Operator process buy-in - how to get it?

Fender1

Involved In Discussions
#1
I’m a quality coordinator for a custom welding/fabrication company. We have been trying to develop/improve our quality system for the past few years. Company size is 70-100 employees. Ownership’s target isn’t ISO cert, but they do want a sound system. We produce hundreds of different products weekly per drawings by various customers; we are not design responsible. Our largest and longest history customer expect us to save their drawings at our site and they are sometimes slow to provide drawing updates, and yes, it has caused shipments of wrong part version. Typically our other customers are good at providing latest product info/drawings with each quote request or purchase order. We don’t ship a lot of NC; most NC that does ship is typically due to failure to complete process.

Almost all of the products we provide is operator set/created/intensive (persistent opportunity for operator error,) so results of each production process are to be verified by an approved person (typically supervisor or lead-person,) before product release to next process. All of our production process results are to be checked by 2-set of eyes.

This company doesn’t have a history of firm discipline for not complying with process/policies, and some (typically veterans,) staff in production doesn’t believe stated verification of their work is needed, so they often allow product forwarding without planned verification. When discussed, the veterans state that they “know what they’re doing, don’t need their work checked”; even when shown that they are producer of a product NC. To date, process changes we’ve deployed to stop forwarding of non-verified work, haven’t been robust enough to ensure proper verification. Supervisors haven’t been helpful, very little promoting or monitoring.

I believe, to continue improving our quality system, company needs to be stronger on procedure/police enforcement. I like a challenge, but further system improve looks dire from where I sit. As enforcement is out of my control, I’m hoping that someone in the Cove community has experienced a similar scenario and will provide suggestions for us to consider. Something to help operator buy-in. I’m not yet ready to give up.

I truly appreciate the Elsmar Cove resource. For inexperienced folks like me… pure gold!
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
From what I understand, what your organization really needs is a CULTURAL shift. A culture that allows lack of discipline and pride in workmanship is a huge problem.

That is obviously something that, until leadership management agrees need to be changed, very little you can do, in order to change.

One suggestion I have is: for those instances where the nonconforming product reached the outside customer and the product returns, involve the operator, make him a customer-facing participant explaining to the customer why he delivered something that was wrong. That might instill sense of ownership of quality into some of them and trigger a change.

When they say they don't want to have their products checked by someone else, they should be able to stand by the quality of their products and face the customers, then.

Good luck.
 
Last edited:

Golfman25

Trusted Information Resource
#3
I see a conflict in your posting. First you say you don't ship a lot of NC. Then you say you're having issues with "independent" verification of the work. So is the verification really a problem if apparently most of the time the product is good? What's the risk?

Seems to me they want to be treated like adults or they have attitude problems. If it's attitude, then all you can do is deal with it or get rid of them. Otherwise, treat them like grownups. The "cops and robbers" game doesn't work.

So how can you ensure conformance to specs. without supervisor verification? Can't they check their own work and sign off on it? Maybe teams, instead of supervisors? Sometimes a second set of eyes is good, but it doesn't have to be a "boss." Get creative.
 

Stijloor

Staff member
Super Moderator
#4
Here is some good stuff from our distinguished Cove Members for reading & studying about Employee Motivation and Complying with the QMS.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#5
From what I understand, what your organization really needs is a CULTURAL shift. A culture that allows lack of discipline and pride in workmanship is a huge problem.

That is obviously something that, until leadership management agrees need to be changed, very little you can do, in order to change.
Ditto what Sidney said. This is, first and foremost, a cultural issue and who is responsible for the culture? Leadership. Top Management. Unless/until Top Management gets into this, you are fighting a never-ending battle. Good luck.
 

Golfman25

Trusted Information Resource
#6
I disagree a little bit. Sometimes people with good intentions come up with unrealistic ideas which cause conflict. Back in the day when we started calibration our quality guy insisted that tool maker personal equipment be calibrated. Problem is he insisted that the quality people do it. The toolmakers didn't want anyone touching their "stuff." There was a constant battle until I stepped it and said there is nothing which says they can't calibrate their own stiff. So quality gives them the list and says return it in a week.

In the OP it might just be that the welders feel disrespected.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#7
Allegedly these welders are claiming they and their work are above review ("above the law") even when shown they are producing NC work that is reaching a customer. In such case maybe they deserve feeling some disrespect.

Our welder invites people to look over his work, because he wants others to see how good his work is. But in his case, I have found it to be a waste of time -- he can find a flaw in his work long before any of our inspectors can, and he "rats" on himself in such cases -- a consummate professional. It does not sound like the OP's welders are the same. JMO.
 
