Production duties vs. Final Acceptance Testing - New Quality Manager needs HELP!!!

Elsmar Forum Sponsor

Cari Spears

Super Moderator
Staff member
Super Moderator
#12
Hi MsHeeler - haven't seen you around in a while - it's good to see you back.:bigwave:

MsHeeler said:
We make optical devices and most of the final inspection is visual. I just don't see how that can be ok.
Why not? Do you have a lot of customer rejections? Is nonconforming product being approved and shipped?
 

CarolX

Super Moderator
Super Moderator
#13
MsHeeler said:
Then why have a quality department, production could do final acceptance test on their own work?
Good question -

Production should do final acceptance test on their own work. How else do they know if they are making good parts?

My personal goal has always been the elimination of the Quality Department. Why? Because we add no value to the product. The Quality Department doesn't make anything, they have no control over how parts are made (doens't mean we don't have input).

At my company, set-up personell are responsible for product quality. The QC department just serves as a ""second set of eyes". We don't approve set-ups to run, we don't ok out of tolerance conditions. Final inspection is a review of all previous operations. QC doesn't make a thing, so how can we be responsible for it?


MsHeeler said:
I forgot to mention that I am a certified auditor and he has no training at all!
No training at all in what? Did they just pick the warmest body to fill the slot? Don't get me wrong...this isn't a bash, but what does being a certified lead auditor have to do with this situation?
 
M

MsHeeler

#14
My problem with this is that when you have been working on an assembly for 2 days, you may tend to overlook something that you would have seen otherwise. There will be no checks and balances.

How many times have you been working on something and think you have it just right and someone else looks at it a immediatly notices a problem that is as plain as day???

Yes a production worker can check his own work, and sign off on his own work, but not sign off for final acceptance. This is wrong! :whip:
 
M

MsHeeler

#15
No training at all in what? Did they just pick the warmest body to fill the slot? Don't get me wrong...this isn't a bash, but what does being a certified lead auditor have to do with this situation?
They made the production manager the quality manager, we are ISO Certified and he had never even read the standard. We have an outside auditor coming in next month and there are obvious problems that he refuses to fix.

For instance, the procedure says that EDS parts will be labeled, we have never done this and we don't even have any labels.... problem, he says it's ok. :eek:
 
Last edited by a moderator:
M

MsHeeler

#16
I was the ISO Coordinator at the last place I worked, I am the Warehouse Manager here.

Hi Cari, I didn't think I would need to be back, but now...... I knew I might find some help here.

Yes we have had NC products shipped. We just got a bad report, and our parent company is wanting to come and inspect our line. This is a very technical assembly. Most of the items are small electrical parts that have to be put together exactly right.

The quality inspectors (well one out of two of them) is the problem. When an inspector can do final testing and pass a unit, and then turn right around and do QA testing on the same part and fail it.... I could say so much more......! Like SHE IS THE QUALITY MANAGERS GIRLFRIEND!!! :mad:

MsHeeler
 
Last edited by a moderator:

Wes Bucey

Quite Involved in Discussions
#17
MsHeeler said:
My problem with this is that when you have been working on an assembly for 2 days, you may tend to overlook something that you would have seen otherwise. There will be no checks and balances.

How many times have you been working on something and think you have it just right and someone else looks at it a immediatly notices a problem that is as plain as day???

Yes a production worker can check his own work, and sign off on his own work, but not sign off for final acceptance. This is wrong! :whip:
I, too, ran a shop where primary responsibility of Quality Department was to negotiate and set quality criteria, including instrumentation and training in same, for operators to do their own inspection. Quality guys settled questions. They did not raise questions. Regardless if question arose at customer or in-house, Quality guys spearheaded the research to determine the truth and find a fix, not a goat to blame.

I agree that a non-systematic inspection can miss stuff. That is precisely the reason for an inspection checklist and the purpose for "mis en place" (having everything at hand for performing the required inspection - prints, instruments, instructions, etc.)

There is a place for "redundant inspection." That is on First Article Inspection, which may include "laboratory grade" instrumentation versus shop instrumentation. The FAI records EVERY characteristic, which is not usually the case in in-process and final inspections.
 
#18
MsHeeler said:
I am the Warehouse Manager here.
MsHeeler
Does the product come to you after final production inspection, if so you can do an incoming warehouse inspection to catch the NC's and issue him the actions!;)
 

Helmut Jilling

Auditor / Consultant
#19
MsHeeler said:
My problem with this is that when you have been working on an assembly for 2 days, you may tend to overlook something that you would have seen otherwise. There will be no checks and balances.

How many times have you been working on something and think you have it just right and someone else looks at it a immediatly notices a problem that is as plain as day???

Yes a production worker can check his own work, and sign off on his own work, but not sign off for final acceptance. This is wrong! :whip:

You make valid points, for your scenario. Other posters also made valid points, from their types of companies. The obvious inference is different cultures, products, testing requirements, different situations would require different answers. There is no one answer to these types of questions.

