Defining Major vs. Minor Changes to Procedures

T

TigerLilie

#1
We define major changes to a procedure as something that alters the form, fit or, function, such as a change in process. In this case, procedures must be up rev'ed. Minor Changes, such as spelling or grammar do not require an up rev.

We have a policy embedded in a manual and when the Company changed CEOs, I changed the name on the policy to the new CEO but did not up rev because there was no material change in the process. I viewed it as a minor change.

Thoughts?
 
Elsmar Forum Sponsor

hogheavenfarm

Quite Involved in Discussions
#3
I do something similar, but the change, even if it is just a review of the procedure, is noted in the revision page, I just do not update the rev number or date. I periodically review all of the procedures and they are noted in the matrix in the front, just to make it easy for others to know "I was there".
So, yes, I sometimes do not change the rev level and date for minor changes, corrections, or even additions if it simply a clarification.
But Every access to the document is noted, even if nothing changes.
 

Mark Meer

Trusted Information Resource
#4
As far a procedure changes, because there is no particular requirement to distinguish between "major" and "minor" (or any other such categorizations), how you handle it is purely up to you.

In our system, if it's changed it's a new revision.
While there is no explicit distinction between "major" and "minor" changes, there are a bunch of decisions within the change process that define a spectrum of significance. For example does the change require training/re-training, verification and/or validation, supplier/customer/regulatory notifications...and so on. No to all = minor change.

Though I have often considered a major/minor revision level system (e.g. a minor change to "revision 1.1" would be "revision 1.2", and personnel are allowed to use any "1.x" document as the differences between them are deemed inconsequential (spelling/grammar/formatting corrections). ...but why complicate things, right?

Personally, I keep track of "minor" things such as spelling or grammar and queue them to be included in future revisions. ...no point processing changes that are not going to actually make any tangible improvements.
 

John Broomfield

Staff member
Super Moderator
#5
We define major changes to a procedure as something that alters the form, fit or, function, such as a change in process. In this case, procedures must be up rev'ed. Minor Changes, such as spelling or grammar do not require an up rev.

We have a policy embedded in a manual and when the Company changed CEOs, I changed the name on the policy to the new CEO but did not up rev because there was no material change in the process. I viewed it as a minor change.

Thoughts?
TigerLilie,

I agree with the way you have defined major and minor changes and with the way you have used this definition.

John
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#6
I also support major and minor changes, in my last employer the criteria were similar. We called these minor changes "administrative change" and made a note in the revision change block without uprev or a need for full signature loop.
 

Mark Meer

Trusted Information Resource
#7
While I appreciate how it could be of use, my reservations on implementing a major/minor change system as described are as follows:

  1. How necessary are these "minor" changes? If, for example, the spelling and grammar are so atrocious that management declares a change is necessary, then there's probably a problem at the review/approval stage. If it's just a few minor spelling mistakes that don't have any effect, it seems like it'd be simpler just to make note and include them in a future ("major") revision.
  2. The unnecessary complication of change process. Essentially, you are defining another category of change which is handled differently. While this doesn't necessarily double the complexity, it does inject a bunch of "if"s, "but"s and "unless"s into your process.
  3. The "gray" areas. For example, does the formatting change affect the legibility? Do the grammatical errors cause confusion? These are cases where the changes may appear minor, but in fact are affecting their use.

I'm sure there are ways to overcome these, and that many companies have an effective system for major/minor changes. ...but my advice would be to carefully weight the value/benefits of a major/minor change system against the potential administrative costs of implementing and maintaining it...
 
Last edited:

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#8
Administrative changes should be used with care to ensure the document's understandability is not changed. It's true they can mask or enable poor grammar, but that can be approached independently after the document gets fixed.

Sometimes I see administrative changes done to fix pagination, add revision numbers to each page, change the logo in the header if the company is acquired, correct misspellings, even to fix hyperlinks if document control software prevents checking out and in without evidence of having done so. Adding a note explaining the change in a revision block or comment in the software helps provide the traceability these processes need to stay credible.
 

hogheavenfarm

Quite Involved in Discussions
#9
Our external auditors frequently ask for these, I in the past I have gotten comments to the effect "I see this has not been updated in a few years...".
Now I log every revision, no matter how minor on the revision page, keeping the same version number and date, but adding a note explaining what was done. I have found that adding this note when I review the procedure for any reason, even without any changes at all, at least shows that it is actively being looked at at.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#10
Our external auditors frequently ask for these, I in the past I have gotten comments to the effect "I see this has not been updated in a few years...".
Now I log every revision, no matter how minor on the revision page, keeping the same version number and date, but adding a note explaining what was done. I have found that adding this note when I review the procedure for any reason, even without any changes at all, at least shows that it is actively being looked at at.
It is a good practice to log a periodic review, even if nothing changes. :agree1:
 
