To Control or Not to Control - Answer Keys to Tests

P

pittmanl

#1
To control or not to control

The company I work for currently uses tests to certify Testers, QC Inspectors, Solderers, etc. We control the tests, but the answer keys are not controlled. I believe the tests and answer keys are two halves of the whole. Therefore, clearly, the answer keys should be controlled. I am meeting with resistance on this issue. There is a concern that we're controlling too many documents. A recent quote is, "Where does it stop!" We're also undergoing a reengineering of our Quality Systems, so I think these people are clinging to the status quo. Any thoughts, suggestions, alternate viewpoints, etc. are appreciated.
 
Elsmar Forum Sponsor
L

Laura M

#4
Same question, different example.

I remember from my original ISO training...way back....the example of the "Machinist's Handbook" if referenced by any employees, is required to be a controlled document. This would require an annual investment by a machine shop employee, or the company themselves. I recently rationalized that if the company procedures or job instructions reference the document, then it is up to the company to provide an updated version to the section of the document. If it doesn't change in the new rev, then the old book is OK. And if employees use as a guide, but not instruction, then an old copy is OK as well.

Has anyone out there experienced an auditor citing a non conformance for this type of document? I liken it to my Juran Quality Control Handbook. I'm not about to buy a new one every time a new version comes out.

Comments?
 
J

Jim Biz

#5
Had the same discussion with our auditor about a year ago ... Didn't actually write it up officially but his opinion was that they were "external specifications" (Juran handbook included.

Long story shortened - added a master list of publically accuired industry standard information to the system. Who had what edition of a machinist handbook - who had what edition of a Juran handbook - who had what steel mill "available size" catalog etc.

Reality .. this small issue fortified upper managements already poor opinion of the actual value of external auditing & the ISO system thing in general.

As I recall the words used were something like *B*S* - that just proves this whole thing is expensive time wasting *B*S* (I'm not sure they're over it yet : :) )

Regards
Jim
 
L

Laura M

#6
So having a list with the rev that existed was sufficient...not obtaining the latest revision? That doesn't sound right. That falls under the "just do it" to make the auditor happy. Easier to add to list than argue the practicality of it all!

At the most I was thinking one current rev on site or the list of changes that comes with the rev for folks to reference to ensure they had up to date information.

My Juran Handbook will stay at home :)
 

Marc

Fully vaccinated are you?
Leader
Admin
#7
I have avoided this by ensuring my clients are quick to tell the auditor that no decisions are based upon these documents. They are general reference books mostly used to check on basic standards and such (such as threads per inch for a certain screw) which rarely if ever change. As long as no one is making 'important' decisions based upon contents the book it is not subject to control nor is it necessary for everyone to get a new copy every time the book is revised.

> Long story shortened - added a master list of publically accuired industry
> standard information to the system. Who had what edition of a machinist
> handbook - who had what edition of a Juran handbook - who had what steel mill
> "available size" catalog etc.
>
> Reality .. this small issue fortified upper managements already poor opinion
> of the actual value of external auditing & the ISO system thing in general.

I agree with them. Controlling a Juran or Machinists Handbook is down right stupid. At best I would have 1 'Master' copy the company buys in the appropriate departmental 'library' where folks can go to check if information they are checking in their book is the same as is in the 'latest' revision.

Auditor interpretations continue to make inroads into the trivial as ISO 9001 evolves. The new version may prove to be more of a challange than many of us now realize due to interpretations alone.

> Easier to add to list than argue the practicality of it all!

The question is, when do you stop? A bunch of those 'easier to do it's' over a couple of years adds up to non-value added complexity - they become an expense. I have been in companies which were registered in the early 1990's where things were out of hand - totally out of hand -- and it was because every time the auditor had a 'good idea' they went ahead and 'did it so the auditor would be happy'. So every new auditor had a new 'this would be a good idea' and after 6 years or so it was a mess.

At most, for Machinists Handbooks, I would put in the document control procedure a statement which categorizes them such as: "Machinists handbooks and Juran handbooks are not used for decision making purposes, but rather are used for reference and as such are not controlled."
 

Marc

Fully vaccinated are you?
Leader
Admin
#8
> If a designer is using it to determine a tolerance or class of thread fit,...

That's why I stated above:

> At most, for Machinists Handbooks, I would put in the document control
> procedure a statement which categorizes them such as: "Machinists handbooks
> and Juran handbooks are not used for decision making purposes, but rather are
> used for reference and as such are not controlled."

If you use it for decision making purposes such as during design, that's another story. ANSI specs are also looked at critically by auditors as to their use as well. Much as live threads per inch or such in a Machinists handbook, most ANSI specs (such as a steel spec) are static.

The key is being ready to explain what you use, why its appropriate, whether it is revision sensitive and what you use it for. The key point is whether you use it for decision making purposes.

[This message has been edited by Marc Smith (edited 16 January 2001).]
 
A

Alf Gulford

#9
Agreed. The correct pitch diameter for a 1/2-13 thread isn't going to change, no matter what date the Machinery Handbook is printed. And so what if it did? What counts is whether or not the part being machined meets the print specifications - and those are controlled.

By their nature and usage, these types of publications are Reference Only and it's hard to believe that anyone would even question that.

