Management Representative is NOT a member of Management

K

kp2001

#1
I'm hoping to get some help here from the professionals........

In our most recent external periodic audit we had a n/c written up against section 5.5.2. The individual we identified as the MR is NOT a member of management.

We have submitted to CAs that have been rejected.

The real root cause is that we made a conscious decision to ignore this portion of the standard. We didn't feel it was important enough when compared with our issues with document control, tool calibration etc etc.

I'm trying to avoid submitting this as root cause because I don't know what the corrective action would be to directly address the RC and prevent recurrence.

I need some help, advice, opinions or whatever I can get. Thank you.
 
Elsmar Forum Sponsor
#2
Re: Management Representative

I dont believe the MR has to be a member of management, but it certainly helps, as they need access to the executive part of management. This looks strange when one of the welders wants to sit down and chat in the CEO's office....
Usually the QA person is tagged with this hat also, but many variations are possible. The key is that the MR needs access to top management, or the job cannot be effective.
 

Stijloor

Staff member
Super Moderator
#3
Re: Management Representative

I'm hoping to get some help here from the professionals........

In our most recent external periodic audit we had a n/c written up against section 5.5.2. The individual we identified as the MR is NOT a member of management.

We have submitted to CAs that have been rejected.

The real root cause is that we made a conscious decision to ignore this portion of the standard. We didn't feel it was important enough when compared with our issues with document control, tool calibration etc etc.

I'm trying to avoid submitting this as root cause because I don't know what the corrective action would be to directly address the RC and prevent recurrence.

I need some help, advice, opinions or whatever I can get. Thank you.
Root cause: Top Management failed to recognize that the Management Representative must be a member of the organization's management.

Go with this, and that's it. Sometimes we have to owe up to our sins... :)

Stijloor.
 
#4
Re: Management Representative

The real root cause is that we made a conscious decision to ignore this portion of the standard. We didn't feel it was important enough when compared with our issues with document control, tool calibration etc etc.
Oh dear....
 
S

Sorin

#6
Re: Management Representative

Root cause: Top Management failed to recognize that the Management Representative must be a member of the organization's management.

Go with this, and that's it. Sometimes we have to owe up to our sins... :)

Stijloor.
What he said.

As corrective action: training

Or maybe the root cause was missing adequate training for the interpretation of standard requirements.
 

Stijloor

Staff member
Super Moderator
#8
Re: Management Representative

What he said.

As corrective action: training

Or maybe the root cause was missing adequate training for the interpretation of standard requirements.
Nope, look at post #1, fourth paragraph..

Stijloor.
 
B

Bogie

#9
The real root cause is that we made a conscious decision to ignore this portion of the standard. We didn't feel it was important enough when compared with our issues with document control, tool calibration etc etc.
If your mission was to find out if your auditor was paying attention, I guess you got your answer. :bonk:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
The real root cause is that we made a conscious decision to ignore this portion of the standard. We didn't feel it was important enough when compared with our issues with document control, tool calibration etc etc.
While you must be commended for the honesty in saying that, can you imagine if each organization around the world would take this approach? If they disagreed with the relevance and/or importance of a specific requirement of the standard, they could disregard it. The end result? A standard that is "selectively paid attention to", or a standard that isn't.

If followers of a standard decide to apply the buffet approach to the requirements, picking and choosing only the parts of the standard that make sense for them, the whole concept of standardization would vanish.
 
Thread starter Similar threads Forum Replies Date
T Management Representative - Member of Management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
Q Quality Management Representative - Does the QMR HAVE to be a member of management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M Management Representative - Shall appoint a member of the suppliers own management Other ISO and International Standards and European Regulations 6
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 11
L ISO 13485 5.5.2 - Can a consultant be our Management Representative ISO 13485:2016 - Medical Device Quality Management Systems 5
R Who is the Management Representative in my company? ISO 13485:2016 - Medical Device Quality Management Systems 7
S API Spec Q1 - How to define Management Representative competency for QMS Oil and Gas Industry Standards and Regulations 12
S Is management representative a temporary post or a job title Management Review Meetings and related Processes 16
S Management representative transition checklist IEC 27001 - Information Security Management Systems (ISMS) 7
J AS9100D Management Representative AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
P How to identify the Management Representative ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Audit of Management Representative Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
S Quality Management Representative confusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
L Who should be appointed as the Management Representative? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T Changes in ISO9001:2015 to the requirements for a management representative ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C AS9100 Management Representative - Can it be an outsider? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
M Is a Management Representative still needed for ISO 13485:2015? ISO 13485:2016 - Medical Device Quality Management Systems 7
K Difference between being a Management Representative and being a Lead Quality ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Management Representative is an Accountant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
T ISO 9001:2008 Management Representative and other Management Staff ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 31
x-files Matrix for: Established, implemented, maintained (5.5.2 Management Representative) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
E Do I need to notify the FDA of Management Representative changes? Other US Medical Device Regulations 3
K Management Representative Responsibilities for Multiple Standards Misc. Quality Assurance and Business Systems Related Topics 11
R Distinction between Management Representative vs. Quality Manager Responsibilities IATF 16949 - Automotive Quality Systems Standard 5
eternal_atlas Audit of Management Representative Functions (ISO 9001 & OHSAS 18001) Occupational Health & Safety Management Standards 9
A Management Representative and Information Security Officer for ISO27001 IEC 27001 - Information Security Management Systems (ISMS) 3
M Is Management Representative a loose cannon or am I unnecessarily concerned? Quality Manager and Management Related Issues 6
G Management Representative as Lead Auditor within a Company Internal Auditing 6
K Selection Criteria for choosing a Management Representative for QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
S Management Representative Requirements and Responsibilities Clarification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Can one Management Representative operate between two sister firms ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 55
P Level of Management Representative in Organization Chart Quality Management System (QMS) Manuals 5
P Level of Management Representative in an Organization Chart Misc. Quality Assurance and Business Systems Related Topics 4
M New QMR (Quality Management Representative) in need of advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V Is a Quality Representative (Management Representative) Designee Required? Management Review Meetings and related Processes 22
K More than One Management Representative? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Who does the Management Representative Report To? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
S Work as a QMR (Quality Management Representative) Quality Management System (QMS) Manuals 5
B Small Companies and the ISO 9001 Management Representative ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 31
B Management Representative Responsibilities Misc. Quality Assurance and Business Systems Related Topics 17
E AS9100 - Is the Management Representative a Top Manager? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
N Management Representative - Specific Training Required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 46
A MR (Management Representative) also doing Internal Audits? Internal Auditing 27
C Can an MR (Management Representative) be a Document Controller as well? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
J Management Representative Requirements - ISO 9001 - 5.5.2 Clarification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Z Involvement of Management representative (ISO 3834) in Quality Department Misc. Quality Assurance and Business Systems Related Topics 7
L Management Representative - 2 Person Device Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
A What is criteria to be Management Representative (MR)? Is there any standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
W MR (Management Representative) Requirements and Responsibilites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Management Representative - Example procedure needed Document Control Systems, Procedures, Forms and Templates 20

Similar threads

Top Bottom