Someone Retires - Who assumes responsibility for documents that person approved?

D

dbulak

#1
Some one retires

According to the old ISO standard and new ISO standard,

Question 1
A person retires. A new person takes his place. Do all the old documents (procedures) the retired person signed have to be resigned by the new person? with a new revision level?

Question 2
If we now start printing a form that now has "approved by," and "date approved" printed on it,, do we have to change the revision level of the form? we generate the form off a pc and it was suggested that this information be printed on it.

Comments are welcome.
 
Elsmar Forum Sponsor
M

M Greenaway

#2
I have often thought it would be a great idea to get new managers to sign up to the procedures by actually reviewing and approving them when they take over - never seen it done though !
 

Mike S.

Happy to be Alive
Trusted Information Resource
#3
dbulak,

1. My opinion is no, unless your documentation control procedures say otherwise. My procedures say that documents are approved by a person who represents a function, position, or title (i.e. QA Manager, Sales Manager, Vice-President, etc.) so if Joe Smith is the Sales Manager who approved a document/procedure/WI, etc. and he retires, quits, is fired, etc. the document is still valid even though Ed Jones takes over as Sales Manager. This lets me avoid having to revise docs. every time someone changes positions.

2. I think it depends. What does your doc. control procedures say? I do not rev. control forms unless they act as, or are a part of, work instructions. If the form is simply a place to record data in a consistent way, I do not rev. control it. If the form gives instructions, and therefore failing to control it could affect the product, then I rev. control it.

Hope this makes sense -- if not write back.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#4
M Greenaway said:

I have often thought it would be a great idea to get new managers to sign up to the procedures by actually reviewing and approving them when they take over - never seen it done though !
Martin,

I understand where you are coming from, but I handle that by telling the newbie which procedures are/were authorized by his function and which he is therefore directly responsible for and suggest he review them and tell me if he sees any need for a change. If he/she sees no problems no further paperwork is required. If they are in that position they need to show some responsibility. I also tell them which procedures he or his people are responsible for following, so he can get up-to-speed. Seems easier and less hassle than requiring a re-sign. JMO.
 
J

Jimmy Olson

#5
I would agree with Mike and say that there is no need to have documents resigned if they aren't changing. We have plenty of procedures here that have been in place for quite some time and have seen a number of people come and go. New people review the procedures that are relvant to them to familiarize themselves with our process. It would be a waste of time to have a process to resign something when they aren't really going to fully understand everything on day one. Why have someone sign something when they get here when they might change the procdure a few months down the road after they understand everything?

As far as the second question, I don't see a problem, as long as you allow it. Our procedure specifically allows us to make minor changes without reving the document as long as it doesn't change the function (such as typos, grammatical stuff, etc.). I think this particular situation would depend on the form and any relevant instructions or procedures. If it is simply a line for approval within the company, it doesn't change the form itself.

I would review your documentation procedures though if you do this. If you are going to be signing approval on the form instead of, or in addition to somewhere else, then you will need to update your approval procedure in some way.
 

SteelMaiden

Super Moderator
Super Moderator
#6
I gotta go with Mike and Richard here. A new manager probably does not have the knowledge needed coming into the job to make a good call on re-approving a document. Tell him to look them over as he gets his feet wet and make revs as he changes process.

As for approval names on forms, it does kind of depend on what your system says....that being said, IMHO, I don't like putting anybody's name on forms, job titles, OK, but names may come and names may go, so to speak.

Have a good one!
 
L

Lyn N Iles

#8
May I suggest that if the person who retires happens to be the head honcho of the company or division, then the new incumbent should sign the overarching quality policy document as a demonstration of top management commitment.

Whether anybody agrees with me or not - hooray! My first post, although I scan the site regularly.

Lots of good stuff here.
 

CarolX

Super Moderator
Super Moderator
#9
Okay Folks, I need your opinions here....

I posted here becuase this situation is along a similar line...but with a sad twist.

In February, the owner of the company I work for passed away. Now, the only document he had to approve was the policy manual, which hasn't changed since it's original release in 2000. All other management reviews/approvals/etc. were done by myself and the VP. Now the VP is president and majority share holder. Does anyone see a problem with leaving this as is until I go for the 9K2K upgrade later this year.

Let me add a little more info. The owner and VP were also best friends. I was in no way confortable asking him to re-sign the cover page to replace the owners name.

Thoughts?

And thanks,

CarolX
 

Randy

Super Moderator
#10
This can potentially be dangerous ground. In the crowd I deal with we have the term tossed about "knew or should have known". A judge won't buy off on "I wasn't familiar with the procedure". If you have a position of responsibility you should know what you are responsible for.

When a new commander takes over a unit he/she must re-sign all standing orders for the organization. This accomplishes a couple of things, some of which are.

1.The new commander becomes familiar with what is expected and required.
2. Unit pesonnel become aware that the commander is familiar with requirements.
3. By signing the commander takes ownership and acknowledges responsibility.

In my civilian worklife I have applied the same mindset. If I'm going to be responsible and held accountable I want to know and let others know that I know also.
 
