SBS - The best value in QMS software

Documentation of Competency, Awareness

A

Af7082a

#1
Hello,

I was wondering if people could share how they are documenting that individuals are competent in their position and also what you are doing in terms of awareness? We had an auditor come and speak with our company and we are weak on these areas. We are thinking of implementing a 90 day review form with a sign off in terms of if the individual is competent or not. Is anyone willing to share what you are doing in these areas? I'm a member of HR and new to this system, however how department is partially responsible for these items. If anyone is willing to give any advice, please reach out.

I'm also new to this board so please let me know if there is a better place for this question.

Thank you!
 
Elsmar Forum Sponsor

jack770214

Involved In Discussions
#2
We have a company level quality online training class for quality awareness, it discusses how their jobs affect quality and the possible effects if (customer's) requirements are not met. Its a very short training and people have to take it once every 18 months and we try to keep the material relevant with current events and issues.

Sent from my LGMP260 using Tapatalk
 
U

Ursula_D

#3
In our company competence of employees is documented/proved by detailed training plans and overviews, training assessments through participants, skills matrix ( required/existing skills) for each department, detailed job descriptions. Awareness is documented/ proved fory example through publishing ( online Intranet and on notice boards ): KPIs ( regularly in minimum once per month ), company and quality goals, quality guidelines, furthermore internal iatf 16949 workshops and trainings.
 

RoxaneB

Super Moderator
Super Moderator
#4
If you scroll down to the bottom of this thread you'll see some links to threads where we have discussed similar matters. Or you can try the Search function (blue bar near the top of the screen).

We have had extensive discussions on this matter and you may find something there of help. :D
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
We are thinking of implementing a 90 day review form with a sign off in terms of if the individual is competent or not.
Welcome to The Cove. I recommend you do NOT succumb to implementing such a non-value added solution, which, would only exist to "satisfy" the external auditor lack of comfort.

Who has the biggest interest in assuring the people performing work are competent? The employer does. And, typically, the person's line manager is the best positioned assessor to make such determination. I am sure your organization does not hire anyone, without screening the candidate first, possibly some supervised OJT, some probationary status, etc... until they are "set free" to work. Isn't that part of the process to assess and determine competence?

As for awareness, awareness of what? Depending on what people need to be aware of, different means will be used.

Again, don't create valueless bureaucracy to appease an external auditor...

Good luck.
 

RoxaneB

Super Moderator
Super Moderator
#6
Hello,

We are thinking of implementing a 90 day review form with a sign off in terms of if the individual is competent or not.
Unless you mean an ongoing review, every 90 days for all employees, this approach is only applicable to new employees.

Competency applies to existing employees as well. What if a process changes? What if a document changes? What if the tech changes? What if there is a sudden cluster of complaints or nonconformances in a certain area or attributed to a certain team?

So, to build upon Sidney's point, not only do you want a process that will add value, but you want something that applies to all employees.

How is it currently done? It may be informal/ad-hoc, but I wouldn't be surprised to hear that there is something already in place, and it may simply be a case of either formalizing it, standardizing it, or perhaps tweaking it a bit to make it less bureaucratic.
 

John Broomfield

Staff member
Super Moderator
#7
Hello,

I was wondering if people could share how they are documenting that individuals are competent in their position and also what you are doing in terms of awareness? We had an auditor come and speak with our company and we are weak on these areas. We are thinking of implementing a 90 day review form with a sign off in terms of if the individual is competent or not. Is anyone willing to share what you are doing in these areas? I'm a member of HR and new to this system, however how department is partially responsible for these items. If anyone is willing to give any advice, please reach out.

I'm also new to this board so please let me know if there is a better place for this question.

Thank you!
Af,

Why not run a workshop for your leaders so they can prep their own materials and events to make their employees aware of their quality management system and it’s benefits?

Coming from your leaders the employees may take the QMS a lot more seriously.

Best not to suggest you’re doing this to close out an audit finding.

Have the leaders explain from their more noble reasons why they are doing demonstrating their commitment to their management system.

Make videos and edit them to become part of your orientation package for new staff.

John
 
#8
Hello,

I was wondering if people could share how they are documenting that individuals are competent in their position and also what you are doing in terms of awareness? We had an auditor come and speak with our company and we are weak on these areas.
Before you go rushing off to do anything, what was it you heard that led you to determine a "weakness" in this respect? I'd caution you that "auditors" don't always know the appropriate way to implement this requirement...
 

