SBS - The Best Value in QMS software

How Can I Evaluate and Document the Competence of an Employee?


Ken K


ISO is putting an emphasis on employee competence in their revised specifications.

How would you evaluate the competence of an employee?

How would you document the competence of an employee?

And finally...who in your opinion shall determine if an employee is competent

Employer or auditor?
Elsmar Forum Sponsor
The employer calls it.

Ok… I’ll bite….


I would ask myself if the employee is able to perform the task at hand. If so, you have a competent employee.


Lack of competence should lead to a training and / or education plan.


The employer hired the person, in order to get a job done. The employer shall also determine the necessary competence for the employee. Of course the auditor can voice an opinion, but the employer must determine if the employee is competent.


Mike S.

Happy to be Alive
Trusted Information Resource

I agree with Claes.

You probably already do this so don't sweat it. The employer, usually the employee's trainer, supervisor or manager, determines competence. Can they do the job properly?

To document, we do a simple form where we list the employee's name, the task(s) they are "certified" or "authorized" to perform, the trainer's/certifier's name, date, and signatures.

Make sense?

Ken K

Makes Sense

I'm writing a procedure to cover Section 5.2 in ISO 17025.

We currently do a yearly employee evaluation. It covers job performance, goals accomplished, job responsibility priorites, an assessment of potential, training / educational needs, goals for upcoming evaluation period.

So I guess we have everything covered. I'll just insert a link to the form we use.

I always get this nightmarish scenario running through my mind before an audit. As we're going through the audit, the auditor screams out..."you incompetent *******!"

Mike S.

Happy to be Alive
Trusted Information Resource

Understood about the stress.

All I would add is a reference to how you evaluate employee competence in the beginning -- when deciding whether or not to hire -- and then how you decide when they can start to make product/do their assigned tasks on their own (before the first yearly evaluation). Then I think you're covered, but I'm not familiar with ISO 17025. Good luck.


Hey Ken,

If you are doing yearly employee appraisals then you probably have competence covered.

I had a problem because our Union contract does not allow annual performance reviews. :frust: Therefore, we had no appraisal format.

My management kept pointing to training records, thinking that training alone makes you competent. It took awhile to get the message across that being able to do the minimum tasks required for a job makes you qualified…being able to perform those tasks effectively over time makes you competent. You cannot determine competency the day that training is completed.

We came up with a simple 1 page form that is filled out by the Floor Supervisor once a year to cover it. It doesn't violate the contract, and it isn't a review. It's just documentation.
KISS Principle

For the training part of the new hire competency we modified our training checklist to add a column the supervisor or senior operator doing the training initials indicating the individual demonstrated the skill properly.

On our annual performance appraisals we added a line on the sign off sheet the employee and supervisor signs that says the employee is competent in thier job. If the employee is not competent, then there is an area to develop a training plan.

So all we did was add a column and a line. We did also talk with the supervisors and the senior operators to let them know what the expectations were for the new areas. We got little to no resistance to the changes. :D
Minimal documentation

I have a client that has about 20 folks. They built a matrix showing the tasks and the names and then rate the employees on each task (whether they perform it or not). The rating is:

0 = Unaware of task
1 = They have awareness, but cannot perform
2 = They can perform, but need supervision
3 = They can perform without supervision
4 = They can instruct others

A number 4 doesn’t have to be an expert, and a number 3 might be an expert. To get to number 4 the employee must be able to show they have the ability to train others (patience, communicative skills, etc)

That is the only documentation they have, unless someone attends a class and comes back with a piece of paper. The supervisors are responsible for deciding who is at what level and changing the level as time progresses.


Quite Involved in Discussions
More confusion!!! 6.2.1 tells one that you should be competent on the basis of the 4 listings. So, a signoff that you hired based on 1 or more of the 4 competencies (e.g. hired a welder based on his welding cert.). 6.2.2 b) or take other actions to satisify these needs. What are other actions?? C) says you must evaluate the effectiviness of actions taken. So, if you read the standard if one trains and takes no other actions, no evaluation needed. Just one take on it and of course the employer determines competence.


Every situation is different, and Registrars have varying interpretations, however...

I believe that competency has to be evaluated from time to time. Situations change: people get moved to other jobs and get rusty, people age and lose agility (I can attest to that one!):biglaugh: and tools, materials, and technology change. One time training will not ensure that the trainee remains competent over time.

That's why we have to renew certifications and licenses periodically.