Thread starter Similar threads Forum Replies Date
M Can someone share a scrubbed version of Clinical Evaluation Plan (CEP) EU Medical Device Regulations 2
I "On the job training" as a response to how someone was trained? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 75
I Root Cause Analysis when someone simply stops performing a task? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
T Misbranding (by someone we've contracted with) in a Publication 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
Q QI Macro Histogram - Can someone define *sorted data*? Capability, Accuracy and Stability - Processes, Machines, etc. 7
J Can someone help me get the UCL AND LCL for this problem? Statistical Analysis Tools, Techniques and SPC 2
A Can someone provide an example of a Product Safety Policy? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
L To share or not to share? Work distribution when someone goes on vacation Quality Manager and Management Related Issues 19
B What is the implication for someone who does not meet the 70% pass mark for QMS-Lead. Professional Certifications and Degrees 2
B Any future for someone working as Lead Quality right these days? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Can someone share example of FAI Inspection Plan ? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
L Does someone has experience with a Supplier "Quality Watch" Supplier Quality Assurance and other Supplier Issues 3
R Full Time Internal Auditor - Where should I be looking for someone? Career and Occupation Discussions 15
P Can someone share their experience with KFDA Inspection ? Other Medical Device Regulations World-Wide 30
M Medical Device Regulation in Mongolia - Can someone help? Other Medical Device and Orthopedic Related Topics 3
R Someone can help me with the Volkswagen LiOn and BeON-QPN System? Customer and Company Specific Requirements 3
S Do Work Instructions need to be approved by someone other than the author? Document Control Systems, Procedures, Forms and Templates 14
E Can someone help me with ISO 11539:1999 for contact lens classification? Other US Medical Device Regulations 2
Jim Wynne Someone better "diffuse" me before I asplode Coffee Break and Water Cooler Discussions 7
B Does someone use APQP for non automotive industrie? IATF 16949 - Automotive Quality Systems Standard 2
D En 62366:2006 - Can someone explain what EN 62366:2006 covers? Other ISO and International Standards and European Regulations 3
G I hope someone can give me a hand.. Various Other Specifications, Standards, and related Requirements 4
1 Career Advice - What someone with my qualifications can shoot for Career and Occupation Discussions 7
S Seek advice from someone that passed through NADCAP AC7102 and AC7101/3 Various Other Specifications, Standards, and related Requirements 6
M Total Variation Formula - Can someone provide a source for this formula Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
Q COQ (Cost of Quality) - Would someone review this doc and offer feedback? Benchmarking 10
K Internal Audit Guidelines for someone new Internal Auditing 12
Q Can someone share an Excel spreadsheet to measure Cpk or Cp values. Excel .xls Spreadsheet Templates and Tools 15
P Device marketed by someone else & different name...is a 510(k) required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
J Can I get someone to help critique this manual? Quality Management System (QMS) Manuals 19
S Could someone tell me what are the results of a Gage R&R & how to interpret it? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
F Can someone to help to compare APQP and DMAIC? Six Sigma 10
C SPC presentation - How to convince someone to use SPC - Grind diameters Statistical Analysis Tools, Techniques and SPC 6
D Can Someone help me to understand....... Imported Legacy Blogs 3
Q REACH - Is it not the same as RoHS /IMDS? Can someone explain? RoHS, REACH, ELV, IMDS and Restricted Substances 1
J Sine Plate Charts - Someone lost the angle chart - Where can I get one? General Measurement Device and Calibration Topics 4
D Can someone take a look at my QM (Quality Manual)? Quality Management System (QMS) Manuals 7
C Can someone clarify "Resolution", "Discrimination" and "ndc"? General Measurement Device and Calibration Topics 4
A Internal Auditor - What is required to have someone qualified as an internal auditor? Other Medical Device and Orthopedic Related Topics 35
M Inspector Qualifications - Qualifying someone to be an inspector Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
ScottK Can someone clarify the Trans Fat thing? i.e. What = Bad Coffee Break and Water Cooler Discussions 8
GStough Looking for someone with experience in MDD, PPE, CMDR/CMDCAS regs General Auditing Discussions 1
H What I am trying to find is someone that remembers Memphis in the nineties Coffee Break and Water Cooler Discussions 10
ScottK Can someone explain the marketing behind this ad? Coffee Break and Water Cooler Discussions 21
M Escalation methods - Having to go over someone's head to address an issue Nonconformance and Corrective Action 6
E Synchronicity - Has someone lived an Event of Synchronicity? Coffee Break and Water Cooler Discussions 4
sardonyx DMR Index - Can someone share their Device Master Record Index structure or format? ISO 13485:2016 - Medical Device Quality Management Systems 15
M Internal Auditing Independence Rule - Can someone provide a good interpretation Internal Auditing 20
samer How can someone create his own acceptance criteria ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Y Want to meet someone from big 3 in the supplier develop field to learn from Supplier Quality Assurance and other Supplier Issues 6

Similar threads

Top Bottom