Thread starter Similar threads Forum Replies Date
J Internal Audit Findings - Major vs. Minor Finding - Defining the differences Internal Auditing 14
5 Major Nonconformance for not "clearly" defining the "device lifetime" ISO 13485:2016 - Medical Device Quality Management Systems 2
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
T Defining sampling plan for different AQL AQL - Acceptable Quality Level 1
M Defining frequency of measurement tools callibration Calibration and Metrology Software and Hardware 3
M Defining and Documenting Record Retention CE Marking (Conformité Européene) / CB Scheme 5
G Defining performance metrics for DFMA implementation Design and Development of Products and Processes 2
S Defining a Quality System from scratch - Preferred system and documentation names Document Control Systems, Procedures, Forms and Templates 4
A Defining Expected Service Life in Risk Management File Reliability Analysis - Predictions, Testing and Standards 5
C Defining Approvals Required for Design Control Documents ISO 13485:2016 - Medical Device Quality Management Systems 6
khotchandrakant Defining Acceptance Quality Level, I need clarity on AQL 1.5, 2.5, 4.0 AQL - Acceptable Quality Level 5
M Defining the lifetime of orthopedic implants joints Other Medical Device and Orthopedic Related Topics 2
C AS9100 rev D 8.5.1 c 2 - Defining the Machine in-process frequency per ANSI/ASQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
V Defining Safety Precautions for Category 4,5 Molecules Occupational Health & Safety Management Standards 2
E European Regulations defining the terms Repair and Refurbish EU Medical Device Regulations 5
GStough Adequately Defining Which Suppliers to Audit and Frequency Supplier Quality Assurance and other Supplier Issues 8
E Quality Techucuan (Technician) in Electronics - Defining Postion Requirements Career and Occupation Discussions 4
moritz Defining a good Scope for Critical SOPs ISO 13485:2016 - Medical Device Quality Management Systems 7
T Standards for defining audible alarms/warnings for OR instruments IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Defining Critical Vs. Non-Critical Suppliers/Service Providers (API Q1, 9th. Ed.) Oil and Gas Industry Standards and Regulations 2
B IEC 60601-2-24 - Defining Storage Volume IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Defining Sub-Disciplines for Chemical Testing Laboratory Employee Proficiency Testing General Measurement Device and Calibration Topics 1
T Defining Nonconformances in a Service Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Defining Reliability and Confidence Levels Reliability Analysis - Predictions, Testing and Standards 3
J Defining Martial Arts and Gymnastics Statistical Techniques Statistical Analysis Tools, Techniques and SPC 4
V Defining the criteria for equipment to be qualified or requalified Qualification and Validation (including 21 CFR Part 11) 2
R Need help on defining scope for Design Verification File for Class III IVD 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Defining CCP (Critical Control Points) in a Rice Mill Plant Food Safety - ISO 22000, HACCP (21 CFR 120) 9
S Process Map and defining KPIs Misc. Quality Assurance and Business Systems Related Topics 5
E Defining the lifetime of an Implantable Medical Device Other Medical Device and Orthopedic Related Topics 5
B Defining Expected Oxygen Leakage for Safety Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
G Defining Post Mold Cure Ramp-Down Temperature Manufacturing and Related Processes 2
K Audit Nonconformity on Defining 'Outsourced' Infrastructure Maintenance Quality Manager and Management Related Issues 21
G Points to consider while defining the Quality Policy AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
G Defining Quality Objectives for Product Realization and Design and Development AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Developing Documentation and Defining Processes as Subcontractor IATF 16949 - Automotive Quality Systems Standard 6
C Defining ISO 9001:2008 Scope for a Sterilization Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Defining Skilled vs. Semi-Skilled vs. Unskilled Labor Manufacturing and Related Processes 1
I Defining the scope for ISO 9001 Registration - Software, Hardware and Customer Care ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Product Specification vs. Information Defining Product - The differences? 7.3.3.1 IATF 16949 - Automotive Quality Systems Standard 6
R Defining Interaction of Processes in a Software Company Software Quality Assurance 3
N Where to begin defining and monitoring Quality Metrics in a Machine Shop Manufacturing and Related Processes 9
A Testing Process Audit - Defining a Process Compliance Mechanism Software Quality Assurance 2
R Defining the type of Applied Part - Metal Probe (Applied Part) employs Water Cooling IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Defining Security Interfaces for Scope for ISMS - Need help IEC 27001 - Information Security Management Systems (ISMS) 10
A Defining the differences between Prototype vs. Production Guidelines? Contract Review Process 5
R Help defining Eyewear Customer Complaint Categories Customer Complaints 5
G Quality Objectives - Where to start defining Quality Objectives? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
R Criteria for defining FMEA & Control Plan Critical and Significant Characteristics FMEA and Control Plans 10
V Defining Policies and Standards for In-License of Products US Food and Drug Administration (FDA) 2

Similar threads

Top Bottom