Transition of Quality Management - Recently lost our Quality Manager

B

barbt

#1
Hello,

We have just recently lost our Quality Manager, and are planning on how best to fill the gap. As we go through this transition period, how long a 'grace' period - if any- can we expect from the registrars for getting documentation updated to reflect new ownership of responsibilities? - What has to be in place by 'tomorrow', and what could wait until the dust has settled? - Our next maintenance audit is scheduled for 6 weeks from now, so I have a bit of time to get the initial documentation changes made.

I am sure many of you have inherited positions from former QA managers. I would be most interested to learn how you handled the transition, what pitfalls to avoid, and the damage control that needs to be done right away.


Many thanks,
Barb
 
Elsmar Forum Sponsor
C

Craig H.

#2
barbt:

There are several considerations here, and many depend on how good a job the departed QM was doing.

One thing to look out for is documentation that mentions a person's name or initials. Now, I don't mean a signature, but within the document if "Sammy Quality" is mentioned instead of "Quality Manager", then those will all have to be changed.

In the cases where the departed QM has singed off on something, leave it in place. If he was the QM on the date the signature was made, it is OK.

It is going to take anyone new a while to learn what system is already in place. Since you mentioned a maintenance audit, I assume your system is presently in good shape. Then, in the interm, someone needs to be appointed for each of the areas (i.e. corrective action) that require ongoing attention.

You didn't mention if you have made the transition to 2000. If not, someone needs to start addressing that now.

Hope this helps.

Craig
 
J

Jim Biz

#3
Hmmmm??? much of this actually depends on the viewpoint of your specific registrar but without knowing any specifics within your particular system ......

If the documents were set-up in a maner that allowed smooth transition (IE using job titles to assign responsibilities instead of actual designated names) the transition should not be all that problematic

Resign & re-print the Master Hard copy - change/update the electronic copies and go from there.....

Be prepared to identify the Date the job was given to the "new Qa manager" and I would THINK any auditor would work with you on it :ca:

Hope this helps
 
T

tomvehoski

#4
You might want to have executive management issue a letter/memo stating who is taking over the responsibilities of the quality manager in the short term. If the duties are being split among several people, it will help explain why approvals may not look right against the documentation. I agree that if you are not using titles on procedures you should change, but the memo above will cover you in the short term.

I've had clients transition quality managers within a few weeks of an audit. It was looked on as corrective action / continuous improvement since the first QM was not doing a good job. Most auditors will be fine if there are some difficulties with the new person explaining things, as long as everything is still being done properly. Don't try to rely on "I didn't know we were supposed to do that since I am new." - If your procedures are good it will help the transition.

Tom
 
B

barbt

#5
My thanks to all of you who have replied.

The good news is that our documentation does reflect titles and not names, and that we are planning an announcement of official transition for this week.
In the cases where the departed QM has singed off on something, leave it in place. If he was the QM on the date the signature was made, it is OK.
- This is a relief, I was doing some heavy research into the QS9000 manual to see what is written with respect to management representative transition. I wasn't completely sure how this should be handled. It sounds like I have some breathing room until it's sorted out.

thanks,
Barb
 
A

Al Dyer

#6
Barbt,

I'm not sure how your systems work, but do you have a Management Represetative that should already be able to answer you question!:)
 
#7
Don't try to rely on "I didn't know we were supposed to do that since I am new."
This is an important note Tom. If your system is working properly, your new person should slide in rather seamlessly. Most auditors will give a little bit of slack in finding the evidence (knowing which file drawer it is in), but don't look for slack in knowing what was supposed to happen.

I'm not sure how your systems work, but do you have a Management Represetative that should already be able to answer you question!
Al raises a good point here. I think we are all assuming your Quality Manager and your Management Representative (MR) are the same person. This might not be the case, in which your MR should have things under control
 
R

RosieA

#8
Hi Barb,

I understand you dilemma, having been through the same scenario recently.

At the end of January, we went through a massive reorganization. Several departments went away to other facilities, and the Quality Director in my facility was laid off and the job transferred to a division 2000 miles away.

I'm the ISO Rep, so at least we didn't lose total track of how the QMS works here, but I had an ISO audit coming up which included several of the depts. we'd axed.

The very first thing I did was contact my assessor and explained what had just happened. That way he was prepared to come in and "punt" as it were.

Next I met with division management and asked them to do a review of the documents from the affected departments and put together a roadmap for reviewing, updating or withdrawing them. I knew it would be impossible to do everything before the audit, but a roadmap shows planning. Every company has periods like this where changes are happening quickly. As long as there is communication with the assessor and a control plan for how the changes will be handled, I don't think any reasonable auditor would take you to task. After all, by doing this you're demonstrating that you're controlling the integrity of your system during periods of changes, just as 5.4.2 requires.

