Paper Quality Manual Change Control Methods

T

toto2010

#1
#1
Hi Everyone,

My quality manual consists of 7 chapters with the first chapter as introduction. Altogether, it consists of 70 pages and now it is the first revision (REV 01). Every page has a header with the document name, document revision number, document effective date. If there is a page to be revised, I have to change the revision number and reprint 70 pages.

Is there a way to control so that if I change a single page of the quality manual, I just need to print a page?

Thank you for any advice.

Regards,
Toto2010
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Marc

Marc

Fully vaccinated are you?
Leader
#2
#2
You're not going to want to hear this, but jump the shark and go electronic. How small is your company? Does it have the main employees connected on a network?

NOTE: Beware of "flack" from some folks here as many people will recommend (as would I) reducing the size of your quality manual (especially since it's paper), such as by breaking it down into individual components.
 
D

deanbell

#3
#3
Agree with Marc here. If there is an ability to distribute this document electronically within your organisation, this is the best way to go. This wouldn't prevent hard copies of these documents from being used, though in this case I'd have a disclaimer inserted into the document stating "Hard copies of this document are uncontrolled". As long as you can demonstrate that your staff are only using the latest revision of the document in carrying out their duties (as per your Document Register) you will be fine.

A 70-page quality manual sounds quite large. Does your quality manual also include all of your operating procedures? If so, I would suggest separating these procedures into separate documents. This may reduce

As a note, I have developed a 34-page integrated HSEQ management system manual for my employer (incorporating the needs of 5 companies in our group), with supporting manuals and procedures to supplement this document.

Good luck :bigwave:
 
H

harry

Trusted Information Resource
#4
#4
IMHO, the standard is purposely silent on these kind of details with the purpose of giving the user flexibility and creativity to define what they want to do.

Why can't you allow or have page revision instead? It is up to you to set-up your system in a logical manner and then define them in the appropriate procedure.
 
T

Taliesyn

#5
#5
I agree with Harry. you can go whichever way you want. If you use the "Amendments" page to define what has changed and include the page number, you only need to change that 1 page . BUT, if you put the thing on your internal network as a pdf file, you can do exactly that without the hassles of changing just that one page in however many copies there are. Whatever you do, have fun!
 
T

toto2010

#6
#6
Hi Deanbell,

Thank you very much. My quality manual does not contain the procedures details but rather it points or refers to all the procedures.

Your advice including most of them are very good. Yes, I think I shall follow what you said and include change for every page.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Manix Photocopied Paper Manual - Just a Bit of a whinge about our Quality Manual Quality Management System (QMS) Manuals 14
P Moving from a Paper based Quality System to an Electronic Quality System Manufacturing and Related Processes 14
Antonio Vieira Do you still keep old numbers of Quality Progress in paper format? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 9
T Incoming (Receiving) Quality Control Laboratory for Raw Paper Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
S Concept Paper Requirements from ISMS and Quality Perspective Misc. Quality Assurance and Business Systems Related Topics 3
S Global Quality Leader Research Paper The Reading Room 2
D Read or recite? Is it OK to read the company quality policy from a sheet of paper? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Hourly Check Sheets, Waste of paper or integral part of quality system? IATF 16949 - Automotive Quality Systems Standard 29
Marc 'Quality' Is Not Dead - A Term paper - Survival of quality (your job) Misc. Quality Assurance and Business Systems Related Topics 10
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Regulations on Controlled Document Size (Paper Size) Document Control Systems, Procedures, Forms and Templates 4
dgrainger Informational EC - Medical devices – online manuals replacing paper instructions - Feedback period: 27 April 2021 - 25 May 2021 EU Medical Device Regulations 0
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 4
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
M MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU EU Medical Device Regulations 6
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 19
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
B Do you use paper or web-based templates for CAPA processes? ISO 13485:2016 - Medical Device Quality Management Systems 3
qualprod From paper to Electronic (records) in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R ISO 45001 Lead Auditor Exam paper Training - Internal, External, Online and Distance Learning 1
M Informational US FDA paper – Epidemiological Evidence on the Adverse Health Effects Reports in Relation to Mercury from Dental Amalgam: Systematic Literature Review Medical Device and FDA Regulations and Standards News 0
M Informational US FDA paper – Biological Responses to Metal Implants Medical Device and FDA Regulations and Standards News 0
M Informational US – MITA UPDATES SERVICING AND REMANUFACTURING WHITE PAPER Medical Device and FDA Regulations and Standards News 0
M Informational FDA discussion paper – Consideration of Benefit-Risk Approaches for Weight-Loss Devices Medical Device and FDA Regulations and Standards News 0
M Informational Paper on open access – EU postmarket surveillance plans for medical devices Medical Device and FDA Regulations and Standards News 1
L Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Sidney Vianna Interesting Discussion ISO 9001 audits from the perspective of registrants' customers - an interesting paper Registrars and Notified Bodies 0
N Time source for paper-based documentation (research nurses) US Food and Drug Administration (FDA) 1
U Electronic templates for making paper control charts Reliability Analysis - Predictions, Testing and Standards 2
M Informational COCIR Position Paper Harmonisation of Standards for Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational COCIR paper – Advancing Cybersecurity Of Health And Digital Technologies Medical Device and FDA Regulations and Standards News 0
M Informational DITTA White Paper on Cybersecurity: Best Practices in the Medical Technology Manufacturing Environment Medical Device and FDA Regulations and Standards News 0
qualprod What tier number fits in a company producing paper labels stuck on automotive parts? IATF 16949 - Automotive Quality Systems Standard 7
C Karl Fischer Titrators and 21 CTR Part 11 and Paper Records Qualification and Validation (including 21 CFR Part 11) 6
M Medical Device News NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application” Medical Device and FDA Regulations and Standards News 0
S Paper-based QMS ISO 13485:2016 - Medical Device Quality Management Systems 9
M Position paper Team NB Statement - Patient safety EU Medical Device Regulations 0
G Calibration Certificate, fancy paper or not? General Measurement Device and Calibration Topics 9
T ISO 9001:2015 by Craig Cochran - ebook or paper? Coffee Break and Water Cooler Discussions 9
M Design of Experiments - Paper Helicopter Example Using Minitab Software 1
A Splitting Paper Routing Job Worksheets AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M How to Measure Paper considering Variation and Humidity General Measurement Device and Calibration Topics 10
S Migrating from paper based to electronic system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L BSI White Paper on Human Factors/Usability Engineering IEC 62366 - Medical Device Usability Engineering 12
A Preventive Action or Corrective Action - Paper cuts Nonconformance and Corrective Action 14
A Receiving paper from the customer and never knowing when it will arrive Quality Manager and Management Related Issues 1
D How to approach Paper and Electronic Record Control for ISO 9001:2008 Records and Data - Quality, Legal and Other Evidence 7
G Paper Based Manufacturing with an Unvalidated ERP ISO 13485:2016 - Medical Device Quality Management Systems 3
S 21 CFR 11 - Require paper and hand signatures not electronic Other US Medical Device Regulations 2
Q Kraft Paper / Core Paper MSDS - Plastic Specs IATF 16949 - Automotive Quality Systems Standard 4

Similar threads

Top Bottom