So an approach that relies on a static assessment doesn't really address the issue of competency over time. I think to meet the spirit of the requirement, we must have a periodic method for determining competency.
Thread starter Similar threads Forum Replies Date
T ISO 14971-2019 doubt - Evaluate if estimated risks are acceptable ISO 14971 - Medical Device Risk Management 9
Watchcat CERs Literature Databases - Searching for data to evaluate EU Medical Device Regulations 16
K ISO 17025:2017 clause 7.6.2 - Performing calibration of its own equipment shall evaluate the measurement uncertainty ISO 17025 related Discussions 6
M Informational US FDA final guidance – Utilizing Animal Studies to Evaluate Organ Preservation Devices Medical Device and FDA Regulations and Standards News 0
L How to evaluate the process capability of a data set that is non-normal (cannot be transformed and does not fit any known distribution)? Capability, Accuracy and Stability - Processes, Machines, etc. 12
M Minitab tool to evaluate PM (Preventive Maintenance) process Using Minitab Software 6
M Informational USFDA – Efforts to evaluate materials in medical devices to address potential safety questions Medical Device and FDA Regulations and Standards News 0
qualprod To Evaluate Effectiveness in All Improvements? (ISO 9001:2015) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
H Evaluate Contingency Plan for Equipment and Tools IATF 16949 - Automotive Quality Systems Standard 4
qualprod Propose Aspects to evaluate risk impact? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q How to Evaluate Internal Resources for Training ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Source of practice to Evaluate Risks? (ISO 9001:2015) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S How to evaluate "competency" of consultants ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Jen Kirley How to evaluate hazards in using bar code scanners in chemical manufacturing Occupational Health & Safety Management Standards 1
A Creating a policy to evaluate the Third Party Security IEC 27001 - Information Security Management Systems (ISMS) 4
C How to evaluate the Detection Ranking of a new Design Control FMEA and Control Plans 1
G How to Audit or Evaluate our suppliers? We are not AS 9100C certified. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Q Format to Evaluate the Effects of New Processes and Equipment Manufacturing and Related Processes 4
K Validity of Using NCR's to evaluate Performance Nonconformance and Corrective Action 7
T Why evaluate Suppliers that are Brands we represent? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
E Using ANOVA during the PQ Validation Run to evaluate Statistical Differences Statistical Analysis Tools, Techniques and SPC 4
N The right method to Measure and Evaluate a Flatness Callout Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S How to Evaluate a Calibration Report Certificate General Measurement Device and Calibration Topics 8
J Web based Database to Collect and Evaluate 5S Audit Results, Trends, Charts Lean in Manufacturing and Service Industries 3
S Required to Assess and Evaluate all Suppliers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W How you can evaluate ISO 9001 Certification Body (CB) Auditors during their visits? Registrars and Notified Bodies 19
B How do you evaluate courses - eg. Awareness Training, Concept etc. Training - Internal, External, Online and Distance Learning 3
M How to validate a Dye Test method used to evaluate Package Integrity Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
R Can manufacturer separately evaluate the clause 14 (PEMS) of 60601-1: 2005? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
S Training Efficiency Assessment - Evaluate the Effectiveness (Clause 6.2.2 c) Training - Internal, External, Online and Distance Learning 3
somashekar Definition Evaluate and Select ... What are the most common understandings of these words. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 12
B Our suppliers are retail shops - How to evaluate OTS (Off the Shelf) suppliers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Do I evaluate my supplier when he doesn't have delivery in that month? Supplier Quality Assurance and other Supplier Issues 10
0 Best way to evaluate the differences between 2 gauges Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
B Distribution of Procedures to the copy holders (evaluate my matrix) Document Control Systems, Procedures, Forms and Templates 16
S How to evaluate the Effectiveness of Corrective and Preventive Actions Nonconformance and Corrective Action 3
B How to Evaluate Competence of an Internal Translator ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Board of Directors - Their duties and how can we evaluate them? Misc. Quality Assurance and Business Systems Related Topics 8
B What happens if we evaluate supplier as not approved and there are no anothers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
L Weighing plastic part to evaluate moulding process Design and Development of Products and Processes 2
J Approved Supplier List - Required to evaluate every supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
S Supplier Quality Rating - What to evaluate Supplier Quality Assurance and other Supplier Issues 11
U MSA Roadmap - Is there an order in which to evaluate a measurement systems Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
K How to evaluate or measure the complexity of product? Manufacturing and Related Processes 8
V Should We Evaluate Suppliers on a Regular Basis or only when Issues Arises? Supplier Quality Assurance and other Supplier Issues 7
R Evaluate Customer Satisfaction without having to send questionnaires Supplier Quality Assurance and other Supplier Issues 2
B Evaluate Compliance to AS9100 Paragraph 7.6 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
J Evaluate a business or organization - Need case study for school! Coffee Break and Water Cooler Discussions 16
K The 'Cohen's kappa' method to evaluate degree of consensus between visual operator Six Sigma 9
D Which Indicator is Best to Evaluate our HR Training Programs? Training - Internal, External, Online and Distance Learning 7

Similar threads

Top Bottom