My audit was earlier this week and it went fine.

Good luck!
 
Thread starter Similar threads Forum Replies Date
A Transition to Military from Automotive Quality Management Various Other Specifications, Standards, and related Requirements 5
R ISO 9001:2015 Transition Quality Manual Update - Redundant Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
T Has anyone completed the AS9100D Quality Manual transition? Quality Management System (QMS) Manuals 1
T Brexit Transition Arrangements & Import into the EU EU Medical Device Regulations 3
J MDD to MDR transition - Time required for the implementation of the MDR EU Medical Device Regulations 7
S MDR consultants - in search of recommendations for a consultant for MDR transition. Paid Consulting, Training and Services 7
K Annex XVI Device Transition Timeline under the MDR EU Medical Device Regulations 2
B ISO 9001:2015 Transition: Much Easier Than You Think! Misc. Quality Assurance and Business Systems Related Topics 0
M UDI transition period and implementation EU Medical Device Regulations 6
M Informational The US FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication Medical Device and FDA Regulations and Standards News 0
O New MDR 2017/745 Transition Strategy - 2019 Manufacturing and Related Processes 3
A How to manage the QMS system and SOP during the transition from MDD to MDR EU Medical Device Regulations 4
S When is the last date for transition to ISO/IEC 80079-34:2018? Other ISO and International Standards and European Regulations 0
K CE mark transition and new regulations CE Marking (Conformité Européene) / CB Scheme 0
Ronen E Informational ISO 13485:2016 Transition Period End - 1 March 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
T MDR Guidance Book - Useful for MDR transition? EU Medical Device Regulations 1
M Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices Medical Device and FDA Regulations and Standards News 13
H Transition to ISO 13485:2016 together with ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 12
Ed Panek Transition to IEC 60601 4th Edition - Risk Analysis and test submissions CE Marking (Conformité Européene) / CB Scheme 2
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
M Medical Device News FDA News - 26-09-18 - FDA Reveals Vision for the Transition to ISO 13485 Other US Medical Device Regulations 1
M MDSAP Transition - Health Canada Website Notice on Apr 13 2018 Canada Medical Device Regulations 1
O IEC 60601-1-2 4th edition transition deadline Dec 31 2018 CE Marking (Conformité Européene) / CB Scheme 1
qualprod Transition and recertification at the same time? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P How To Transition From AS9100c to AS9100 Rev. D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
A ISO 14001:2015 transition from the 2004 standard ISO 14001:2015 Specific Discussions 8
F IATF 16949:2016 transition audit - Internal Audit Closures IATF 16949 - Automotive Quality Systems Standard 13
W AS9120A to AS9120B transition AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
L Transition date to IEC 60601-1-11:2015 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Q Surveillance Audit of 2008 before Transition Audit to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
B Going into IATF 16949 transition without Internal Audits IATF 16949 - Automotive Quality Systems Standard 4
pammesue We have done NOTHING toward the ISO 9001 transition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
S Management representative transition checklist IEC 27001 - Information Security Management Systems (ISMS) 7
O ISO 9001:2015 Transition Internal Audit completion thread ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
A ISO 14001:2015 transition audit - Major NC due to the procedure and audit plan ISO 14001:2015 Specific Discussions 10
T ISO 9001:2008 to 2015 transition - How much work to change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
G Upkeep of ISO 9001:2008 during Transition TO ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D AS9110 Re-Certification & Transition Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Is there enough time left to transition to ISO 13485:2016 and MDSAP? ISO 13485:2016 - Medical Device Quality Management Systems 1
M AS9100 Rev. D Transition Audit - Number of Audit Days AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
G Effect of ISO9001 2015 transition on ISO IEC 80079-34 Other ISO and International Standards and European Regulations 2
R Who here is Using a Consultant for ISO 9001 Transition? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Sidney Vianna One year to ISO 9001 and 14001 transition deadline. ISO & IAF communique' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Sidney Vianna IATF bringing stakeholders together to ensure Transition by the 2018-09-14 deadline IATF 16949 - Automotive Quality Systems Standard 10
D Number of Audit Days - AS9100D Transition for a Small Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Ronen E Transition to MDR (EU 2017/745) - I'd like to make an offer EU Medical Device Regulations 12
Q Presentation for Employees - Starting the ISO 9001:2015 Transition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K AS9100 Rev. D Transition - Internal Audits & Gap Analysis Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
M Who has had a Transition Audit from TS 16949 to IATF 16949 IATF 16949 - Automotive Quality Systems Standard 120
S Question for those who have completed Transition Audit for ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7

Similar threads

Top Bottom