Is it acceptable or advisable to have a "Quality Systems Glossary"?

M

Mariep26

#1
Hi again,
Now that I have gotten the dreaded first post out of the way, the flood gates are going to open with questions (intelligent ones, I hope)

Here is my next one:

Is it acceptable or advisable to have a "Quality Systems Glossary" type document and simply refer to that in conjunction with ISO 9000:2005? Meaning any definition that is taken as is from the standard would remain in the standard and any definition specific to the organization is captured in the referenced glossary document.

Per my previous post, I am looking for ways to get the QM down from 52 pages and another heavy hitter is the terms section (3 pages worth)

Again any input or ideas would be much appreciated!
Marie
 
Elsmar Forum Sponsor
#2
Re: Terms and Definitions

Glad you've decided to 'jump in' - the water's fine!

In your own system, I wouldn't suggest it. Partly because, your QMS shouldn't be using terminology that is foreign to the users! The issue with ISO 9001 is that it doesn't use mainstream language that organizations use daily. It's also written for some 144 or more countries, hence the need for definitions. Your QMS should be written for you and yours...
 
T

treesei

#3
Re: Terms and Definitions

In my regulatory affairs world, definition and scope are the very first things to clarify before any discussion can occur. (Someone told me that this was also true to lawyers, which annoyed me.):)

:2cents:

1. Whenever possible, stick to the definitions given by the laws, regulations, or standards like ISO.

2. If there are org-specific terms or terms that the above authority sources did not define, it is necessary to define them within our own system to get everyone on the same page.
 
M

Mariep26

#4
Re: Terms and Definitions

Agree with both posts. Two follow on questions:
1) There is no need to repeat terms in your QM as they are in the standard in a terms and definitions section (frankly the term section in the current QM adds no additional value so I am questioning why it is there)
2) What is the best place to put any terms that are specific to the organization?
 
#5
Re: Terms and Definitions

Agree with both posts. Two follow on questions:
1) There is no need to repeat terms in your QM as they are in the standard in a terms and definitions section (frankly the term section in the current QM adds no additional value so I am questioning why it is there)
2) What is the best place to put any terms that are specific to the organization?
Most people who use the system have no care or clue about 'ISO', so I'm not sure about references to that. I can see the need for some references to regs or such like.

I prefer to see - in a document - the definition spelled out the first time it's used in that document, rather than the reader having to refer some place else: - "The auditor reports the observed NC (non-conformity) and then issues the NC report..." etc.
 
J

Jason PCSwitches

#6
Re: Terms and Definitions

Agree with Andy. They should be defined within the associated documents themselves, I wouldn't recommend an additional document (glossary). You can define them as they are used or add a definition section at the beginning of a particular procedure, either way less is more in this case.
 
T

treesei

#7
Re: Terms and Definitions

I prefer an additional "document" for definitions. Reasons: 1) A term may be used in multiple documents. for example, "first article" to engineering/quality; "process change" to change control. If a definition needs to be modified, it is easier to simply modify the glossary rather than individual documents. 2) When people need to clarify a definition but are not sure in which document it is, they can simply go to that "glossary" to find the answer.

Where will this "glossary" reside? It may be a formal document in the QMS. Or it may be electronical with a link on the company's internal website, with maintenance responsibility clearly assigned. The documents in which the term is used can be built in such a way that by clicking on the term in the e-copy of the document the system automatically takes the reader to the glossary.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
Re: Terms and Definitions

In my regulatory affairs world, definition and scope are the very first things to clarify before any discussion can occur. (Someone told me that this was also true to lawyers, which annoyed me.):)

:2cents:

1. Whenever possible, stick to the definitions given by the laws, regulations, or standards like ISO.

2. If there are org-specific terms or terms that the above authority sources did not define, it is necessary to define them within our own system to get everyone on the same page.
I agree. I am very much PRO glossary and acronym definitions in the first part of a document.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
Re: Terms and Definitions

Agree with Andy. They should be defined within the associated documents themselves, I wouldn't recommend an additional document (glossary). You can define them as they are used or add a definition section at the beginning of a particular procedure, either way less is more in this case.
In general I agree. However... Sometimes it really helps to have a "single source" glossary document. Example: FORD Acronyms (aka 'Initialisms' - Not Always True Acronymns) List

Also see:

Quality / acronyms brainteaser - Awkward transitions from written to spoken
Quality Assurance Terms Glossary
 

Attachments

Jim Wynne

Staff member
Admin
#10
Hi again,
Now that I have gotten the dreaded first post out of the way, the flood gates are going to open with questions (intelligent ones, I hope)

Here is my next one:

Is it acceptable or advisable to have a "Quality Systems Glossary" type document and simply refer to that in conjunction with ISO 9000:2005? Meaning any definition that is taken as is from the standard would remain in the standard and any definition specific to the organization is captured in the referenced glossary document.

Per my previous post, I am looking for ways to get the QM down from 52 pages and another heavy hitter is the terms section (3 pages worth)

Again any input or ideas would be much appreciated!
Marie
The problem with many (if not most) glossaries is that the people who write them can't write, and the definitions wind up causing more confusion than they alleviate. Here's an example of definitions of two terms from a glossary I got from a supplier a while back:

FA = First Article (First Piece) – Piece part layout 100% to all features listed on PPAP DWG product drawing.
ISIR = Initial Sample Inspection Report – Similar to FA, this uses 2 to 5 for 100% layout on PPAP DWG product drawing.

