Changing Existing Quality Culture/Program - Where to Begin?

T

Toefuzz - 2006

#1
Greetings all! I'm not sure where I'm going with this post, so please bear with me as I try to organize a few of the jumbled thought bouncing around in my noodle.

I work for a small, family owned (my family), job shop that finishes metal product supplied by our customers. Much of our process involves manual labor and manual inspection, most of which is performed by relatively uneducated individuals, though they do know their job. Because this is a family business comprised of people who have been here for 15 years plus the resistance to change is outstanding. Some aspects of our quality system have been nagging me for some time now so I'm trying to organize a plan of action... What do I need to do, how should I go about it, prioritizing, etc but would like to know what other people are doing as a sort of benchmark before I present my ideas.

We do produce a high quality product and in general our customers are very happy with us. I guess what's bothering me is the reactive nature of our quality system. It seems that when a problem does arise with a customer we typically have very little empirical evidence proving we are not at fault for the issue at hand. The world of business is changing and as unfortunate as it is, the deal and a handshake days are pretty much gone, especially when dealing with the automotive companies. To protect ourselves we do monitor several aspects of our process multiple times per day and randomly sample parts from each production run for long term durability testing (salt spray, humidity, etc). What bothers me is that customers will often complain that our finish operation reduced the diameter of a hole to below spec. All too often this hole will be below spec before we began processing it, but we do not track this and have no proof other than our word (and as I said, that just doesn’t cut it nowadays).

I guess my question for you is this: Where in the world do I begin? I know, nice and specific there, ‘eh? My thought is that we need to have some sort of inspection on incoming customer product. To save time this should be on some sort of sliding scale, the most common offenders receiving the heaviest inspection, the fewest receiving little to no inspection (unless a problem arises, then inspection is stepped up). The problem is that many of the defects aren’t visible to the human eye until we finish the part. Still, it seems it might be worthwhile to measure any critical characteristics/dimensions as called out on the print. We would then need to inspect finished goods for the same criteria.

Also, I would like to look at implementing some sort of SPC program… Any recommendations on how to go about it? My thought was to sit down with the appropriate personnel and determine the variables critical to our process. We would then track the variable for awhile, determine high and low ranges, and continue tracking using statistical tools. Does this sound like the correct way to go about thigns?

Again, I apologize for the long and vague nature of this post… I’m hoping that as I discuss this with you things will begin to clarify in my mind and I can ask more specific questions.
 
Elsmar Forum Sponsor
J
#2
Some ways to start....

I don't know how much help this will be but.....

In companies where the management is satisfied with the overall operation your best bet is to look for incremental changes. What Jennifer refers to as Stealth Quality. Often times management will choose to eat certain costs rather than antagonize a big customer. Have you done any cost analysis on the problems?

SPC to control your processes would be a very good idea in my opinion. Try approaching it from the standpoint of learning and documenting the knowledge that your workforce has. Also you can use the cost savings aspect. That by knowing and controlling the processes better it's easier to find the most economical ways to do things.

As far as incoming inspection goes, that's a bit trickier. It kind of depends on how much the defects are costing both directly and indirectly. I do agree that the customers with the most complaints need to have these addressed, of course you wish to :ca: Take a look at the cost factors and what would be the most beneficial way to approach it. Have you considered asking the customer to supply you with an inspection report on problem parts?

Where you have long time employees who "Have always done it this way", the key is patience and a determination to "learn" from them. Keep them involved as full fledge partners. As you begin to show improvements in the processes and, especially, making their jobs easier and more productive, you should get sufficient buy in.
 
#3
Toefuzz said:
I guess my question for you is this: Where in the world do I begin?
Perhaps by having a look at old threads on similar subjects? I know that others have faced similar problems and posted here about it.

I suggest The Elusive Culture Change , but there are many more scattered all over the Cove. Make good use of the Search function, it will be worth the toil.

And hey: Good luck :bigwave:

/Claes
 
V

vasilist

#4
Hi Toefuzz!!

i am the last to give advices since i am young but i will try to tell you the following :

- since it is family job (- and this is the most important - YOUR family) i guess things are better than if the job wasn't yours family. What i mean is that IF you want to walk the road of Quality the first thing you need (apart from being qiality oriented) is GM's support. In your case i understand that your family should support you in your work.

- since you are talking of culture , take a look and see your workforce. What is their perception of quality? In my opinion one of the nice things you can do is to train them. "Perpetual Education" will give them the basic background to turn their actions into "quality".

Again i am not THE experienced quality guru but i am quality oriented and i have worked in many bussines environments as a quality assurance manager. Some of them were supporting "Q" some other not. I have seen both sides of the coin. Good Luck in your quest!!!

vasilist
 

RCW

Quite Involved in Discussions
#5
A couple of general suggestions

Toefuzz,

Some general comments/suggestions:

1) I too had to establish a quality system within a resistant, family-owned organization. A big suggestion is to keep EVERYONE within your organization envolved with the development of the quality system. Yes there will be a lot of head butting but you are also developing ownership of the system which should, quote-unquote, help with acceptance.

I did just the opposite. I was put in a time crunch mode where a quality system needed to be developed. After doing most of the development work myself, I am now the sole owner owner of the quality system ("It's a QUALITY system. It's the responsibility of the QUALITY manager.") If I had it to do all over again from scratch, I would promote more ownership.


