Author and Reviewer - Can they be the same person?

C

Catrina

#1
Author and Reviewer

Help me to put an end to an argument I am having with a co-worker in regards to documentation.

A person cannot author(write) a document and be an editor (reviewer) of the document at the same time? Doesn't this defeat the purpose? I believe the author can be a validator to the written procedure, WI, etc., but they cannot be listed as a reviewer of the document.

Opinions?

Thanks
:bonk:
 
Elsmar Forum Sponsor
A

Al Dyer

#2
I don't see any problem with an author reviewing their own work. The important part is the approval process in which all departments that have input or are affected by the document need to approve the document.

At a time when I was the internal auditor I reviewed and approved all of my own documents other than the Level II procedure. With that one I had the General Manager as the second approval.
 

SteelMaiden

Super Moderator
Trusted Information Resource
#3
Gotta agree that an author can review documents. Number one, usually (at least here) the person writing the document is the one that knows how it's done. Number two, we have at least two people approving documents, typically one of supervisory or above level, and the second is myself for compliance issues. So, in the case of a work instruction, they would be written either by an hourly person, or one of our salaried "technical staff". The approval process would be the area supervisor (who may or may not be on the tech staff) and myself (I am a tech staff member and supervisor).

If your people are hired, grandfathered, or trained to assess documentation and their performance shows they can carry out the function in an unbiased and effective way, there should be no problem at all.
 

E Wall

Just Me!
Trusted Information Resource
#4
What we have in place is that all staff who are involved (auditors/supervisors/engineers/managers/etc...) in the process are included in reviewing a document when a change is proposed. All Document Change Requests (includes initiating new documents or making any obsolete) must be approved by the QA and Plant Managers and ISO Coordinator.

We have a designated 'reviewer' identified for all documents (require periodic review based on last revision date) and our rule of thumb there is whomever the manager is over that process is the reviewer (regardless of who the last editor of a document was).

Confusing enough? :ko: I'm going a bit loopy today.

TGIF! Eileen
 
Thread starter Similar threads Forum Replies Date
S Is the document author required to be identified as part of Document Change Notice? ISO 13485:2016 - Medical Device Quality Management Systems 5
drgnrider Job descriptions (4.4.1): Management Rep, Document Author, Document Approver Miscellaneous Environmental Standards and EMS Related Discussions 13
Marc Thomas Jefferson, co-author of the United States Declaration of Independence Coffee Break and Water Cooler Discussions 1
S Do Work Instructions need to be approved by someone other than the author? Document Control Systems, Procedures, Forms and Templates 14
J Revising a management manual, who should be the author? Document Control Systems, Procedures, Forms and Templates 4
P Document Layout - Different layouts for documents depending upon the author Document Control Systems, Procedures, Forms and Templates 7
P Is the author of ?How to Become a Billionaire?? really wealthy? Coffee Break and Water Cooler Discussions 6
B Defining Responsibilities - Author and Owner Policies Document Control Systems, Procedures, Forms and Templates 12
B Who is the author of your procedures and work instructions? Document Control Systems, Procedures, Forms and Templates 13
Marc Jef Raskin dies at 61 - Macintosh Pioneer - Author of The Humane Interface After Work and Weekend Discussion Topics 0
Marc Charles Sheffield Dies - Physicist, Sci-Fi Author Book, Video, Blog and Web Site Reviews and Recommendations 0
briteme4 AS9102 First Article Inspection - do I need a second reviewer and signer? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P Choice of FDA reviewer US Food and Drug Administration (FDA) 6
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
lilybef FDA and Biocompatability Testing - Reviewer has requested implantation testing Other Medical Device Related Standards 11
C Mexico Medical Device Third Party Reviewer Other Medical Device Regulations World-Wide 2
S What is the role of "Reviewer" and "Approver" in the preparation of procedures? Document Control Systems, Procedures, Forms and Templates 9
A Performer, Verifier, Reviewer & Approver Signatures on a Quality Record US Food and Drug Administration (FDA) 3
N Can we use Third-party 510(k) reviewer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Selling same device as IVD and RUO US Medical Device Regulations 8
R Selling same device as IVD and RUO EU Medical Device Regulations 1
A 510(k) and DeNovo on same medical device for different indications? US Medical Device Regulations 5
A Production for same product at two production sites AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
H EMC & Safety Testing of the product with the same Sr. No. for EC Declaration CE Marking (Conformité Européene) / CB Scheme 3
E Importer - same legal entity EU Medical Device Regulations 3
D Multiple amendments at same license Canada Medical Device Regulations 1
M Review of work - independent review? or can it be the same person ? ISO 17025 related Discussions 1
P Can credentials (ID/PW) used to login be the same as when applying Electronic Signature (Part 11) US Food and Drug Administration (FDA) 2
J Not able to repeat measurement at the same location General Measurement Device and Calibration Topics 7
V Product naming: Same name - different perfume & status CE Marking (Conformité Européene) / CB Scheme 0
Z Why Control Limits are not the same depending on type of exclusion of data points Using Minitab Software 7
K UDI for two units with different S/N on the same package/case Other US Medical Device Regulations 10
T CE Marking - Bench mark Device from same manufacturer CE Marking (Conformité Européene) / CB Scheme 2
P Arena simulation, How can my Arena model have exactly the same output each time I run it? Process Maps, Process Mapping and Turtle Diagrams 0
M Are you allowed to reuse the same asset number if the device was replaced? General Measurement Device and Calibration Topics 10
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3
Scanton Double Major for the same infraction? IATF 16949 - Automotive Quality Systems Standard 11
G Same parts but new customer - What will the auditor ask me? IATF 16949 - Automotive Quality Systems Standard 2
K 510K new manufacturer but same components Other US Medical Device Regulations 6
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Unit of Use DI (Device Identifier) - Products using the same device US Food and Drug Administration (FDA) 0
G Same intended use devices - Technical file EU Medical Device Regulations 5
K More than one importer for the same device EU Medical Device Regulations 3
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Validation of new machine (second machine of the same type) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
M MSDS process audit - Can any one give idea for checklist of the same Occupational Health & Safety Management Standards 14
L PMA and Non-PMA parts in same finished goods area? Federal Aviation Administration (FAA) Standards and Requirements 1
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1

Similar threads

Top Bottom