How do you structure your QA (QMS) Manual? A Historical Discussion

E Wall

Just Me!
Super Moderator
#41
You don't know how glad I am to hear that!

Glad it wasn't my imaganings! :p
I most always get the edit note...if I haven't I don't realize it. But then I'm always getting interupted when at my desk...not to mention long winded :) so I guess I'm exceeding the 'grace' period.

Well I have some changes to get finished to my RCA program...sometimes I feel like I'm writing for 5th graders the way EVERYTHING needs to be spelled out...but anything open to interpretation seems to be challenged, so I'm updating the process...again!

hhehee, chicken hawk...I like that, I'll have to search through the avatars...wasnt' there a chicken-hawk on the Foghorn Leghorn cartoons?
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#42
I think when you go in and edit a post you've been 'working on' within the allotted time period, the timer resets for another 15 minutes or whatever time is set in the admin options when you submit the edited version.

Yup - Foghorn Leghorn (the rooster) is always being 'bothered' by the little chicken hawk.

But - back to Quality Manual issues!
 
V

venkat

#43
Editing text

At times two persons can convey the same issues. One cant generalise that it was copied from the other.

If edit option is available after post this is possible.

I dont think this is an issue.

Let's discuss about quality, quality, quality - it can be applicable to any type of organisation.

I see very few post pertaining to US FDA approvals. What type of documentation one should prepare if a pharmaceutical company go in for US FDA approvals. The sequence of sgteps involved

Your views please
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#44
Re: Editing text

Originally posted by venkat

I see very few post pertaining to US FDA approvals. What type of documentation one should prepare if a pharmaceutical company go in for US FDA approvals. The sequence of sgteps involved

Your views please
Well, there is an FDA related forum where you might want to start a new thread on this topic. That forums is at: http://Elsmar.com/Forums/forumdisplay.php?forumid=44

You'll have to go back at least 100 days to see any posts. The forum isn't very active.
 
T

tim banic

#45
my 2 cents worth...

Actually that would be Canadian pennies so I should really put 4 in for the exchange.

I was chatting with our registrar earlier in the week about changing our manual over to 9000:2000.

What he told me was (& I am not sure if anyone else has said this already)...look at our process, from start to finish & create main headings (Selling the product/service, then what is the next step, then the next step, forward to design/engineering, forward design to the shop floor, etc, etc, etc)

Each of these main headings is a procedure, and each step to that main heading is a point to be detailed in that procedure (be it in the procedure or reference to work instructions).

When these are complete compare it to the requirements of the standard. If you are missing any information from the standard plug it in where it belongs.

Anything that doesn't fit into one of the main heading for your business process gets placed under Management Responsibility (including Internal audits, Management Review meetings, etc.).

What the auditor told me was that "Yes it makes them work a little harder to find the information (but in MHO that is what they are being paid for), but it follows the way product/service flows through the company.

I hope this makes sense to everyone...if anyone would like to email me to discuss this more, please do (our email is hit & miss sometimes, but I will respond ASAP). I am figuring that this will take me about 1 - 2 weeks to complete (walking through the process, discussing ith staff & departments & writing the procedures).

I Would love to hear everyones opinion.

thanks tim

"...if it moves, train it...if it doesn't move, calibrate it...if it isn't written down, it never happened..."
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#46
If it works for you, do it that way. I see no problem with that methodology except how much time you want to put into it.
 
G

Greg B

#48
This is a Classic

Carl said:
DuDu,

The easiest way I have found (I have done this 4 times) is to copy sections 1 through 8.5 of the standard, VERBATIM, then use the edit/replace function to replace all references to "the organization" with your company name. You will not be able to cut and paste from the electronic version of the standard, so someone will need to manually type the manual. After you are done this go through each section and wordsmith to fit your organization. Be careful when deleting anything. This makes it virtually impossible for a registrar to give a nonconformance for the manual not fitting the standard. Let's face it, the only reason you are writing the manual in the first place is to pass your audit and possibly send to a customer. It serves no real purpose, so make it easy on yourself. The last manual I wrote took a total of 4 hours for someone to type and about another 4 of my editing.

Good luck,

Carl-
:eek:
This is from waaaay back ( 12th July 2001) but when I read it I had to bring it to the attention of the current audience. If everyone did as Carl has suggested above why would we need a quality manual??? Couldn't the registrar or customer change our name to fit the 'organisation' in the standard therfore relieving us of the need to write a manual (just to waste paper)??? I have had manuals that were ....almost...verbatim from the standard but nothing like Carl's description. My new manual - in development (again) will be a story of our company, products and methodology for our customers and employees. All of our new employees and customers will recieve a copy. I hope to finish the manual in the next few weeks. It will have many process and flow charts . I was going to have only charts but decided that it needed a little more explanation.

Greg B
 
Last edited by a moderator:

Marc

Hunkered Down for the Duration
Staff member
Admin
#49
That was just the way you had to do it back a while in large part to satisfy auditors.

Things have seriously changed, eh?
 