Thread starter Similar threads Forum Replies Date
somashekar Adding an other process into the system - Authorised Economic Operator (AEO) Scheme ISO 13485:2016 - Medical Device Quality Management Systems 4
M PFMEA (Process FMEA - Potential Causes and Failure) - Operator's Role FMEA and Control Plans 11
R Process Qualification, Equipment Qualification, Operator Qualification - Sequence? Manufacturing and Related Processes 10
L 4.9.1 Process Monitoring & Operator Instructions QS-9000 - American Automotive Manufacturers Standard 1
M Nonconforming parts accepted by operator with intention Human Factors and Ergonomics in Engineering 31
H EU MDR Economic Operator notifications? EU Medical Device Regulations 1
M Inter-operator Variability Testing - Requirements for EU Medical Device Regulations 5
B Operator protection - When to apply table 7, Dielectric strength test voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
P Economic operator responsibilities - when the Importer is also Distributor - Article 13 EU Medical Device Regulations 1
P How far an operator can reach into a machine before it becomes an ergonomic problem CE Marking (Conformité Européene) / CB Scheme 5
F Operator Manual and Type B Uncertainty Measurement Uncertainty (MU) 3
R Operator's manuals as prevention design control FMEA and Control Plans 2
M Informational EU – M2M Data Exchange available services for accessing MDR EUDAMED data available for Economic Operator (EO) organisations Medical Device and FDA Regulations and Standards News 0
G 3 Operator Std. Dev. and uncertainty calculation Measurement Uncertainty (MU) 2
T Root causes - operator's actions Problem Solving, Root Cause Fault and Failure Analysis 17
K Article 23 (Parts and components) - Economic Operator EU Medical Device Regulations 1
shrutisancheti EU User manual / operator manual / service manual guidance document(s) CE Marking (Conformité Européene) / CB Scheme 2
GoSpeedRacer How to handle operator involvement in the non conformance ISO 13485:2016 - Medical Device Quality Management Systems 5
K Operator Checks - How to show that they were completed on a checklist as acceptable IATF 16949 - Automotive Quality Systems Standard 2
C ISO 9001:2015 - Non Applicable Design and Development (Power Plant Operator) Design and Development of Products and Processes 2
A Failure Mode from Operator "Components Fallen but Loaded" FMEA and Control Plans 3
A 21CFR807.25 (d) Owner-Operator Contact question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
U USB Connector Operator Protection (MOPP) IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
L Warning Letter adressed to owner/operator or facility? US Food and Drug Administration (FDA) 1
B How to change the FDA Device Registration and Listing Module - Owner/Operator Other US Medical Device Regulations 10
M Template for Quality Awareness Training to all Operator Document Control Systems, Procedures, Forms and Templates 6
P Countermeasure For CMM Operator Error Problem Solving, Root Cause Fault and Failure Analysis 4
I Operator Initialling on Paperwork - FDA Good Documentation Practices Other US Medical Device Regulations 11
M Can I continue using IEC60601-1 Ed2 PSU for MOOP (Means Of Operator Protection) IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Mr.Happy Operator Mistakes (Errors) and responding to CAR (Corrective Action Requests) Nonconformance and Corrective Action 20
K Poka Yoke for Leaf Spring placement by Operator Misc. Quality Assurance and Business Systems Related Topics 2
D Nonconformance or Misinterpretation - When an operator does a Nonconformance Report Nonconformance and Corrective Action 31
shimonv Operator vs. Manufacturer Relationship and ISO 13485 / CE Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
D If a control operator add a photo as a visual aid, can you improve Occurrence? FMEA and Control Plans 12
C Operator Forgot to Follow Procedure - Now What? Manufacturing and Related Processes 6
L GB15980-2003 Bioburden Count Trend on Operator Hands Other ISO and International Standards and European Regulations 1
L Decision Matrix to help Operator driven Continuous Improvement Lean in Manufacturing and Service Industries 3
I Corrective Action Reply to a Customer - Operator Error Nonconformance and Corrective Action 50
M Voluntary Action by Human Operator Influences Availability? Reliability Analysis - Predictions, Testing and Standards 2
J Standardized Operator Work Practices - Work Instructions - To what Level ? Manufacturing and Related Processes 8
optomist1 Nested Gage R & R One Operator One Sided Spec Using Minitab Software 5
C Corrective Action and Preventive Action for Operator Error (Cosmetic - Handling) Preventive Action and Continuous Improvement 15
optomist1 MSA Gage R&R - Destructive Test with One Sided Specification and One Operator Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
S SPC Gap Analysis for Operator Training Needs Training - Internal, External, Online and Distance Learning 6
C Authorised Economic Operator Status (EU) - HMRC (Her Majesty's Revenue and Customs) Other ISO and International Standards and European Regulations 6
M Operator/Patient Leakage Current IEC 60601 - Battery Charger IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Q Adding Malicious Operator to FMEA? Quality Manager and Management Related Issues 12
S Control Plan Details vs. Operator Instruction Sheets - Document Contents IATF 16949 - Automotive Quality Systems Standard 9
P ERP (Emergency Response Plan) for Small Air Operator EASA and JAA Aviation Standards and Requirements 7
S Operator Error - How to do a Corrective Action Nonconformance and Corrective Action 14

Similar threads

Top Bottom