I think the person who wrote those knew what he meant, but I sure don't, and I was afraid to ask. :tg:
 
Thread starter Similar threads Forum Replies Date
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
M Measurement Error - How to determine what is acceptable? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
M Are Fungal counts acceptable in class 1000 clean rooms? Other ISO and International Standards and European Regulations 2
T ISO 14971-2019 doubt - Evaluate if estimated risks are acceptable ISO 14971 - Medical Device Risk Management 9
samer Acceptable limits for Spills - Tracking Hydraulic Spills ISO 14001:2015 Specific Discussions 3
V Acceptable maximum RSD (relative standard deviation) for an sample size Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
B Gage R&R Acceptable (10-30%), deduct Total Variation from Tolerance Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
Q Acceptable calibration accuracy of a 60" linear measuring device General Measurement Device and Calibration Topics 16
F It is acceptable moving remote locations staff to manufacturing plant for auditing? IATF 16949 - Automotive Quality Systems Standard 3
Q Is it acceptable to mix components from two different lots into an assembly? ISO 13485:2016 - Medical Device Quality Management Systems 1
C Acceptable NDC for %GR&R part inspection to Tolerance (%Tolerance) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
D Risk Register - have we considered enough and is the format acceptable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Operator Checks - How to show that they were completed on a checklist as acceptable IATF 16949 - Automotive Quality Systems Standard 2
C Example Work Instruction/Procedure for AQL (Acceptable Quality Level) AQL - Acceptable Quality Level 4
S Dates on Labels acceptable to the USA - GS1 General Specification 3.4.4 Other US Medical Device Regulations 3
E Root Cause Analysis - Is Insufficient Understanding an acceptable Root Cause? General Auditing Discussions 9
W Unattached (stand-alone) Forms acceptable for AS9100C? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
V Why Gauge R&R 10% is acceptable for variable instruments ? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
X Acceptable methods to store and archive records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Is it acceptable to audit to the Nuclear Principles? Quality Manager and Management Related Issues 9
I Is it acceptable it is to list new products under an existing 510(k)? Other US Medical Device Regulations 14
S If this EN ISO 11137 certificate acceptable for Contract Sterilization? ISO 13485:2016 - Medical Device Quality Management Systems 2
D What is satisfactory & acceptable for Coliform - Staphylococcus - Hands and Surfaces Food Safety - ISO 22000, HACCP (21 CFR 120) 3
S Is a Dynamic Controlled Form acceptable per 21CFR820 Document Control Systems, Procedures, Forms and Templates 3
C Lowest Acceptable Grade for Master Gage Set Calibration and Metrology Software and Hardware 1
B Digital Signature Solutions acceptable to use in an FDA Medical Device Environment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Is a ndc less than five is also acceptable? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
T Technical regulations that determine the acceptable limits of cigarettes General Measurement Device and Calibration Topics 4
L IEC 60601-1 3rd edition Clause 9.2.2 Trapping Zone (Acceptable Gaps) IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
N Is it acceptable to sterilize products without claiming and labeling "sterile" ? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Quality Objectives - Acceptable Levels and Functions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
C What is an acceptable bioburden level or count when working in cleanroom ISO class7 ISO 13485:2016 - Medical Device Quality Management Systems 1
D Is embedding documents within a Contract an acceptable practice ? Contract Review Process 9
B Non Acceptable % Tolerance Result - Decrease Sorting Limits Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
F ANSI ASQ Z1.4 - Is the following process acceptable? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
C Maximum acceptable Tolerance - Uncertainty Ratio (TUR) General Measurement Device and Calibration Topics 2
S Is it acceptable to have an ASL for Critical suppliers alone? Supplier Quality Assurance and other Supplier Issues 4
S Is this Quality Policy acceptable in the context of ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 24
A Help with acceptable screw gage values per standard BS 919 for Go/ No Go gage General Measurement Device and Calibration Topics 4
S What are typical Acceptable Quality Levels (AQL) adopted in Food industry? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
somashekar Who can provide a WHO GMP certificate in India acceptable to the CDSCO Other Medical Device Regulations World-Wide 6
D Root Cause and Corrective Action - Is our Practice Acceptable? ISO 13485:2016 - Medical Device Quality Management Systems 5
W Application of AQL (Acceptable Quality Level) Concept AQL - Acceptable Quality Level 15
H Acceptable Time to provide proof of CAR (Corrective Action Report) Nonconformance and Corrective Action 4
A Sample Size for Mathematical Model with acceptable Confidence Level Using Minitab Software 7
M AQL (Acceptable Quality Level) for Mixed Part Defect IATF 16949 - Automotive Quality Systems Standard 1
C Comparing Two Test Methods - Acceptable Difference(s)? Statistical Analysis Tools, Techniques and SPC 3
S AQL (Acceptable Quality Level) Report Form example wanted AQL - Acceptable Quality Level 1
M What is an acceptable PPM for large volume fasteners? APQP and PPAP 6
K How do you determine what is acceptable base on an FMEA RPN FMEA and Control Plans 6
Similar threads


















































Top Bottom