Help! Are Training Docs part of the QS?

S

Shannon - 2007

#1
Hi all,
I thought I knew this, but now our Home Office folks are changing things.:mad:
During a recent assessment, it was determined that our QS was too complex. We have approx 400 total docs in our QS (procedures, work instructions, forms). Much of these are detailed work insructions that we use to train associates with.
Here is what they want to do.
Review all docs to determine if they directly satisfy a requirement. If they do, keep in the QS. If not, they will become "training docs" that sit outside the QS, meaning that they will not reside on our Master Control Document nor will they be controlled using our QS Document Control methods. An example of a work instruction that doesn't directly meet a requirement would one that explains how to properly operate a palletizer.
This has raised several questions in my mind.
Is this coool? Can we really do this? Has any other Company taken a similar approach?
Most importantly, I'm concerned about the control of these docs. If we leave it up to the individual department managers to ensure that thier training docs are current, we may end up back to where we started from. Maybe I'm a control freak or paranoid, but this doesn't feel right.
The other advantage, they say, is that if the training docs are not part of the QS, they are not subject to being audited. Is this true?

Thoughts anyone?
Remember, if I push back, I better have a suggestion to help reduce the complexity of our QS.:lick:
 
Elsmar Forum Sponsor
D

David Mullins

#2
Yes, you can make these non-auditable "guidance" documents.
We'd love to control them, but, the economic returns just don't materialise to warrant all the extra time and effort.

You can call the "GUIDES".
And still kind of control them via dates, numbers, whatever - a win/win?

Good luck - according to our production planning manager luck is a standard requirement for our plant to operate at a reasonable and consistent level!?!?!?! What the......?
 
#3
Lean system

Hullo Shannon,

I can certainly sympathize with the wish for a lean system. I agree with Jim that the prudent course of action would be to find out what you need in your system.

Otherwise there is an obvious risk that you throw the baby out with the bathing water....

/Claes
 
#4
David Mullins said:

---X---

Good luck - according to our production planning manager luck is a standard requirement for our plant to operate at a reasonable and consistent level!?!?!?! What the......?
Wow David,

I'll be interested in hearing about what happens when his luck runs out?;)

/Claes
 
R

Randy Stewart

#5
What's Needed

Agreed, you must look at how deep the instructions really need to be. The standard never states that you should have instructions so that the receptionist could run the NC Mill in a pinch!
You put employees in positions that they are skilled and qualified to perform certain tasks, therefore the training has already been done. In that sense the instructions are there for reminders. What we have done is taken our process flows and hyperlinked the "Training Instructions" to a box in the flow. If a new person is hired they have all the information at a click to perform the op. When the auditor is here they view the process flow, if any questions are brought up all the individual has to do is click and there are the blank form, training (work) instructions, etc.
We have found this to be especially helpful in Inspection with the different requirements for both manual and CMM.
One other benefit is that the department is then responsible for the document control and the system person controls the process flow. It took awhile to get the buy in, but now they have fully accepted it. It gives the department managers more flexibility in changing training or work instructions based on customer requirements (VTTO's, PIST, etc) and the skill level of their personnel.
 

SteelMaiden

Super Moderator
Super Moderator
#6
Re: Re: Help! Are Training Docs part of the QS?

Jim Wade said:

So many organizations have 'procedures' that aren't in daily use by people (which means they aren't procedures at all!) rgds Jim
Jim,

Aren't the things that are not used every day more important to document than the ones that are used every day? It's those things that only get used once a month that have people scrambling trying to find notes and crib sheets, and yes they are procedures. Just because you don't use them every day doesn't mean that they are not important to the operations/quality system.

Am I missing something here? I tell my people not to worry about the things they can do blindfolded. Those are learned by everyone who might possibly have to do the job, they are easy, intuitive and fairly self explanatory. On the other hand, if you have to dig into the bottom drawer of your desk to figure out what you are supposed to do, nobody else is going to know how to do it if you are gone for some unforseen reason.

Please tell me your reasoning for saying that something that is not done every day is not a procedure? (by procedure, I am looking at it from the standpoint of the actions themselves, not just the documentation, is that where we are going in separate directions?)
 
#7
Shannon,
Sounds like an excellent idea. We done the same thing with our documents. We now allow each department manager/supervisor to control their own documents/work instructions to a common procedure. It greatly improved our level of control.
 
#8
Jim, I like your summary.