Mark Meer

Trusted Information Resource
#9
Before you go rushing off to do anything, what was it you heard that led you to determine a "weakness" in this respect? I'd caution you that "auditors" don't always know the appropriate way to implement this requirement...
I agree with AndyN. It'd be helpful to know how the auditor determined that you are "weak on these areas".

Did the auditor interview particular personnel, and find their knowledge lacking? Did they look at your processes documentation, and find that there isn't anything that covers awareness? Were they looking for records that they couldn't find?
 
A

Af7082a

#10
Hi all,

So I wanted to add that this was in regards to the Corporate Office staff. She asked how did we know our staff was competent. We mentioned that we hire them off a job descriptions and if they meet the basic qualifications of the job then we assume that are competent. She think asks how do we know that they are competent in the way we do things and specific technologies we use at our company. We said that the managers train them often using on the job training. If after a couple of months we don't hear from the managers that there are any issues, we consider the team members competent. She stated there should be documentation of that process, so that's where the 90 day review came in to place. We are very good on our manufacturing side, we have work instruction audits and 5 day training plans and evaluations. However currently only salaried team members are evaluated once a year at annual review time. It's more of a no news is good news type of thing when determining if they are competent. So that's the issue that we are trying to adjust. We also had the idea of having each manager write out what they are using for their on the job training and having that on file for each job and then the 90 day review would just document that they were trained on each item as well as they were found competent in performing the tasks. We were going to have a semi annual reviews check ins with salaried team members. I hope this gives a little clarity to the situation.
 
Thread starter Similar threads Forum Replies Date
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
S Amount of Documentation dependent on staff competency Document Control Systems, Procedures, Forms and Templates 15
N Training Competency and Effectiveness Documentation Training - Internal, External, Online and Distance Learning 27
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
H MD Technical Documentation and SALES possibility EU Medical Device Regulations 0
A DMDIV-Variants : definition and technical documentation CE Marking (Conformité Européene) / CB Scheme 4
NDesouza COTS Items CoC for FAI Documentation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
C Documentation hold during submissions? ISO 13485:2016 - Medical Device Quality Management Systems 0
K SOUP (Software of Unknown Provenance) Anomaly Documentation IEC 62304 - Medical Device Software Life Cycle Processes 2
C Gobys for operations documentation plan Oil and Gas Industry Standards and Regulations 4
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Robert Stanley Required Documentation Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 1
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M What is the average time needed for process documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
was named killer CLOUD BASED QUALITY DOCUMENTATION vs. SERVER BASED Document Control Systems, Procedures, Forms and Templates 5
S How to start with ISO process in project based team - Documentation Document Control Systems, Procedures, Forms and Templates 4
K ITAR Visitor Documentation of Citizenship AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Design Verification Documentation ISO 13485:2016 - Medical Device Quality Management Systems 19
A Process Documentation for ISO 9001:2015 Internal Auditing 2
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Good Documentation Practices Self Test? ISO 13485:2016 - Medical Device Quality Management Systems 6
F ISO 17025:2017 mandatory documentation requirements ISO 17025 related Discussions 1
D Virtual Documentation via Master Flow Chart? Process Maps, Process Mapping and Turtle Diagrams 4
S Defining a Quality System from scratch - Preferred system and documentation names Document Control Systems, Procedures, Forms and Templates 4
C Maintenance of Product Technical Documentation EU Medical Device Regulations 3
F PPAP Documentation Control APQP and PPAP 8
V Every good documentation practice observation is an data integrity issue US Food and Drug Administration (FDA) 7
CPhelan Labeling template on QMS - Kitting and labeling documentation Manufacturing and Related Processes 9
DuncanGibbons Documentation aerospace OEMs require with purchase of parts from manufacturers/suppliers Manufacturing and Related Processes 0
V What is the criteria to cite an good documentation practices observation as an data integrity related issue US Food and Drug Administration (FDA) 6
L AS9100 D- Handling Nonconformance Documentation for an organization that outsources most of the work. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
L ISO 9001:2015 standard documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N Time source for paper-based documentation (research nurses) US Food and Drug Administration (FDA) 1
W Documentation - Use of Addendum vs Amendment Document Control Systems, Procedures, Forms and Templates 1
I What level of change in documentation requires re-training? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
D QMS Documentation Process - I want to put all the Process SOPs to a QMS system Document Control Systems, Procedures, Forms and Templates 3
T QMS - Documentation Cloud Storage EU Medical Device Regulations 0
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
B Quality Management System documentation identification Document Control Systems, Procedures, Forms and Templates 11

Similar threads

Top Bottom