Making everyone follow documentation (document control) policies

G

global citizen

#1
Have you ever had experience with the following? Some personnel…

1. do not sign quality assurance paperwork.
2. leave some blanks on the paperwork.
3. do not follow the proper error correction procedure.
4. uses colored pens & white-outs even though it is against our contract with our customer
5. submit incomplete paperwork.

What do you do? :confused:
 
Elsmar Forum Sponsor

Wes Bucey

Quite Involved in Discussions
#2
Re: Making everyone follow documentation policies

Have you ever had experience with the following? Some personnel…

1.do not sign quality assurance paperwork.
2.leave some blanks on the paperwork.
3.do not follow the proper error correction procedure.
4.uses colored pens & white-outs even though it is against our contract with our customer
5.submit incomplete paperwork.

What do you do? :confused:
You talk to them and find out WHY?

Added in edit - the point is we are not police and executioners; we are fact finders who offer solutions once a problem is defined.
 
Last edited:
G

global citizen

#3
Re: Making everyone follow documentation policies

Yea, well, these policies are included in their QA Training before they even start their job. There was even a time when I sent out memos to people who don't follow them. As to the why: they just don't feel like it, I suppose, because there are no consequences.

Finding: Documentation policies are not being followed.

Solution: Should we start firing people? :D
 

Helmut Jilling

Auditor / Consultant
#4
Re: Making everyone follow documentation policies

Yea, well, these policies are included in their QA Training before they even start their job. There was even a time when I sent out memos to people who don't follow them. As to the why: they just don't feel like it, I suppose, because there are no consequences.

Finding: Documentation policies are not being followed.

Solution: Should we start firing people? :D
Take one out behind the building and shoot him...after that, the rest will begin to follow...;)


Actually, no, that went out with King Louie the 14...

Try to make the requirements as simple and clear and easy as you can. It helps if top management supports you.
 
Last edited:
G

global citizen

#5
Re: Making everyone follow documentation policies

Take one out behind the people and shoot him...after that, the rest will begin to follow...;)


Actually, no, that went out with King Louie the 14...

Try to make the requirements as simple and clear and easy as you can. It helps if top management supports you.

Yes, thanks. We will have a meeting again next week and I am going to raise this in front of everyone, including the CEO and CFO and see what they say while I am thinking of a 'solution'. :D
 
G

Geoff Withnell

#6
Don't ship until the paperwork is complete and correct! Amazing how fast things get done correctly then!

Geoff Withnell :)
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#8
Re: Making everyone follow documentation policies

Yea, well, these policies are included in their QA Training before they even start their job. There was even a time when I sent out memos to people who don't follow them. As to the why: they just don't feel like it, I suppose, because there are no consequences.

Finding: Documentation policies are not being followed.

Solution: Should we start firing people? :D
I would look at the training program. Is the point getting across to the employees. Maybe the instructor needs education/training.

Recommendation: Do a 5 Why's Analysis on the issue and determine the true root cause.
 

SteelMaiden

Super Moderator
Super Moderator
#9
Citizen

Where do you stand in the organization? Do you have the responsibility to ensure that all are doing what the company's documentation says (policing)? Do you have the authority to do something about it (disciplining)?

People do not do things (or not do things) just because they feel like it, or not feel like it. I am getting the feeling that people are not following the requirements because perhaps the requirements are not necessarily helpful? example: If that many people are not filling out some portion of a form, are you sure that you need the information? If one person is filling out the entire form, do you need to have them sign each and every line of the form?

I think that it is time for someone to go through your procedures and work instructions and figure out exactly what people NEED to do, instead of what you want them to do. These are the folks who are "doing" every day. Let them have a say in what and how it is to be done. You cannot sit in your office and write work instructions for people to follow if you do not have the experience of the job to back you up.:2cents: Empower your employees, in the end, it is those folks who are not completing the fors who will make or break your efforts to be certified, not the person controlling the documents. Besides that, it is much more pleasant to work as a team than it is for someone to play ISO Cop and hand out beatings.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#10
Citizen

Where do you stand in the organization? Do you have the responsibility to ensure that all are doing what the company's documentation says (policing)? Do you have the authority to do something about it (disciplining)?

People do not do things (or not do things) just because they feel like it, or not feel like it. I am getting the feeling that people are not following the requirements because perhaps the requirements are not necessarily helpful? example: If that many people are not filling out some portion of a form, are you sure that you need the information? If one person is filling out the entire form, do you need to have them sign each and every line of the form?

I think that it is time for someone to go through your procedures and work instructions and figure out exactly what people NEED to do, instead of what you want them to do. These are the folks who are "doing" every day. Let them have a say in what and how it is to be done. You cannot sit in your office and write work instructions for people to follow if you do not have the experience of the job to back you up.:2cents: Empower your employees, in the end, it is those folks who are not completing the forms who will make or break your efforts to be certified, not the person controlling the documents. Besides that, it is much more pleasant to work as a team than it is for someone to play ISO Cop and hand out beatings.
Valid points everyone of them, Steel.
 