2) To quote from Emil Faber and the movie "Animal House" (am I dating my self here?), "Knowledge is good." There is a ton of good quality system/tools information on the web, in books, and especially here at The Cove:applause:. While it might take time to do research and accumulate this knowledge, it will be well worth it. I have seen "Gotta have it right away" projects and also "planned & organized" projects. Guess which ones were more successful and lasted longer? (If you picked the latter you receive a gold star for the day.)

Good luck in your endeavors!
 
Last edited:
D

Don Palmer

#6
I feel your pain

RCW said:
I did just the opposite. I was put in a time crunch mode where a quality system needed to be developed. After doing most of the development work myself, I am now the sole owner owner of the quality system ("It's a QUALITY system. It's the responsibility of the QUALITY manager.") If I had it to do all over again from scratch, I would promote more ownership.
I'm in the same boat, having been brought up out of the rank and file, to develop with a contracted consultant (manual writer) our quality system. I too am sole owner throughout the year until audit time.:frust:

It's tough to get genuine buy-in after the fact.
 
Thread starter Similar threads Forum Replies Date
C Design Change needed for Changing an Angle in existing Product from 15-25 degrees? ISO 13485:2016 - Medical Device Quality Management Systems 11
A Changing Notified Body EU Medical Device Regulations 6
H Traceability after changing the machine IATF 16949 - Automotive Quality Systems Standard 13
M Changing Investigational Device from Non-Sterile to Sterile - what are the implications? Other Medical Device and Orthopedic Related Topics 3
Q Changing calibration frequency Calibration and Metrology Software and Hardware 18
S Changing revision status of a reviewed document Manufacturing and Related Processes 11
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
D Clothes changing in pharmaceutical factory Manufacturing and Related Processes 8
M Changing supplier of critical raw material (III class device) Other Medical Device and Orthopedic Related Topics 1
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T AS9100 - Changing PEARs target AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 41
C FDA on changing acceptance criteria re: analytical method validation US Food and Drug Administration (FDA) 1
V Statistical basis and justification while comparing / changing sampling plans Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
K Changing from Procedure based to Process based Competency Evaluations General Auditing Discussions 5
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Marc Email Addresses - Changing your email address Elsmar Xenforo Forum Software Instructions and Help 0
supadrai OEM Changing the name of the manufacturer - length of process? Is 1-3 months correct? Other Medical Device Regulations World-Wide 0
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
A IMDS - Changing the Locked Weight Value RoHS, REACH, ELV, IMDS and Restricted Substances 1
D Changing Templates Approval Field Document Control Systems, Procedures, Forms and Templates 5
P Romer Arm - Profile of a Surface Changing General Measurement Device and Calibration Topics 4
D Changing software classification via software - IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
L MINITAB 17 - Changing Data Using Minitab Software 3
S Process validation when changing location ISO 13485:2016 - Medical Device Quality Management Systems 10
Don Fardie CAPA vs. Risk Assessment - Changing a product material for better performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Changing Registrars Registrars and Notified Bodies 15
MDD_QNA Changing the Layout of Medical Device Label(s) CE Marking (Conformité Européene) / CB Scheme 3
S Keeping track of the changing Medical Device Standards Other Medical Device Related Standards 3
J Changing of our New Hire Orientation Training Records Training - Internal, External, Online and Distance Learning 12
A Changing a Form Template & Updating Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Is anyone changing their ISO 14001:2004 EMS Policy? ISO 14001:2015 Specific Discussions 8
Q Changing Terminology in ISO 9001:2015 - Documentation Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V Changing Indication of Use for a Class IIa Medical Device EU Medical Device Regulations 2
B Changing out Thermocouple - Is new calibration required? General Measurement Device and Calibration Topics 1
F Rules to respect when changing from Certification Body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
MDD_QNA Clinical data requirements - Changing a Class I Medical Device to Class II EU Medical Device Regulations 5
shimonv Changing the Label of a Medical Device product in the field Other US Medical Device Regulations 5
E Information required about changing an off shelf part 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Changing FMEA template to include Detection Ranking for the PFMEA FMEA and Control Plans 2
WCHorn Changing Sampling Accept Number to Zero, Arbitrarily AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
M Amending CFDA Registration for changing site of shipment China Medical Device Regulations 2
S Gage R&R on Potentially Changing Parts - Guidance Needed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Re-registration of medical device in Russia - "changing holder" Other Medical Device Regulations World-Wide 1
R Changing CE Mark on Documentation ISO 13485:2016 - Medical Device Quality Management Systems 2
K Changing the Auditor within a Notified Body ISO 13485:2016 - Medical Device Quality Management Systems 4
B Process Capability - Changing Limits to Improve Cpk or find Root Causes? Capability, Accuracy and Stability - Processes, Machines, etc. 6
M Changing Notified Body - Anyone have stories to share CE Marking (Conformité Européene) / CB Scheme 3
R Changing ISO 9001 Certification Scope Quality Manager and Management Related Issues 4
W Depth Gage Spindle moved when changing Contact Point Calibration and Metrology Software and Hardware 6

Similar threads

Top Bottom