SBS - The best value in QMS software

Re-approving documents when the responsible person leaves or changes responsibilities

Q

QEC1989

#11
Re: Re-approving documents when the responsible person leaves or changes responsibili

Something else you may want to consider....

Have a controlled document that lists 'signature designees'.

Meaning, people that may sign in place of the person specified.
DO NOT list by the person's name, but by job title/position.

In my particular case, we list those who are lateral or downward from the signer on the organization chart, who are authorized to sign for that person.
We also explain that persons upward on the organization chart have explicit signature authority.

This may not work well for some...but for us it has been accepted and successful.
As always, your results may vary...as they say.
 
Elsmar Forum Sponsor
R

ralphsulser

#12
Re: Re-approving documents when the responsible person leaves or changes responsibili

About 3 years ago we had someone come in here at a management from one of our foreign facilities. He wanted me to go back through all the documents approved by the previous manager, and replace with his name. i got him to agree to d it whenever a document of that type was revised or updated.
Then he made me bring them to him so he could personally sign his name on the document. Fortunately he went back home at the end of 2008.:)
 
Last edited by a moderator:

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#13
Re: Re-approving documents when the responsible person leaves or changes responsibili

Please provide your input to the following question dealing with document control QMS ISO 9001:2000

Should documents that were approved with the name of an authorized person that left the company be re-approved with a new manager's name?
Kind of makes it sound like the reason the last person left was because he was an idiot, and his work could not be trusted. I doubt that was the intent of the standard. What the standard wanted to ensure was that the person responsible (and, one might easily assume "at the time"), was aware of the change and agreed to it.

Period. Controlled. Thank you...and good day. :cool:

Now, in the training section, one might want to see if the new authorized person was aware of the procedures they are responsible for. That might be fair game.... :tg:
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#14
Re: Re-approving documents when the responsible person leaves or changes responsibili

Something else you may want to consider....

Have a controlled document that lists 'signature designees'.

Meaning, people that may sign in place of the person specified.
DO NOT list by the person's name, but by job title/position.
YES!!! :agree1:

I have always done that - in fact for small companies I used "generic positions", such as Production Leader. Today, that person might be the VP of Operations....tomorrow, Production Manager. All I had to do was maintain a cross-reference, as the responsibilities of the of the employees shifted...as in "wearing many hats"...:cool:
 
M

MIREGMGR

#15
Re: Re-approving documents when the responsible person leaves or changes responsibili

As a side point, my perspective is that any approval system--"agency" based or otherwise--requires a dated, verifiable chain of records as to who had what approval authority at what time, and by what grantor-action that authority was granted.

Without such a chain of records, it can become very difficult several years after the fact to prove that Person X did in fact have duly granted authority to approve something.
 
Thread starter Similar threads Forum Replies Date
R Question of Approving Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T Approving documents prior to issue - What guarantees their adequacy? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Approving AWS as a supplier (ISO 13485) ISO 13485:2016 - Medical Device Quality Management Systems 4
M Suitable form or questionnaire for approving consultants Document Control Systems, Procedures, Forms and Templates 9
N Understanding, Challenging & Approving Supplier Control Plans FMEA and Control Plans 7
JoCam Approving a Test House on a Medical Device as a part of a 510k Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Q Approving Software Suppliers in an AS9100 Company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R Approving a New Hand Assembly Line at a Supplier Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Approving Suppliers by "Grandfathering" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
N Role of Quality Function in Approving Work Instructions Document Control Systems, Procedures, Forms and Templates 4
Q AS9100 Clause 8.3 - Control of Nonconforming Product Process for Approving Personnel AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T Approving Consulting Firms in a Medical Device Company ISO 13485:2016 - Medical Device Quality Management Systems 25
T Approving Suppliers - Approving Marketing Companies Other ISO and International Standards and European Regulations 10
P Originating and Approving Internal Procedures Document Control Systems, Procedures, Forms and Templates 9
L Approving myself as a Supplier - Should we be on our own ASL AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
M Gage R&R for Big Parts - Approving a Variable Gage using only 1 Part Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
G Does AS9100 require approving your Customer as a Supplier? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Qualifying and Approving Equipment for Welding AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Process for Approving Personnel Making Decisions - AS9100 Clause 8.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
B Approving Suppliers - Consultants AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J Approving Suppliers under 7.4.1 - Approved Suppliers List - ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Approving Suppliers under 7.4.1 - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
Anerol C Who is Approving your Manufacturing Visual Aids / Process Sheets? Document Control Systems, Procedures, Forms and Templates 6
M SOPs - Reference Documents Section Document Control Systems, Procedures, Forms and Templates 3
Dazza 9001, 14001 and 45001 mandatory documents and records cross reference matrix Process Maps, Process Mapping and Turtle Diagrams 2
M Documents to be included in 1.3 Material check in PPA report APQP and PPAP 4
J Requirement for Retention of Records of Withdrawn Documents of External Origin Document Control Systems, Procedures, Forms and Templates 3
T Sharing SharePoint Documents Document Control Systems, Procedures, Forms and Templates 4
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
M Retention period of documents and records ISO 13485:2016 - Medical Device Quality Management Systems 1
D Offsite storage of QMS documents ISO 13485:2016 - Medical Device Quality Management Systems 9
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
was named killer AS 9100D - Calibration Instructions - Controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 24
J Controlled information versus defined documents / records ISO 13485:2016 - Medical Device Quality Management Systems 3
D DQ documents of new equipment - Function specification Qualification and Validation (including 21 CFR Part 11) 0
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
qualprod To set frequency to review documents in ISO 9001 7.5? Document Control Systems, Procedures, Forms and Templates 13
S Mandatory documents vs shall "something" but without mandatory documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
I Reissuing documents due to missing version / issue numbers Document Control Systems, Procedures, Forms and Templates 3
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
M Advertising medical devices in the U.S - Advertising regulations or guidance documents Other US Medical Device Regulations 3
R Process control documents - Context of API Spec Q1, Clause 5.7.1.3 Other ISO and International Standards and European Regulations 0
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
M EU MDR - Annex II 3b - What documents fall under this requirement? EU Medical Device Regulations 3

Similar threads

Top Bottom