Paul Simpson

Trusted Information Resource
#50
Phew that was close!

I almost had my sanctimonious hat on! I saw the thread on "Definitive discussion on QM" come up and started reading some of the drivel about turning the standard on its head and thought it was current! Thank goodness nobody on the cove is encouraging that any more.
 
Last edited:
Thread starter Similar threads Forum Replies Date
rvin59 OHSAS 18001 - QMS - EMS Combined Manual Structure help Occupational Health & Safety Management Standards 5
P Japan MHLW Ordinance No 94. (QMS structure Regulation) Japan Medical Device Regulations 1
D Divisions delay QMS Certification due to un-modified Organization Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
O QMS (Quality Management Systems) Team Structure & Responsibilities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
D Quality Team Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
M How to complete structure Analysis and Function analysis sections' columns of AIAG-VDA DFMEA form FMEA and Control Plans 0
U IT Process is Taken From company and Added to Corporate Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Informational IMDRF proposed document – IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) – Anne Medical Device and FDA Regulations and Standards News 0
D China - Where I can get NMPA complete structure/organogram chart and GB/YY format list China Medical Device Regulations 1
S MDR Technical File Structure Requirements EU Medical Device Regulations 12
M FMEA/DCP Structure and Quantity - Similar Parts and Processes FMEA and Control Plans 7
E Department Plan for QA and HSE (profile, plans, structure, goals, etc.) Misc. Quality Assurance and Business Systems Related Topics 2
R How to create a Work Breakdown Structure? Registrars and Notified Bodies 2
F Business expanding - Campus vs Multi Site Certification Structure AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
D Technical file structure/content requirements for Class IIa devices & new MDR EU Medical Device Regulations 14
Paul Simpson Informational The role of Annex SL - High Level Structure of ISO MSS's - Revision Update February 2019 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
E High level structure - Planning and operation control Occupational Health & Safety Management Standards 2
S Has anyone created a Turtle Diagram reflecting the new ISO 9001:2015 Structure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M ISO 13485 and the High Level Structure (HLS) ISO 13485:2016 - Medical Device Quality Management Systems 0
P Is the next revision of ISO 15378 following the High Level Structure? Other ISO and International Standards and European Regulations 5
M Kinds of plastic for molded parts in a main frame as structure Manufacturing and Related Processes 7
M Organizational Chart - Organizational Structure example wanted Quality Manager and Management Related Issues 2
P Do I need to Register with FDA? How shall my structure of processes look like? US Food and Drug Administration (FDA) 4
F Quality Manager - Conflict of interests in organisational structure AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
S How to Add Water to a MDS Tree Structure RoHS, REACH, ELV, IMDS and Restricted Substances 4
J Setup/structure of IDE in the US Other US Medical Device Regulations 3
R ISO 14001 - EH&S Reporting Structure & Products and Process ISO 14001:2015 Specific Discussions 2
T Quality Department Structure in a Small Medical Device Company Quality Manager and Management Related Issues 4
E Is GHTF Classification Structure similar to EU MDD Calssification EU Medical Device Regulations 3
M ISO 9001 Work Instruction Structure Document Control Systems, Procedures, Forms and Templates 1
M Please help to change the numbering in level 3 of structure Document Control Systems, Procedures, Forms and Templates 1
T Information and Structure for Technical Documentation for Firmware ISO 13485:2016 - Medical Device Quality Management Systems 1
D Internal Audit Structure and Focus Internal Auditing 7
Marc ISO 9001:2015 Structure - Top Level Clauses ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
insect warfare How is the Management Review structure of your company set up? Management Review Meetings and related Processes 5
J How to structure a DHF when all manufacturing is done by Contract Maufacturers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
JodiB Structure and Content of Job Descriptions General Measurement Device and Calibration Topics 2
A Organisation Structure and Responsibilities - Clarification Misc. Quality Assurance and Business Systems Related Topics 6
G Structure and Method behind the Planning of 8.2.2 Internal Audit Internal Auditing 6
B Controlled document training requirements and structure ISO 13485:2016 - Medical Device Quality Management Systems 2
S Company Structure for OHSAS Certification - Holding Company with Subsidaries Occupational Health & Safety Management Standards 5
Q Minimum Organization Structure to support TS16949 IATF 16949 - Automotive Quality Systems Standard 5
D New Structure for ISO-14001 and other Management System Standards ISO 14001:2015 Specific Discussions 7
R Registering Medical Device in Brazil ANVISA - Fee Structure Other Medical Device Regulations World-Wide 1
AmandaMusser Documentation Confusion - Agile BOM Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J QA Organizational Reporting Structure for a sample Food Operation Food Safety - ISO 22000, HACCP (21 CFR 120) 4
V Corporate Quality Management System - Structure, Pros and Cons? Quality Manager and Management Related Issues 3
P Please critique my Organization Structure Chart ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Company Safety Culture Assessment - How should I structure the Surveys & Interviews? Human Factors and Ergonomics in Engineering 7
Similar threads


















































Top Bottom