Refusing to Show Management Review Records or Minutes

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#11
I was looking through this old discussion and started wondering. Has anyone here run into anything like this lately?
 
Elsmar Forum Sponsor
#12
Marc said:
I was looking through this old discussion and started wondering. Has anyone here run into anything like this lately?
Nope.

On the recieving end, we show what we have, trusting the auditor to shut up about any sensitive information.

When auditing someone else, they invariably show us the minutes, trusting us to shut up about any sensitive information.

Not a problem...

/Claes
 

RoxaneB

Super Moderator
Super Moderator
#13
Not a problem at this end, either. There is that wonderful concept about confidentiality regarding the audit's results. If sensitive information, such as the succession plan, is to be shown during the External Audit, I simply leave the room. During Internal Audits, I have made it the rule that performance appraisals can not be viewed by us - it is up to HR to demonstrate that an effective process has been established.
 
A

Aaron Lupo

#14
This is my take as an auditor. I have signed a Confidentiality Agreement prior to the audit. With that being said, I also ask them prior to the Management Review if there is any sensitive information they may not want me to see. If they say yes, I will review their procedure for Mgmt Review (99.9% of companies do have one) and see what it states as far as records, attendance sheets, action/follow up actions, agenda’s etc.. that I can review to support the fact that Mgmt review are taking place. I have not been told yet that I can’t review the minutes to the meeting.

Now, this is what we do where I work. We will show the Mgmt Review Records to our Registrar and Customers but not to the FDA. For our Registrar and Customers if there is any sensitive material we do not want them to see we will sanitize (black it out) a copy of the minutes prior to handing them over and explain why we did it, it has yet to cause any problems. The only thing we show the FDA is the agenda for the meeting to show what issues/systems were discussed and the sign in sheet to show who was in attendance.

Just a thought look at it from the auditors prospective, if you refuse to show any supporting documentation the review is being completed (agendas, sign in sheets, minutes (sanitized)), it gives the impression you are trying to hide something or that you are not doing what you say you are doing.
 
#15
I have run into this from time to time with internal auditors. It goes along the same lines as having an internal auditor looking over the business plan. Some organizations do not want their employees to know everything. The old mushroom treatment. :nope:
 
C

CINDY

#16
During our audits, we show all the meeting minutes that are for general viewing by all managers. When minutes contain confidential information, a special password is attached in order to open the document. Only individuals having the password may view the document (Generally the president and one or two managers). Those types of minutes are very few in-between. I have never had a problem with this. The general minutes not password required to open cover more than enough action by management to verify the activity. We have also electronically sent copies of minutes to customers (upon request) to audit our systems. Generally, any confidential information is removed. Well, we all make mistakes and adding the password to open the document helps to ensure they cannot view it if it was sent accidentally. Again, the minutes of confidential nature are password protected to prevent viewing by anyone without the password. I should add that our system is on a company wide intra-net where everyone is encouraged to view the documents. I should also note that even confidential information is limited to what is documented. Specific secrets may be discussed by never documented in such a form as to give the secret away.

In addition, of course, our minutes include the attendees, as it should.

Even our internal auditors must view management review meeting minutes to verify conformance.

Our minutes are just minutes and give an overview or brief descriptions of information or activities, not exacting detail.

I would question our or any auditor for that matter, if they did not want to view meeting minutes and a business plan to verify activity.

The same goes for the Business Plan. We may not post our business plan for everyone in the company to view, but we do communicate information from the business plan that everyone within the company needs to know. Our auditor has viewed our business plan and our methods of communicating it. He views what he needs to and has not viewed exacting details but rather views data such as the executive summary of the business plan. That executive summary is verified by the communication and participation throughout the company.

Just MHO or 2 cents worth.

Cindy
 

SteelMaiden

Super Moderator
Super Moderator
#17
If our internal or Regitrar's auditors ask to see our management review and/or minutes, we show them. They have signed a confidentiality agreement.
I do not show these things to customers unless it is a very quick flash of "here are the reports, here are the minutes, there may be things in these files that are sensitive for our customers, and I am sure you can appreciate the fact that we do not show your competitors information about your company." I've never had anybody push on this subject. The same goes for business plans. They see our goals, that is enough.

To take it a step further, any customer can have a copy of our quality manual, but I do not give copies of our procedures, work instructions or forms to our customers either. They can view them while they are here, but the documents never leave our premises.
 

Wes Bucey

Quite Involved in Discussions
#19
CINDY said:
During APQP activities, our customers regularly ask for copies of our procedures. How do you get around this?
I'm not sure what your objection is.
Do you fear giving away trade secrets on how you perform a particular operation?
If so, compartmentalize those in a work instruction which is NOT available for outsiders to view.

Rarely have I ever seen an outsider (registrar or customer) want to delve into work instructions, other than to verify they refer to the latest revision of a product or process.
 

