How to determine the understanding level of QMS documents?

C

crosu

#1
All laboratory employees involved in testing are expected to read, understand and abide by the spirit of this quality manual in completing their job responsibilities.

How is determined that laboratory employees really understand the content of the quality management system documentation?

Thanks,

Christian Rosu
 
Elsmar Forum Sponsor

Wes Bucey

Quite Involved in Discussions
#2
All laboratory employees involved in testing are expected to read, understand and abide by the spirit of this quality manual in completing their job responsibilities.

How is determined that laboratory employees really understand the content of the quality management system documentation?

Thanks,

Christian Rosu
Pretty much the same way ANY employee is determined to be "competent" - some senior person devises (or has some expert devise) a type of test or questionnaire to validate the person's comprehension of the instructions. Depending on the instruction, the comprehension test can be pen and pencil or a practical exam wherein the person actually performs the process under the watchful eye of a person qualified to pass or fail the performance.

Truth be known, many folks do NOT write easily comprehended instructions - for proof, I refer you to the USA tax code!:lmao: The comprehension test also serves as a check on the validity of the instruction being an adequate instrument for conveying the proper way to perform a process. If too many folks DO NOT pass the comprehension test, the problem may be with the instructions, NOT the persons undergoing the test. (This might be a good time to review Deming's Red Bead experiment!)
 
Last edited:

Stijloor

Staff member
Super Moderator
#3
All laboratory employees involved in testing are expected to read, understand and abide by the spirit of this quality manual in completing their job responsibilities.

How is determined that laboratory employees really understand the content of the quality management system documentation?

Thanks,

Christian Rosu
One should start by evaluating the readability of the QMS documentation.
Too many times, the documents are written at a level and complexity that makes it very difficult to comprehend.

I did a search on Google on: "Test for readability." Interesting stuff pops up.

Really, begin there...then worry about comprehension on part of laboratory personnel.

Stijloor.
 
#4
All laboratory employees involved in testing are expected to read, understand and abide by the spirit of this quality manual in completing their job responsibilities.

How is determined that laboratory employees really understand the content of the quality management system documentation?

Thanks,

Christian Rosu
Er.......internal audits, perhaps?
 

BradM

Staff member
Admin
#5
All laboratory employees involved in testing are expected to read, understand and abide by the spirit of this quality manual in completing their job responsibilities.

How is determined that laboratory employees really understand the content of the quality management system documentation?

Thanks,

Christian Rosu

Hello there, Christian!:bigwave: Welcome to the Cove!:)

To a fundamental level, any employees within any QMS (Quality Management System) should demonstrate an understanding of the manual.

The older I get, the more cynical and questionable I become.:tg: I don't think it's any form of rebellion, per se, but rather a true desire to understand. Why do you do that? Why is it that way? For if I have that answer, your request seems to be much more plausible to me. With me, so should the quality policy. It should be able to answer some questions as to why we are all messing with the QMS in the first place.

As far as measuring understanding:

1. Ask them
2. Observe them
3. Test them

If you want them to know something, first make it worth something to know. Make it relevant to them and their job, and give them some sense that they can make a difference within that policy.
 
Thread starter Similar threads Forum Replies Date
L How to determine / validate Medical Device Storage Conditions ISO 13485:2016 - Medical Device Quality Management Systems 1
John C. Abnet ISO 9001 4.4.1 "...shall determine the processes needed..." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 72
S Is using ANSI/ASQ Z1.4-2008 the correct sampling plan to determine Pass/Fail of Apparel measurements? AQL - Acceptable Quality Level 4
E How do you determine if hipot is necessary for a cable product? Manufacturing and Related Processes 8
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
M Measurement Error - How to determine what is acceptable? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
S How to determine & document Organizational Knowledge of a company Document Control Systems, Procedures, Forms and Templates 4
O Monitoring performance - How do I determine performance measurement basis within my organization? Misc. Quality Assurance and Business Systems Related Topics 4
T IEC 60601-1 - Risk assessment to determine the liquid - 11.6.3 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
Ashok sunder How to determine the internal and external issues in ISO 45001 standard? Occupational Health & Safety Management Standards 2
C ICP versus AA: How to determine appropriate specification for assay method verification Qualification and Validation (including 21 CFR Part 11) 1
samer Do we have to determine Educational level for all Staff as pr 7.2 b clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Calibration of Pressure Gauge, How to Determine Calibration Tolerance General Measurement Device and Calibration Topics 1
S Supplier Qualification - How do we determine which suppliers to qualify? ISO 13485:2016 - Medical Device Quality Management Systems 9
K ISO 13485:2016 Cl. 4.2.3 - Determine QMS Processes, Monitoring, Measuring, etc. ISO 13485:2016 - Medical Device Quality Management Systems 4
A Compliance Obligations - Implementing 6.1.1 and 6.1.3 NOTE - Determine risks and... ISO 14001:2015 Specific Discussions 1
B Auditing Senior Management to determine the Effectiveness of Management Processes IATF 16949 - Automotive Quality Systems Standard 6
R What testing would you run to determine if a device is "Clean"? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B Maximum Material Condition with Bonus - Determine Cpk for this one kpc Measurement Uncertainty (MU) 2
Q Tissue Adherence Test to determine how Tissue sticks to Gauze Other US Medical Device Regulations 2
C DOE - How to determine optimal settings and transposing data Statistical Analysis Tools, Techniques and SPC 2
insect warfare Cannot determine what type of medical device this product is.... 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Buckyb Are KPIs a requirement to determine Process Effectiveness? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
M Is a Real Time Stability Study required to determine Expiration Date? EU Medical Device Regulations 9
K How to determine rated input power for the markings? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
I How to determine the thread wire size needed - Buttress Thread Gauge General Measurement Device and Calibration Topics 3
M How to determine Process Capability using Minitab 17 Capability, Accuracy and Stability - Processes, Machines, etc. 6
V How does ASQ determine Exam Cutoff Marks Professional Certifications and Degrees 2
R How to Determine Working Voltage & Tolerance for Isolation Barriers? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
apestate How to determine all regulatory and statutory requirements to be met? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Gage R&R Study (Crossed) - How to determine Process Tolerance Using Minitab Software 4
D How can I determine a process metrics? Manufacturing and Related Processes 1
D Can I use the % Tolerance to determine the actual process tolerance? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
R How to determine the Thickness tolerance of the Cold Rolled Steel Manufacturing and Related Processes 6
T Technical regulations that determine the acceptable limits of cigarettes General Measurement Device and Calibration Topics 4
J How does Layout Inspection determine Reference Value? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
Q PPAP - How to determine the "Design Record Change Level" APQP and PPAP 2
K 7.6 c) c) Have Identification in order to determine Calibration Status Calibration Frequency (Interval) 3
S How to determine part that is most difficult to sterilize Other Medical Device Related Standards 10
G How to determine if a Standard is Auditable General Auditing Discussions 15
L Who and when to determine AQL for our product inspection AQL - Acceptable Quality Level 1
R 4 Factors 3 Level DOE to determine which factors are significant Using Minitab Software 2
C How to determine a sample size for comparison purposes ? Quality Tools, Improvement and Analysis 2
S How to determine Preventive Maintenance and Calibration Grace Periods General Measurement Device and Calibration Topics 4
J How to determine a Capability Study for Low-Volume Suppliers Capability, Accuracy and Stability - Processes, Machines, etc. 3
C Statistics equation to determine the number of samples in a lot Statistical Analysis Tools, Techniques and SPC 8
S How to determine the Air Clearance for Floated Secondary Circuit IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
somashekar How to Determine the Necessary Employee Competence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F ISO 22000 Clause 7.4.4 to determine whether a control is a CCP or and OPRP Food Safety - ISO 22000, HACCP (21 CFR 120) 2
D Best Minitab Tool to determine a Statistically Significant Trend Using Minitab Software 5

Similar threads

Top Bottom