On second thought (hence the edit notation), what we're saying is only true of Machinery Handbooks that the machinists themselves are using. If a designer is using it to determine a tolerance or class of thread fit, or how much interference is needed for a press fit, then I guess we're talking about a publication that needs to be controlled.

[This message has been edited by Alf Gulford (edited 16 January 2001).]
 
J

John C

#10
If a document, internal or external, is required by the QMS then it has to be controlled. '2000 4.2.3.
If it is 'required', it will be referenced in your documentation somewhere and, if it isn't referenced, then it cannot be part of the quality system.
However, there are many documents which are truely part of the quality system since they are regularly used to help make decisions, yet are general and their use is unpredictable and uncontrollable. If these are not referenced in your documented system, then that contravenes the rule that I stated above. But it is a good rule.
Here's my suggestion;
Option 1, Deny use and don't be drawn. But be aware that you might well be drawn to admit use, for example, if you do use Juran to help make decisions or upgrade your suitability for the job (and what other reason could there be for using it in working hours?), then you might find it hard to avoid being drawn into admitting that it is there for some relevant purpose.
Option 2, particularly for technical catelogues, manuals, etc, which are obviously used, call on 9001'2000 4.2.1 Note 2 c), The compentence of personnel; 'The personnel concerned are professionals, chosen for the job because they have the responsibility, experience and skills necessary to be able to make best choice and use of the available external information'.
rgds, John C
 
Thread starter Similar threads Forum Replies Date
L Audit Nonconformance - Not following Control Plan - How to answer Request for CA? Document Control Systems, Procedures, Forms and Templates 8
C Control Plan APQP and PPAP 4
D Control of Records ISO 13485:2016 - Medical Device Quality Management Systems 7
M Document Control - Applying Suitable Identification to Obsolete Documents ISO 13485:2016 - Medical Device Quality Management Systems 5
L Control of Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
S Control plan for "highly automated processes" FMEA and Control Plans 3
D Document Control Question involving DocuSign US Food and Drug Administration (FDA) 5
R SCORING OF MILLER MARITAL LOCUS OF CONTROL SCALE Coffee Break and Water Cooler Discussions 2
M Document Control ISO and FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
M Design Control Procedure Medical Device and FDA Regulations and Standards News 4
D 8.5.1.2 Validation and control of special processes requirements for Heat Treat External Processor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Humane Pest Control Food Safety - ISO 22000, HACCP (21 CFR 120) 1
B 8.5.1.1 Control Plan - question audit NC IATF 16949 - Automotive Quality Systems Standard 5
B QM Plan vs Control Plan IATF 16949 - Automotive Quality Systems Standard 3
N AS 13004 Control Plan and AQL FMEA and Control Plans 1
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 1
qualprod Traceability with no rules to control labels? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B Doubt about the correct control chart Statistical Analysis Tools, Techniques and SPC 14
G Change Control for Test Samples Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Z Change color or shape of individual data point in control chart Using Minitab Software 6
Z Setting the Control limits on Minitab Using Minitab Software 4
C Elaborating a control chart with skewed data Manufacturing and Related Processes 4
M Who is performing quality control? IATF 16949 - Automotive Quality Systems Standard 2
S Risk control through Information for safety ISO 14971 - Medical Device Risk Management 8
D Locking Control Limits and SPC Sample Sizes (AIAG/Automotive Requirements) Six Sigma 2
Q Control limits Six Sigma 6
J PFMEA/control plan question- PLEASE HELP ! IATF 16949 - Automotive Quality Systems Standard 8
T Control of Nonconforming Material AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
G Control of Approved Supplier List (ASL) When Employees Make Purchases Supplier Quality Assurance and other Supplier Issues 6
dpenbert AS9100 7.5.3 - Manual Document Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Y FMEA link to Control Plan frequency and sample size FMEA and Control Plans 19
D Control chart selection of multiple batches review Statistical Analysis Tools, Techniques and SPC 4
M Supplier Control for Unique Product ISO 13485:2016 - Medical Device Quality Management Systems 6
L Unique Supplier Control Issue AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Help in document control procedure Document Control Systems, Procedures, Forms and Templates 8
PQ Systems Understanding Capability and Control Charts Series Using SQCpack Software 0
PQ Systems Control Charts & Capability Analysis 101 Using SQCpack Software 0
D AS9100 Rev D - Clause 8.7 Control of Non conforming outputs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Linking control chart with control plan Statistical Analysis Tools, Techniques and SPC 5
T IEC 62304 : Risk control for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 8
N Change Control for processes & products Manufacturing and Related Processes 7
Q Change Control Numbering system Document Control Systems, Procedures, Forms and Templates 7
S Operation of possible rework in control plan FMEA and Control Plans 8
K MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics Japan Medical Device Regulations 2
D Using electronic lab notebooks in the design control process ISO 13485:2016 - Medical Device Quality Management Systems 3
M Process & Product Characteristic in Control Plan FMEA and Control Plans 17
D How to calculate the A4 constants in Median/Range control charts? Statistical Analysis Tools, Techniques and SPC 2
Nihls Quality Control (stability) Chart for CMM's - How the control limits are to be calculated Capability, Accuracy and Stability - Processes, Machines, etc. 2
M Change control on Tracking Sheet ISO 13485:2016 - Medical Device Quality Management Systems 11
K COPLANARITY: Composite profile tolerance on multiple surfaces- what does" lower dimensional reference frame tolerance" control? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11

Similar threads

Top Bottom