Errors & Omissions in Creating QMS Procedures

Elsmar Forum Sponsor

Jim Wynne

Leader
Admin
#3
In addition to Randy's advice, being an SME is not necessarily a good indication that a person is competent in writing QMS documentation, but it's the place to start. Someone who understands the processes involved needs to at least review the documents before they're released.
 

John Broomfield

Leader
Super Moderator
#4
Is there a best practice to ensure managers do not leave out important steps when creating QMS procedures?
The process owner (not necessarily a supervisor or manager) engages members of the process team in reviewing their documented procedure for as-is accuracy. That way the procedures are not created as works of fiction.

Procedures for newly designed processes are accurately documented to the extent necessary for their effectiveness in planning, training and operation. But always be ready to make any required changes.
 

ChrisM

Quite Involved in Discussions
#5
Is there a best practice to ensure managers do not leave out important steps when creating QMS procedures?
Yes, review by a SME. This applies not just to QMS procedures but any "official" procedure (or instruction) written by anybody for any purpose. Always have it independently reviewed because the more you are familiar with the "process", the more likely you are to leave something out when documenting it due to over-familiarity. It's one reason why it is recommended that product instructions should be written by a "non-technically competent" person
 

John Predmore

Trusted Information Resource
#6
I agree someone knowledgeable should write down the steps of the procedure as well as inputs, outputs, criteria for acceptance, and any caveats. Maybe someone else formats and edits for readability.

Many times, the real value of a procedure is to train a new person, or guide a person who does not perform the procedure very often (perhaps a fill-in substitute in the case of vacation or other absence). If that is how the procedure will be used, a best practice would be to select such a person, knowledgeable but otherwise uninvolved in writing the procedure, who then attempts to follow the about-to-be-released procedure in a simulated or real life scenario.
 

Zero_yield

"You can observe a lot by just watching."
#7
People have talked about several piece of this, but the best procedures generally have the input from:

-At least one technical expert on the process. Someone who knows why the process works.
-At least one hands-on expert on the process. Someone who knows the nuts and bolts of how the process actually works in practice.
-At least one compliance / quality person. Someone who knows what the regulations say about how the process is supposed to be done and/or is familiar with the problems that often crop up from the process.
-At least one person familiar with the process as a whole. Someone who understands why the inputs are the way they are and what processes are depending on the outputs from the operation.
-At least one person good at writing human-readable procedures.

One person can potentially cover multiple of the above.

Definitely agree with the suggestions above to try training someone who doesn't currently understand the process using the WIP procedure.

And of course, the last pieces are continuous improvement + deviation management. No one ever gets it perfect the first time. Even if you do magically write the perfect procedure, you'll eventually need to change it. Keep making corrections and clarifications as you find issues with current procedures.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#8
You know how employees mark notes on official QMS SOPs? This is frustrating but its also a source of improvement. If you find a marked-up SOP in production with notes on it about the procedure, use those notes to release a new procedure if they are factually correct -verify with author.
 

Zero_yield

"You can observe a lot by just watching."
#9
You know how employees mark notes on official QMS SOPs? This is frustrating but its also a source of improvement. If you find a marked-up SOP in production with notes on it about the procedure, use those notes to release a new procedure if they are factually correct -verify with author.
And if they're hiding their marked-up ones too well, take them off the floor, give them a copy of the current procedure, a red pen, and some time, and let them go to town.
 