Thread starter Similar threads Forum Replies Date
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Steve Prevette Informational I am presenting a webinar Thursday - "Data Driven Decision Making" - 19 November 2020 Statistical Analysis Tools, Techniques and SPC 5
J Masters Degree - Advice about a decision I"m going to be making Career and Occupation Discussions 9
U What is the process for making updates to our Processes? Design and Development of Products and Processes 11
M Informational US FDA Final Guidance – Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classificati Medical Device and FDA Regulations and Standards News 0
K Verifying gas tight glass syringe used for making standards General Measurement Device and Calibration Topics 4
M Informational US FDA – Patient-Reported Outcomes (PROs) in Medical Device Decision Making Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Patient Preference Information (PPI) in Medical Device Decision-Making Medical Device and FDA Regulations and Standards News 0
U Electronic templates for making paper control charts Reliability Analysis - Predictions, Testing and Standards 2
K Turtle diagram or process interaction chart - Making it easier for an auditor Process Maps, Process Mapping and Turtle Diagrams 23
E CSR SHIPPING - Need suggestions for making SOP/WI for our shipping dept (automotive)... Customer and Company Specific Requirements 11
O Reinstating a disqualified supplier—questions to ask before making a decision Supplier Quality Assurance and other Supplier Issues 2
D Controlled Documents & Note Making ISO 13485:2016 - Medical Device Quality Management Systems 4
I Making a process PFMEA, no DFMEA (non-automotive toll manufacturer) FMEA and Control Plans 1
M IATF 16949 Cl. 8.7.1.4 - Risk analysis for decision making about rework IATF 16949 - Automotive Quality Systems Standard 2
D Help needed for Compliance Road-Map - Startup making their first device (IVD) IEC 62304 - Medical Device Software Life Cycle Processes 1
C IATF 16949 Cl. 8.4.1.2 d) Multidisciplinary Decision Making IATF 16949 - Automotive Quality Systems Standard 2
G Is it compulsory to make DFMEA for proto parts making organisation APQP and PPAP 1
L Making a Medical Devices Registration Database - Help and Suggestions Wanted Other Medical Device and Orthopedic Related Topics 2
B Making a Safety Culture Chart Occupational Health & Safety Management Standards 3
Marc ISO 9001:2015 vs. 2008 - Internal Audits - What changes are you making? Internal Auditing 44
4 Customer Making Changes to a 510k Device They Purchased 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Making a change to an approved Medical Device Other US Medical Device Regulations 9
M Making Amendments to a Quality Manual Quality Management System (QMS) Manuals 2
V Making a choice of Simple vs Comprehensiveness of Procedure/System of any Process Document Control Systems, Procedures, Forms and Templates 4
K Making a Quality Requirements Handbook for Employees Training - Internal, External, Online and Distance Learning 10
D ROHS 2 - Medical Device: Placing vs Making Available on the market EU Medical Device Regulations 3
J Keyboard issue in Word - Making me nuts Coffee Break and Water Cooler Discussions 5
W Chinese Distributor Making Counterfeit Products - Class I sterile products China Medical Device Regulations 2
P Making Quality and Compliance Invisible Imported Legacy Blogs 0
AnaMariaVR2 Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
Proud Liberal Making a simple Sampling Plan by Variables Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
N Decision Making... (joke) Funny Stuff - Jokes and Humour 1
G The right approach for making the transition from ISO9001 to AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M AS 9100 4.2.4 Process for making changes to records is not fully effective Quality Manager and Management Related Issues 4
V Making Solar cells, Module, String - Which Cleanroom Level? Various Other Specifications, Standards, and related Requirements 2
P Outsourced Manufacturing - Making Subcontractors comply with TL9000 TL 9000 Telecommunications Standard and QuEST 2
G Free ASTM Standards? Recent Court Ruling making their standards free? Various Other Specifications, Standards, and related Requirements 10
U ISO 13485 mandatory for a factory making Medical Devices for EU? EU Medical Device Regulations 6
B Categorization of Customer Complaint: Making Customers feel they are Top Priority Customer Complaints 4
E Starting Nadcap Accreditation and making an Implementation Timeline AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C Making a Box Plot in Excel Excel .xls Spreadsheet Templates and Tools 3
V Ideas, Measures/Metrics for making Quality Proactive? US Food and Drug Administration (FDA) 2
D 3D Printers - Making Replicas Coffee Break and Water Cooler Discussions 11
E Third party auditor's statement about SPC - Steel Making - EAF Statistical Analysis Tools, Techniques and SPC 11
K Seeking help in making a decision - Project behind schedule Quality Manager and Management Related Issues 11
Q Making a Dashboard for the KPI of our department Misc. Quality Assurance and Business Systems Related Topics 2
F Making a REACH statement - Plastic Injection Moulding RoHS, REACH, ELV, IMDS and Restricted Substances 9
W What are the Rules for making Organograms? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
AnaMariaVR2 Office Prank - Making an Office Disappear Funny Stuff - Jokes and Humour 0

Similar threads

Top Bottom