a bearing on the actual situation. If there is no requirement for meeting minutes, how can a nonconformity be derived from them?

You are correct about the possibility that there is other information we're not privy to at this point. Does the OP's organization have a documented procedure for MR? Did the auditor question anyone about the need or lack thereof for attention to resources? What's more important--having adequate resources or having a record of a meeting where the adequacy of resources wasn't even discussed?
 

Big Jim

Super Moderator
#34
You didn't answer the hypothetical question, which has a bearing on the actual situation. If there is no requirement for meeting minutes, how can a nonconformity be derived from them?

You are correct about the possibility that there is other information we're not privy to at this point. Does the OP's organization have a documented procedure for MR? Did the auditor question anyone about the need or lack thereof for attention to resources? What's more important--having adequate resources or having a record of a meeting where the adequacy of resources wasn't even discussed?
Minutes may not be required, but records are. I'm not going to enter into a debate as to what form those records need to be in or to what extent they need to be, but records are required.

Just for giggles let me throw in that a meeting isn't required. A review needs to take place and there needs to be records, but it doesn't need to be in the shape of a meeting.
 

somashekar

Staff member
Super Moderator
#35
You didn't answer the hypothetical question, which has a bearing on the actual situation. If there is no requirement for meeting minutes, how can a nonconformity be derived from them?

You are correct about the possibility that there is other information we're not privy to at this point. Does the OP's organization have a documented procedure for MR? Did the auditor question anyone about the need or lack thereof for attention to resources? What's more important--having adequate resources or having a record of a meeting where the adequacy of resources wasn't even discussed?
I did not answer because it was hypothetical ...
If I call my MR records as say 'minutes of deliberations with top management' then this can be stated in the NC statement as the objective evidence for MR records. We know about no meetings and no minutes of meetings are the requirements. But when a client calls the MR records by the name he is comfortable with, what is my problem ... ?
There is no other information, as it is very clear from what the OP states as the NC statement. It says all other requirements of the management review were met. This makes fact clear. We must keep our discussions to the management review and records, and not to other things what we feel is important.
 

Wes Bucey

Quite Involved in Discussions
#36
Minutes may not be required, but records are. I'm not going to enter into a debate as to what form those records need to be in or to what extent they need to be, but records are required.

Just for giggles let me throw in that a meeting isn't required. A review needs to take place and there needs to be records, but it doesn't need to be in the shape of a meeting.
If I understand you correctly, you are asking for records of null events such as
  1. we did NOT discuss or consider resources in our meeting [consideration for an important point raised by Jim Wynne] nor in our private thinking as we reviewed "management 'things'
  2. we did not consider retraining and re-evaluating any staff for competence since there were no issues in the past [day/week/month]
  3. we did not consider buying new capital equipment this month because we bought all new stuff last month
  4. we did not consider moving to a new, larger location
  5. we did not consider installing air conditioning [since it's 15 degrees below zero]
If so, it would seem to me we would need to add one more item to the list:
  1. We DID CONSIDER [and decide] that creating and maintaining all these null records were creating a drain on our resources of time, money, and energy
 

jimmymustang06

Involved In Discussions
#37
I'm wrestling with appealing it or just let it stand and add those points to my MR template. I currently have the inputs listed, upper mgmt and I discuss them one by one. We did not discuss anything that would require more resources (human or any other). We are a bulk material supplier so we do not design product. We are provided a print of a part by our customer and make that part for our customer. We are very heavily involved in CONTINUAL improvement, so much that we believe we are leaders in our particular industry, in which we use resources that we already have.

My fear is that I make a name for ourselves (not the good kind) with auditors of this registrar and it's taken out on us in the form of more findings. In this case, it was this auditor's 2nd day on the job with this registrar and he had his boss observing him. We ended up with 8 minors versus our average of, maybe, 2. I will request that this particular auditor not be used again.

We went through this sort of thing last year when the auditor was speaking from the section that deals with service parts? He wondered if we ever went to any of the local auto parts stores and inquired about problems that affect parts that include product that we make? We told him we do not make service parts. He wound up dropping that one and found two others.. :/
 
R

Reg Morrison

#38
My fear is that I make a name for ourselves (not the good kind) with auditors of this registrar and it's taken out on us in the form of more findings.
While your concern is understood, in my experience it is unfounded. Good registrars should appreciate feedback and NEVER allow a technical disagreement turn into some form of retaliation.

Also, remember, you pay their bills. They are the ones that are concerned in losing your account. While they should never compromise the integrity of their work to please a customer, they have to be interested in adding value if they are thinking of long term success.
 

Wes Bucey

Quite Involved in Discussions
#39
I'm wrestling with appealing it or just let it stand and add those points to my MR template. I currently have the inputs listed, upper mgmt and I discuss them one by one. We did not discuss anything that would require more resources (human or any other). We are a bulk material supplier so we do not design product. We are provided a print of a part by our customer and make that part for our customer. We are very heavily involved in CONTINUAL improvement, so much that we believe we are leaders in our particular industry, in which we use resources that we already have.

My fear is that I make a name for ourselves (not the good kind) with auditors of this registrar and it's taken out on us in the form of more findings. In this case, it was this auditor's 2nd day on the job with this registrar and he had his boss observing him. We ended up with 8 minors versus our average of, maybe, 2. I will request that this particular auditor not be used again.

We went through this sort of thing last year when the auditor was speaking from the section that deals with service parts? He wondered if we ever went to any of the local auto parts stores and inquired about problems that affect parts that include product that we make? We told him we do not make service parts. He wound up dropping that one and found two others.. :/
Please appeal! This is really "mission creep" and your organization's stand on this item will help make clear to registrar bosses that this is not acceptable practice by auditors. If you like, send me a pm with registrar , auditor, and NC details and I will make an amicus curiiae plea to the top registrar boss on your organization's behalf, but, more importantly, on behalf of the Quality Profession.
While your concern is understood, in my experience it is unfounded. Good registrars should appreciate feedback and NEVER allow a technical disagreement turn into some form of retaliation.

Also, remember, you pay their bills. They are the ones that are concerned in losing your account. While they should never compromise the integrity of their work to please a customer, they have to be interested in adding value if they are thinking of long term success.
YES!
 
Q

qualityboi

#40
Continous means without stopping or pausing so it is not condusive to Plan Do Check Act, as opposed to continual improvment.
 
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