Thread starter Similar threads Forum Replies Date
T Use errors identification - based on primary operating functions or use scenarios ? IEC 62366 - Medical Device Usability Engineering 3
H Machine Malfunction & Operator Errors Human Factors and Ergonomics in Engineering 14
C Random defects vs systematic (designed in) errors or faults. Design and Development of Products and Processes 1
NDesouza Getting Rid of Part Marking Errors Benchmarking 40
V Sequence of performing risk assessment: User_FMEA (User Errors) vs Design Inputs FMEA and Control Plans 1
M User Errors and Product Nonconformances Nonconformance and Corrective Action 22
C Flatness Measurement Errors from a Datum - Test Method General Measurement Device and Calibration Topics 3
R Common Statistical Errors Using Minitab Software 1
C Raising NCRs for Supplier Errors Supplier Quality Assurance and other Supplier Issues 10
C Customer Documentation Errors when completing an AS9102 FAIR AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
2 High-tech medical equipment to reduce medication errors Medical Information Technology, Medical Software and Health Informatics 5
K Root Cause of Documentation Errors Problem Solving, Root Cause Fault and Failure Analysis 11
J Training Records for Errors (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P Which test to use in Minitab to determine difference in Number of Errors per Day Using Minitab Software 1
B Propagation of Errors in Calculations - Thickness of a coating material inside a tube Using Minitab Software 6
M Operator Mistakes (Errors) and responding to CAR (Corrective Action Requests) Nonconformance and Corrective Action 20
B Documentation Errors - Documentation that accompanies our Component Products Nonconformance and Corrective Action 8
V Common Errors while Implementing Risk Management Process ISO 14971 - Medical Device Risk Management 9
H Spelling Errors in User Manual (IFU) for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 13
D How to compute the Permissible Errors for Class 2 Weighing Scale General Measurement Device and Calibration Topics 2
Wes Bucey Disturbing news - No decline in medical errors World News 11
E ASTM E2309-05 Classification Table - Fixed to Relative Errors General Measurement Device and Calibration Topics 5
S Typographical Errors in QC Records Nonconformance and Corrective Action 9
M Does Disciplinary Action Reduce Operator Errors? Misc. Quality Assurance and Business Systems Related Topics 80
A Width and location errors in MSA (Measurement System Analysis) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
Jen Kirley In the news: Checklist said to save lives and $ in medical errors World News 5
H How to correct typographical errors on IPC Certificates? Training - Internal, External, Online and Distance Learning 3
P Eliminating Systemic Errors in the Labeling Process Manufacturing and Related Processes 21
Q Errors in the AIAG's SPC manual? Need help reviewing charts. Statistical Analysis Tools, Techniques and SPC 8
S Relationship of errors with respect to measurement results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
Q Shipping Efficiency - 1% return rate due to shipping errors Misc. Quality Assurance and Business Systems Related Topics 6
A Medical Errors prevention simulators World News 2
J Packaging Errors - quantity, missing components Manufacturing and Related Processes 15
A Training Video on Pharmaceutical CAPA and Uncorrected Errors Training - Internal, External, Online and Distance Learning 5
L Categories for data collection - Designing a form for when errors occur Nonconformance and Corrective Action 6
C Software Calculation Errors for Cp and Cpk With Unilateral Tolerances Capability, Accuracy and Stability - Processes, Machines, etc. 4
J Dimensional Layout Errors Registered Visitor Articles Archive 4
J How do I calculate the percentage of errors, when I know min, max, mean, cp and CPK Capability, Accuracy and Stability - Processes, Machines, etc. 3
Marc Errors - Uncertainty Type I, II, or Alpha, Beta vs. Gage R&R Measurement Uncertainty (MU) 1
S Mistake Proofing: human paperwork errors Misc. Quality Assurance and Business Systems Related Topics 8
C Permissible ISO 9001 Exclusions/Omissions for the Service Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S Creating a Quality culture! AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Y Creating Equipment qualification protocol Qualification and Validation (including 21 CFR Part 11) 2
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
L Hazardous Waste - Tips for creating standardized training Miscellaneous Environmental Standards and EMS Related Discussions 2
M Informational Creating a post market surveillance (PMS) system for medical devices – Part 1 Medical Device and FDA Regulations and Standards News 7
J Sample size for creating a data base as a reference to a tested variable Other Medical Device and Orthopedic Related Topics 6
8 Creating Flow and Pull Game Lean in Manufacturing and Service Industries 6
B Main responsibility for Control Plans - creating and maintaining FMEA and Control Plans 15
shimonv Creating a new commercial product based on a modification to an existing product Other US Medical Device Regulations 4

Similar threads

Top Bottom