SteelMaiden

Super Moderator
Super Moderator
#20
Cindy,

I just tell anyone who asks for copies of procedures or work instructions that they are welcome to see them while they are on site, but our policy is that copies are not sent off-site. It helps that we have our document control program set up to view all documents, but to print none. So, instead of using the web browser to show customers the procedures, we show them using the document control database.
 
Thread starter Similar threads Forum Replies Date
A Supplier refusing to be Audited Supplier Quality Assurance and other Supplier Issues 16
Ajit Basrur Guidance for Industry - Delaying, Denying, Limiting, or Refusing a Drug Inspection US Food and Drug Administration (FDA) 3
Q Faking Data - Refusing to sign Falsified PPAP Submission package Nonconformance and Corrective Action 27
S HR Manager refusing to create Quality Objectives - Is this a Non-Conformity? Quality Manager and Management Related Issues 11
W Audit Findings - Refusing outside audit findings Internal Auditing 14
Nihls When the MSA results show no operator influence Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 2
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 2
R How to SHOW the importance of checklists, through some team gaming or play? Training - Internal, External, Online and Distance Learning 37
Wes Bucey International Manufacturing Technology Show - 10 September 2018 - Chicago (meet up?) Coffee Break and Water Cooler Discussions 6
S What records are required to show compliance to ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 1
K Questions on Technical File to show it is current EU Medical Device Regulations 5
D How do I show compliance to RoHS, REACH and Conflict Minerals? REACH and RoHS Conversations 6
K Operator Checks - How to show that they were completed on a checklist as acceptable IATF 16949 - Automotive Quality Systems Standard 2
M Metric/Way to show how Internal DPPM and External DPPM relate to each other Nonconformance and Corrective Action 1
R Is it legal to attend a trade show while you have a 510(k) application pending? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Presentation displays for malls, etc. for exhibition to show products Coffee Break and Water Cooler Discussions 5
D Medica show in Dusseldorf - Has anyone else gone? Other Medical Device and Orthopedic Related Topics 3
W How to show compliance to multiple CE Directives ? CE Marking (Conformité Européene) / CB Scheme 4
T Is there a requirement in TS16949 that PO's show a revision level? IATF 16949 - Automotive Quality Systems Standard 3
S Which non Salmonella organisms show positive in Wellcolex? Test kit ? US Food and Drug Administration (FDA) 1
C Do I need to show fasteners in my BOM's/DMR etc? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
G What is needed to show competency Clause 6.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
W DIN ISO 1101 - Show me the General Dimensioning Tolerance Value Other ISO and International Standards and European Regulations 3
M Unapproved System Display at a Mexican Trade Show Other Medical Device Regulations World-Wide 2
L CE Auditor Using ISO audit reports to show compliance to the MDD?? EU Medical Device Regulations 4
P Is it necessary to show Model Number on the Labeling (meter box, label and manual)? Other US Medical Device Regulations 3
Hershal Reality TV show contest Coffee Break and Water Cooler Discussions 1
AnaMariaVR2 Design of Experiments in a Cooking Show Coffee Break and Water Cooler Discussions 0
T How to Show "Date/time" Data Graphically in Minitab Please? Using Minitab Software 2
S Suggested process to show compliance for this 820.120(a) for Label Integrity 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R How do we show our Software Develoment Life Cycle is similar to IEC 62304 Other US Medical Device Regulations 3
L Old and New Primary Standards show a difference between them General Measurement Device and Calibration Topics 9
Marc Questions about the Internet circa 1994 on NBC's "The Today Show" After Work and Weekend Discussion Topics 1
V Can we show Photocopied Uncontrolled Copies of Documents to an FDA Auditor? US Food and Drug Administration (FDA) 15
H Can anyone show me a sample of a Cleaning Program for Food Manufacturing? Food Safety - ISO 22000, HACCP (21 CFR 120) 5
Ajit Basrur How to show percentage in an Excel graph? Excel .xls Spreadsheet Templates and Tools 13
P Rework Notification - Is it sufficient to show how we control rework process Manufacturing and Related Processes 1
Anerol C How I can show evidence that quality related activities are impacting the financials ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
L BSI Logo - Requirements when using the BSI logo to show certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Japan's PMDA Response to Question on Trade Show Display of Non-approved Device Japan Medical Device Regulations 9
P Must show Sub-Supplier details? Supplying a Tier 2 company IATF 16949 - Automotive Quality Systems Standard 7
JoCam How do I show the benefits of a QMS to the Design Team? ISO 13485:2016 - Medical Device Quality Management Systems 23
I In ISO 9001:2008 - Can we show an Internal Department as our Client/Customer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Marc Land a Million Show - Aviation Funny Stuff - Jokes and Humour 0
B Can somebody help me to show a 'delta-FMEA' example? FMEA and Control Plans 10
S How to show Approval for Documents and Training? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
V Competency - How I can show experienced operators are competent? Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom