Establishing/Revamping Training system

R

Rajman

#1
I am looking for input or for someone to point out some good reference material in establishing & operating a training system (to satisify ISO 9002 - Element 4.18).

We currently have a "system" set up but it functions poorly if it functions at all. We were registered to 9002 last fall. The registration went smoothly till the auditor hit the training element and then "the tap-dancing started."

Any recommendations or guidance would be DEEPLY appreciated.
 
Elsmar Forum Sponsor
A

Al Dyer

#2
I would suggest starting a continuous improvement project to determine how to improve the system. I've "tap-danced" in the past and it isn't fun.

Maybe you could post some examples of any specific areas that need improved.

If you realize you were tap dancing, I'm sure the auditor will be looking for improvements on a surveillance audit.

IMHO

Asd...
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
You have to identify and segregate your training.

Example:

You have a certain amount of training that HR (typically) does when a body is 'brought onboard'.

Each department probably has department specific training.

Many times there is equipment specific training.

This said, there are typically a number of training responsibilities. My take when I first hear someone say this is there is a low level of importance attached to business needs. Some questions: Is upper management supporting training needs? Are training issues being brought before management review and other meetings? Do most management people in your company see the training requirements as bunk?

Often training is one of those necessary evils which people place a low priority on. And to me its sad, because training is so important.

It may be that your registrar will force upon your company some discipline and organization with respect to training. This may be the project Al suggests.

I haven't had any clients with training issues in a few years, luckily. But I have, in the past, seen training as an albatross that the client really struggled with. Most often it's management who wants to shove someone at a machine or whatever and 'get on with it'.

If you want to give us some details, maybe we can target a bit better.
 
R

Rajman

#4
A "brief" overview of the current system.

One aspect of the training is that all employees are responsible for reading the 2nd level procedures applicable to their work. This hasn't worked out too bad except the HR person who is supposed to track what everyone has read and when new revisions are issued hasn't been keeping up (but that's another story). I would like to add keeping track of training for 3rd level procedures (those procedures for specific job-related tasks).

The other aspect of the current training program is that "managers" keep track of their employee's qualifications (these are to be listed on a form).

Job titles were established to define responsibilities by them. Each person holds at least one title and some employees have up to seven titles.

Here's the problem. We are a small company, around 28 people. Employees perform multiple tasks outside the normal scope of their jobs. Such that a lady that does soldering and wiring might also be qualified to do q.c. inspection. So who holds the form? The manager who directs her in soldering/wiring or the quality manager? The quality manger is unaware of what she is working on since she is directed by the soldering/wiring manger. Expand this across the whole company and you can only imagine the confusion. After a while is seems like everybody is the manager of everybody else.

I can see how this all started. My company attend an ISO co-op which was lead by an ISO consultant. The system would work great if you have one person having only one manager or supervisor. In a small company - No do work. I know the obvious answer is tailor the system to fit the company. That's why I'm looking for input.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
> So who holds the form? The manager who directs her in soldering/wiring or the
> quality manager?

It depends upon the level of discipline and control you have and want. If you want to make sure you have strict control I'd use the Quality Manager as a central focus.

Typically, however, I recommend managers be responsible. When someone works under multiple managers, each manager would have the record for training applicable to processes under that managers control. Any given empoyee may be listed on several managers training sheets.

This is to say manager A is responsible for process a, b and c. Manager B is responsible for processes d, e and f. Each manager is responsible for documentation relevant to their processes. Where you have documents in common - make a matrix and do that training upon hire. For example, everyone has to understand their role in the nonconformance system. So - train new hires on it. Document control is another procedure to train as they come in the door.

You could give new hires an uncontrolled copy of you QA manual and level 2 procedures and tell them to 'know' them.

> The quality manger is unaware of what she is working on since she is directed
> by the soldering/wiring manger.

I'm not sure what you mean by this.

To be honest, it sounds like you're over complicating this and/or folks are shirking some of their responsibilities. Training and associated records in a 28 employee facility shouldn't be much of an issue.
 
E

energy

#6
No matter where they work or for who, procedures must be read and understood. My proposed method is to utilize a document acknowledgement form. This form will be kept for all levels of documentation. During a customer audit, the auditor asked "How do you know that the employee read and understood the document?" My supervisor produced the form used and all the objective evidence, signed and dated. Was it effective?
The auditor thought so.

"I acknowledge receipt of all the procedures/documents as shown above. Furthermore, I am aware of the procedures/documents pertinent to this position of this department should be used as a reference on a regular basis."

When a change to the procedures is issued, the following clause is added "Replace affected pages as shown above and return the obsolete pages to the Quality Assurance Dept. for review and disposal, per QP-205-03 Revision Control of Quality Documents para. 5.4.3.
 

SteelMaiden

Super Moderator
Super Moderator
#7
Try not to make the training requirement and documentation harder than it has to be.

1. You have your "job descriptions". Sit down with appropriate managers and list the basic requirements and skills. Decide which are a pre-requisite for getting the job and which can be trained for.

2. Use this as a checklist for training documentation along with your list of items trained for during orientation.

3. Those skills that the employee has when they come to you can be so noted by the manager that made the decision to hire him/her.

3. As each job or skill is mastered, the employee and the qualified trainer initial or sign off and date that item.

4. Keep a list of employees "in training" and review where they are in their training at some specified interval. This should be done by managers the employee reports to along with whomever is in charge of your training program.


5. Make sure that you have your procedure documented (but not overdocumented).

This works well and is very easy to live with. If your documentation is recorded in a computer program, you should be able to generate your check-off sheets easily. If your training documentation is done only on paper, all you need to do is copy you "job description" and use it as the check-off. Each manager is responsible for assessing only those jobs under his authority, yet the employee's training file will contain documentation of all the jobs or functions s/he is qualified to perform.

Believe me, the corporation I work for understands multi-tasking and cross training! I have done everything from loading trucks, maintenance work, computer and network installation and administration, production, and QC/QA testing and inspection, auditor, training coordinator, safety program administrator and janitor, all while being the quality system manager.

In over ten years of audits including ISO and QS we never had a nonconformance directly against training. We did, internally identify some training issues as root cause of other nonconformances, but hey, that's why you audit - continuous improvement.
 
Thread starter Similar threads Forum Replies Date
A Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
K ISO 13485 section 5.3 Quality Policy - No framework for establishing and reviewing quality objectives ISO 13485:2016 - Medical Device Quality Management Systems 2
N Use part of high risk device for establishing low risk device EU Medical Device Regulations 0
J ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence ISO 13485:2016 - Medical Device Quality Management Systems 6
M Establishing a FTQ (First Time Quality) process for an engine assembly line Quality Tools, Improvement and Analysis 1
R Establishing the quality policy for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
N Establishing a monthly scrap cost target Lean in Manufacturing and Service Industries 11
T Establishing -F- datum - need advice Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
S Establishing a Gage R&R Studies Program in a Testing Laboratory Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
M Establishing traceability from calibrated glassware to non calibrated ones General Measurement Device and Calibration Topics 5
O Establishing SPC for small batches of 10-15 units Statistical Analysis Tools, Techniques and SPC 10
M Establishing Metrics - Where do you document metrics? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
alonFAI Establishing a Receiving Inspection Procedure Document Control Systems, Procedures, Forms and Templates 5
optomist1 Establishing Sigma or Capabilty Indices for Automotive Safety Quality Tools, Improvement and Analysis 1
S Establishing an MSA Plan and Justification Suggestions wanted Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
M Establishing a QMS - What Daily/Weekly/Monthly activities in Auto Industry IATF 16949 - Automotive Quality Systems Standard 4
T Help establishing a good Customer Complaints Procedure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Process Validation Guidance establishing the Integration with QbD - April 2012 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
M Establishing Ranges for Weights for Calibration Verification of a Micro-Balance Calibration Frequency (Interval) 1
D Preparing for ISO 29001/API Q1- Establishing Control Features Oil and Gas Industry Standards and Regulations 3
D Establishing Key Process Characteristics (KPC's) Quality Tools, Improvement and Analysis 6
C New Quality Manager - Establishing Teams in different Business Units Quality Manager and Management Related Issues 4
H Noob Frequency Distribution and establishing achievable goals Using Minitab Software 2
K How to apply IEC 62366 and what shall be changed in establishing a Technical File ISO 13485:2016 - Medical Device Quality Management Systems 2
M Establishing monthly production targets with varying number of employees Lean in Manufacturing and Service Industries 6
A Why do I need batch size in establishing control plan to certain AQL?? AQL - Acceptable Quality Level 4
E Need help establishing a DMR (Device Master Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Basis for Establishing Gage Tolerancing - "Gage Maker's Tolerances" General Measurement Device and Calibration Topics 4
K Establishing the Environmental Aspects and Impacts for a Septic Tank Miscellaneous Environmental Standards and EMS Related Discussions 5
M Establishing simple procedure and work instruction using chart or photo or video Document Control Systems, Procedures, Forms and Templates 2
L Criteria for Establishing Control Plan Sample Size and Inspection Frequency FMEA and Control Plans 7
K Inventory Management - Establishing a procedure for Inventory Management Document Control Systems, Procedures, Forms and Templates 2
K Establishing Item Codes for Production Raw Materials Misc. Quality Assurance and Business Systems Related Topics 2
O Establishing the current value of KPI's (Key Performance Indicators) Manufacturing and Related Processes 1
Y Establishing and Measuring Individual Performance to Product Quality Standards Misc. Quality Assurance and Business Systems Related Topics 5
C Establishing alert and action limits for clean room bioburden Other Medical Device and Orthopedic Related Topics 9
E Establishing a biocompability test lab for testing EN 10993 series EU Medical Device Regulations 1
D Establishing and controlling process capability - Meaning of Phrases Capability, Accuracy and Stability - Processes, Machines, etc. 2
P Establishing Thickness Specifications from Measured Data Capability, Accuracy and Stability - Processes, Machines, etc. 11
A Initial condition for establishing significant environmental aspects Miscellaneous Environmental Standards and EMS Related Discussions 1
S Establishing Control of Regulations that concern my company Quality Manager and Management Related Issues 12
D Establishing New Training Procedure - Past Training of Existing Employees Training - Internal, External, Online and Distance Learning 6
J Establishing Proposal Metrics in a Factory Construction Company Quality Tools, Improvement and Analysis 6
A How to do Equipment Validation - Establishing our ISO 13485 QMS procedures Qualification and Validation (including 21 CFR Part 11) 26
B True Position without tertiary datum? Establishing a proper rotation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
Coury Ferguson Interpretation of IAF Guide 62 - Establishing the Competence of the Auditors Registrars and Notified Bodies 11
S Establishing Internal Audit Nonconformity Level Criteria - Major vs. Minor? Internal Auditing 46
H Establishing Employee Competencies and Training - Future Training Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P China - Establishing Quality Systems for Chinese Suppliers Supplier Quality Assurance and other Supplier Issues 8
Q Feedback System (8.2.1) - Requirements for "..establishing a documented procedure..." ISO 13485:2016 - Medical Device Quality Management Systems 5
Similar threads


















































Top Bottom