"Think 'information' and 'communication' - not 'documentation'!"

That need sto be posted in each managers office.
 
S

Shannon - 2007

#9
Thanks all for the feedback.
It has been very helpful.
My questions regarding if these training docs are "auditable" and that other Companies have taken this approach successfully, have been answered. That makes me feel better about the approach.

:)

Steel Maiden has raised some very good questions that also concern me. It seems that the less routine a "procedure" is, all the more reason to document it. If we all agree that a document is needed, then the only answer left is.....is this doc a QS procedure or is it a training document, even though it gets used well after training was conducted.

Keep it coming, it's all good!
 

SteelMaiden

Super Moderator
Super Moderator
#10
Shannon said:

even though it gets used well after training was conducted.

Keep it coming, it's all good!
Hi Shannon!

I could say that you've answered your own question, but each of us needs to define what it is we want OUR OWN quality system to be. Now, I don't want to turn this into a fray folks, so bear with me.

If, and it is a big if, the goal of your system is compliance to a standard and its accompanying certification then stop at the compliance issue. If, on the other hand you are an idealist and think that a quality system should provide value, both monetary and culturally, then you need to think beyond the standard. Sometimes it is a battle, especially when you work with others that know the standard. You'll get the "that is not a requirement" and they will be right. Myself, I'd make it a procedure if it is referred to in performing the job, even if it is not one of the "6" required procedures.

The beauty of ISO 900X is that you can make as much or as little of it as you choose. Personally, I couldn't give a rat's posterior if we ever got certified, what I care about is that we provide product that meets the customers' expectations, both internal and external, so we can continue to grow. Quality is not only about the product, but our safety, our environmental stewardship, our relationships with co-workers and also family. i.e. quality is a way of life, not some certificate on the wall.
 
Thread starter Similar threads Forum Replies Date
A Training Program Help - Old docs, new docs, so many docs... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Help me build an Excel Spreadsheet for tracking training Training - Internal, External, Online and Distance Learning 14
M Training to help Familiarize myself to the Standards and the way these systems work AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J Technical Writing - Help Training Supervisors in the Basics Training - Internal, External, Online and Distance Learning 6
B Need help tracking training for my business Quality Assurance and Compliance Software Tools and Solutions 3
M Help with TS16949 Awareness Training for Employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Document Version for Website Help/Training 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Please help me define training requirements for a Career in Regulatory Affairs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K ASQ Certified Quality Inspector (CQI) Training Help Training - Internal, External, Online and Distance Learning 6
6 Preventive Action - Help Needed. Input for Training and Sustenance Preventive Action and Continuous Improvement 3
B 8D Evaluation Help? Rolling Out 8D Evaluation Training to a Team Nonconformance and Corrective Action 5
S Seeking Help with FDA GMP Device Training Training - Internal, External, Online and Distance Learning 8
K Training package to help train operators how to use a measuring devices properly General Measurement Device and Calibration Topics 8
A Looking for AS9102 On-Line or Third Party First Article Training "Help Sidney" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Designing an ISO 9001 Internal Audit Training Course - Need Help Internal Auditing 6
C Internal Audit Training Help - Audit Nonconformance Training - Internal, External, Online and Distance Learning 11
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
S Need help with analysing a survey on minitab Using Minitab Software 1
M Help me improve the definition for internal PPM Manufacturing and Related Processes 3
I Help: QFD House of Quality Quality Tools, Improvement and Analysis 1
C New to Site - Request Help with API Q2 Implementation Oil and Gas Industry Standards and Regulations 10
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
K A proposal for the model Quality Management - I need help for the project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q % Study variation low, % tolerance high - GR&R Interpretation help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
M Thanks for the help Coffee Break and Water Cooler Discussions 0
Judy Abbott Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
A Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
8 Need Help - Runout - Function Gage Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T Burn out - Tips to help combat QC burnout Career and Occupation Discussions 9
Emran.mi Measurement system analysis - Can you help me about implementation MSA for CMM device Manufacturing and Related Processes 2
S New to FAIR, need help in filling it out AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Informational From RAPS: Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance Medical Device and FDA Regulations and Standards News 0
M Reliability Testing - Weibull Analysis Help Reliability Analysis - Predictions, Testing and Standards 4
L Help me to decide which test to use - If each proportion belongs to the same population Using Minitab Software 7
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
T QMS Template Help - Small machine shop/job shop Manufacturing and Related Processes 1

Similar threads

Top Bottom