I have seen many situations where operators inspect their own work. Others, have a quality person spot verifying things are being done well. Others have quality inspect everything.

Different situations benefit from different results. Don't define the method, define the desired output and build a process to achieve that output.
 
2

2.5bostons

#20
understand why you are confused

I understand why you are confused:

Classic manufacturing model in America is built on inspection, approval format which makes a person inspecting thier own work seem unethical.

This classic model is being challenged and changed daily in all industries...

For example we are currently changing to a cell manufacturing format which the assemblers are also the inspectors: they are responsible for the quality of thier product, it heightens thier awareness of final output.

My mentor drove this adage: you cannot inspect quality into a process or product, you CAN build it into the process or product.

I hope this helps.
 
Thread starter Similar threads Forum Replies Date
Techilady Ford Special Characteristics Communication and Agreement Form (SCCAF) provides production requirements? FMEA and Control Plans 4
thisby_ Post Market/Production Risk Assessment ISO 14971 - Medical Device Risk Management 0
Felony Melony Project Milestone Plan-Development to Mass Production APQP and PPAP 2
M Difference between "Production Trial Run" and "Run at Rate" IATF 16949 - Automotive Quality Systems Standard 8
M Material incoming to the production process reflected in PFMEA FMEA and Control Plans 9
C Scrapping on production floor - Setup parts 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 14
T IATF Rules for sharing production space with another company IATF 16949 - Automotive Quality Systems Standard 10
qualprod Best practice to ensure inputting of data in production Lean in Manufacturing and Service Industries 19
R Monitor production quality - Internal KPIs Manufacturing and Related Processes 5
E Routine production tests - dielectric voltage withstand test IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
Anonymous16-2 Dietary Supplement Raw Material/Component Storage and Production Manufacturing and Related Processes 1
L Significant Production Run - How 300 was determined to be the minimum quantity APQP and PPAP 2
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C Production and Post Production feedback - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
DuncanGibbons How is the arrangement between Design and Production organisation envisaged? EASA and JAA Aviation Standards and Requirements 4
J Production Line Test Brasil - High Voltage Dielectric Strenght Test Other Medical Device Regulations World-Wide 5
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
S How do you record your Nonconforming product? Batch production of staged processes Nonconformance and Corrective Action 2
A When there is a 2 year lapse in production, is a full FAI required? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P Definition of production tooling in IATF16949 clause 8.5.1.6 IATF 16949 - Automotive Quality Systems Standard 4
Moncia Production Planning procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Pre-Production Capability Assesment Reliability Analysis - Predictions, Testing and Standards 5
N Calibration Requirements for Production Equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Production of raw materials in university labs? Lean in Manufacturing and Service Industries 11
D How long should we keep the spare parts available for our medical device, after we have stopped the production? ISO 13485:2016 - Medical Device Quality Management Systems 0
V ISO 9001: 2015 Production drawing Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Determining Calibration Frequency schedule for items used in production Manufacturing and Related Processes 2
T Customer audit demands - that I state in my QM who can shut down production AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
R IATF 16949 Clause 8.5.1.6 a) maintenance and repair facilities - Production tooling management and personnel IATF 16949 - Automotive Quality Systems Standard 4
Ed Panek Bringing Production In house ISO 13485:2016 - Medical Device Quality Management Systems 10
Q IATF 16949 certification without automotive products in "production" IATF 16949 - Automotive Quality Systems Standard 5
Ed Panek Small Medical Device company - Bring production in-house ISO 13485:2016 - Medical Device Quality Management Systems 1
Mr Skeleton PV (Production Validation) test plan responsibility APQP and PPAP 21
D Valeo 5 Axes and VPS (Production System) Lean in Manufacturing and Service Industries 1
C Medical Device Stability Studies - Non-validated pilot production Other Medical Device Related Standards 1
Ed Panek Moving from Contract Manufacturing to Production In-House ISO 13485:2016 - Medical Device Quality Management Systems 3
andika_untoro What are a good Critical to Quality (CTQ) metrics for a biotech manufacturing production? Lean in Manufacturing and Service Industries 0
Ed Panek Bringing Production in house from Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
L Why is initial production units, lots, or batches, or their equivalents required for Design Validation? US Food and Drug Administration (FDA) 3
chris1price MDR Conformity Assessment for a Class 2a device - Production Quality Assurance EU Medical Device Regulations 2
Ed Panek Observational Audit of Contract Manufacturer Production ISO 13485:2016 - Medical Device Quality Management Systems 5
P AS9102 full FAl or a partial FAI after production inactivity period AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Sidney Vianna AS9100 News PPAP in the Aerospace Sector - What is it? AS9145 - Requirements for Advanced Product Quality Planning and Production Part Approval Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
W AS9120B 8.5.1 Control of Production and Service Provision AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
N In-Process Production Test Stations in PFMEA (Process FMEA) FMEA and Control Plans 18
qualprod Methods to Calculate Available Production Rate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
T Logic that determines what production testing is needed ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom