Designing a Nonconformance Management Process

T

tomvehoski

#21
I can't quite grasp some of your cost catagories for a NC. "Parts Supplied Incorrectly" sounds more like a root cause than a cost. The cost would be "Customer Reject". You might be making it too complicated. You don't have to capture everything at the initial event. You can come back to the record over time and add in the costs are they are realized. I'm not too sure about trying to capture

I am setting ours up with catagories such as:

Scrap - Internal
Scrap - By Customer
Rework - Internal
Rework - By Customer
Freight - Internal
Freight - Expedited
Penalty - Line Down
Admin
Travel

Lets say that I shipped 10,000 widgets to my customer. They called to complain that they are finding 50% defects. They demand I send someone to sort parts, and get them replacement inventory because I am shutting their line down. I buy my Q tech a plane ticket to go sort parts for two days. I also have our people sort the additional 50,000 pieces we have in inventory. Turns out exactly 50% of the parts are bad, so I have to remake them. My cost is $1 each. My costs probably look like:

Travel - $1000 (flight, hotel, meals, for two days)
Sort - At Customer: $300 (two days wages for my on-site person)
Scrap - At Customer: $5000 (5000 bad units)
Penalty - Line Down: $10,000 (lets say they hit me for $2000 for each of five hours they were down)
Sort - Internal: $800 (40hr @ 20 per)
Scrap - Internal: $25,000 (25K bad units)
Rework - Internal: $30,000 (replace my and customer inventory)
Freight - Expidited: $500 (next day air charges to replace bad units)

You get the idea. I highly recommend setting up catagory - subcatagory like I did so people can easily find them in a list.
 
Elsmar Forum Sponsor
M

munkee

#22
I can see your confusion I have not really explained the system correctly. We have seperate procedures for customer complaints and anything that we do wrong which the customer picks up on.

The system I am producing will be picking up nonconformances within the business only. This is basically to ensure we capture wasted costs i.e. anything we do wrong internally which costs us money to put right that the customer will not pay for.

For example if a machine breaks down the customer will not pay for the machine to be repaired, nor for the money we spend in overtime to ensure the delivery remains on time. The company is multinational and therefore we have had the categories I have supplied in my previous post mandated. How we chose to use them seems to be up to however the particular division wants to. But we are required to report outward in those categories.

As you said, I do not need to get every part of the event information during the initial report however due to the number of issues we have we need a way to categorise what is coming in so we can do analysis and basically hit the worst offenders first. Because of this I would like to be able to categorise the nonconformance description.

The user will be able to describe the event, select what category this description falls in to and then go on to describe why it happened (this is not root cause analysis this is just their view to help add context for later investigation).

In my opinion the categories I posted in my previous post are linked to the cost and therefore as you have shown need to be used to help build up the multiple parts to the overall cost, which is what I have planned to do but I will also add in a few extra categories since as you have shown they do not cover enough of the options.
 
Q

QCAce

#23
...
The user will be able to describe the event, select what category this description falls in to and then go on to describe why it happened (this is not root cause analysis this is just their view to help add context for later investigation).

In my opinion the categories I posted in my previous post are linked to the cost and therefore as you have shown need to be used to help build up the multiple parts to the overall cost, which is what I have planned to do but I will also add in a few extra categories since as you have shown they do not cover enough of the options.
I agree with your approach, changing your data collection categories to match the nonconformance types, (i.e. breakdown, part abc damaged, etc). This will allow you to report on the top nonconformance issues that are occuring, and you will then also have some background comments from operators when you start your corrective action analysis.

Secondly, as you stated previously, you can then set up a second table containing nonconformance types and the related cost amounts and cost categories for each nonconformance type. However it has been my experience that the efforts needed to develop and report the quality cost data will not bear much fruit.
 
M

munkee

#24
Thank you for the confidence boost QCAce that I am heading in sort of the right direction. However I cant for the life of me begin to think how I could categorise a nonconformance description, especially since I am trying to capture the internal issues. These could be endless?!

I mean as a basis I could have:

Breakdown
Incorrect Work
Late Work
Incomplete Work
Rework
Unscheduled event
Missing Work
Additional Work
Cost overrun
Poor communication


But as you can see, I have to be very broad with interpretations and call things "work" when this could range from a document, to a piece of steel. Also some of these seem to just be driving down in to a root cause such as "poor communication". I just cant seem to get my mind set right to be able to create a category selection for an event description. The only one which seems to always stick right is "Breakdown" because it is pretty unambiguous.

p.s. Here is a picture of the web page that will be used to report nonconformance events. This sends data to the access database. As you can see I am trying to sort out the non conformance type categories at the moment. I will add some screenshots of my database tomorrow so other cove members can get some ideas if they choose to go this route in the future. The ? symbols show tooltip style help for filling in information with examples of possible entries.
 

Attachments

Last edited by a moderator:
Q

QCAce

#25
It depends on the type of work being done and the product. We have fabrication and assembly departments (work areas). Attached is a sample of one of our data collection forms and also a sample of some of our reported data from last month.
Hope this helps.
 

Attachments

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#26
I am playing around with Mantis. It is an open source bug tracker like Bugzilla, runing off of MySQL. I wouldn't have documentation and everything done until the end of the year.
 
M

munkee

#27
I think the issue is that since I will be picking up types of nonconformance from so many different departments I will have to have categories which are very broad.

In the future I will be able to design in categories that are more specific to the department/area that are reporting but that will all be done once the first run has been done and the system becomes more customised.

I have had a look at mantis before it is quite simple for bug tracking and I'm sure it would be customisable for a companies needs. I will be eventually moving my back end database to mysql server and using web page front ends but that is a few versions in the future I imagine.
 

Pancho

wikineer
Super Moderator
#28
I am playing around with Mantis. It is an open source bug tracker like Bugzilla, runing off of MySQL. I wouldn't have documentation and everything done until the end of the year.
We are using bugzilla, but I've read very good stuff about Mantis. Please do let us know how that works out for you.
 

Pancho

wikineer
Super Moderator
#29
But as you can see, I have to be very broad with interpretations and call things "work" when this could range from a document, to a piece of steel. Also some of these seem to just be driving down in to a root cause such as "poor communication". I just cant seem to get my mind set right to be able to create a category selection for an event description. The only one which seems to always stick right is "Breakdown" because it is pretty unambiguous.

p.s. Here is a picture of the web page that will be used to report nonconformance events. This sends data to the access database. As you can see I am trying to sort out the non conformance type categories at the moment. I will add some screenshots of my database tomorrow so other cove members can get some ideas if they choose to go this route in the future. The ? symbols show tooltip style help for filling in information with examples of possible entries.
Hi again Munkee,

I agree with you that your categorization may be already driving into a conclusion. Wouldn't it be better to let the analysis reach the root cause?

FWIW, we use a few "types" for NCs: client_complaint, audit, wip_complaint, raw_material_rejection, preventive. These we combine with, in a separate field, the process where the NC arose. This categorization minimizes a possible bias in the resolution.

In the "description" field we enter the facts only. We then have a "correction" field. We use "comments" for opinions. The analysis of the root cause is entered later (by the process owner) as is the CA.

Pancho
 
M

munkee

#30
Thank you for the reply pancho.

I actually do have a root cause area but this is derived during the investigation.

My main form within my database where investigators of a nonconformance work is broken down in to the following pages:


nonconformance overview = all information submitted initially by the reporter

costs = allowing multiple costs to be assigned to the nonconformance as they are realised, this is broken down to be able to add in estimated/actual and assign them a category and department who has incurred them.

Investigation = This allows for notes of who has been involved, methods used and then an area to report each root cause (as there can be multiple). Root causes are also categorised for example, not following procedure, out of date documentation etc. A start date for the investigation and an end date. Finally the outcome of the investigation which for now is two options of "Use as is" or "correction required". This has a reasoning box next to it so they can describe why the conclusion has been reached and who has signed it off.

Corrections = Corrective actions which are broken down in to seperate actions/start dates/proposed end date/actual end date who is the owner/who is carrying the action out and what the action is. Then finally a section to mark the nonconformance for closure and recommendations.


So as you can see, there is categorisation right through the sytem which is great for analysis however, I do not want to have to use qualitative analysis to understand what is actually being reported initialy. I would prefer the initial reporter to suggest what category their nonconformance event description falls in to. This would then allow me to do trend analysis on a department and business perspective associating costs and root causes along the way. I can then help to steer the business in the right direction not just the departments.

But as we have both said, it is hard to make choices on what the initial categorisation is without driving down in to a root cause. By all means I do not mind users stating what they "think" but I have always said you should let the data tell the story and not be driven by "gut feelings". However, with that being said if I can categorise nonconformance events coming in, I can use data to drive priorities and do the right things first.

To put it in perspective, our business is looking at 1,300 internal nonconformances this year, amounting to profit loss in the millions (wasted time, rework hours mainly) :nopity:. We have chosen to use the categorisation of events to show us what our biggest issues are (pareto analysis easiest way) and then do thorough investigations on these and bring their occurence rate down thus reducing costs until we are at a manageable level to investigate everything coming in to the system thoroughly.


p.s before anyone says it, we do actually have a nonconformance system which is concerned with customer delivery however my system will be lookin at internal nonconformance, at the same time the first system is becoming very out dated and support for it is set to end soon so our quality department are looking for a replacement which may end up being this one once it has been fully tested/refined/audited.
 
Thread starter Similar threads Forum Replies Date
S Earthing of moving parts, designing tips IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Designing new gauge tracking software IATF 16949 - Automotive Quality Systems Standard 4
A Leadership Role in Designing QMS - Upper Management Support Quality Manager and Management Related Issues 16
S Designing the experiment with minimum run Statistical Analysis Tools, Techniques and SPC 0
S Designing the experiment with minimum run Statistical Analysis Tools, Techniques and SPC 0
B Designing a Sampling Plan - AQL AQL - Acceptable Quality Level 19
F Designing a Hollow Medical Device for Autoclavability Other Medical Device and Orthopedic Related Topics 2
Claes Gefvenberg Designing Supplier Questionnaire Forms Supplier Quality Assurance and other Supplier Issues 25
M Designing a Quality Assurance and Control System Quality Manager and Management Related Issues 3
P Sheet Metal Design: Standard method for designing Electrical Knockouts Design and Development of Products and Processes 7
N Designing an attribute MSA for a new piece of metrology equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
R Line Balance Simulation when Designing a New Production Line Lean in Manufacturing and Service Industries 1
D Designing a Training Course called "Role of the Laboratory Quality Manager" Training - Internal, External, Online and Distance Learning 13
A Designing a Documents Control System from scratch (in a php intranet) Document Control Systems, Procedures, Forms and Templates 5
K Designing a gauge to check the Axis of Snorkel of Axles Design and Development of Products and Processes 5
A Designing a Closed Loop Water System using Adiabatic Cooling Towers Manufacturing and Related Processes 5
R AS9100C Clause 7.3 Design & Development - Designing a System and Procedures AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S API Std 620 vs. API 650 standard? Which is the least restrictive in designing a tank? Manufacturing and Related Processes 1
A Designing an Ethylene Oxide Sterilization Process Other Medical Device Regulations World-Wide 7
Q Are there any threads specifically concerned with designing with AutoCAD? Design and Development of Products and Processes 1
P Designing a "part-specific" Receiving Gauge - Gauge first or job? Design and Development of Products and Processes 4
C Designing Control Charts - Variable with Small Variation and Tight Control Limit Statistical Analysis Tools, Techniques and SPC 20
C Designing control chart for non-normal variables Statistical Analysis Tools, Techniques and SPC 3
A Is the Assembly of the Prototype after Designing considered a Production Process? Design and Development of Products and Processes 11
M Designing a scope for APQP Design and Development of Products and Processes 2
B Designing a Test Part to Assess CMM Operator's Knowledge Design and Development of Products and Processes 9
D Designing an ISO 9001 Internal Audit Training Course - Need Help Internal Auditing 6
S Project Management QMS - Manufacturing and Designing of Special Purposed Machines Design and Development of Products and Processes 5
L Categories for data collection - Designing a form for when errors occur Nonconformance and Corrective Action 6
J Designing a Mil-Std-105 or ANSI/ASQ Z1.4 Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 49
R Designing and building our own machines Design and Development of Products and Processes 5
V Designing an integrated ISO 9000 - ISO 14000 System in a Big Marine Port Design and Development of Products and Processes 3
S US Success in Designing & Manufacturing World-Class Goods Design and Development of Products and Processes 2
Claes Gefvenberg Document control applications - Be very wary about designing your own Document Control Systems, Procedures, Forms and Templates 4
F 8.2.1 Customer Satisfaction - Designing & Building a Solid waste disposal facility ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
O Need documentation - Designing a data acquisition system for the enviromental chamber Design and Development of Products and Processes 3
N Nadcap AC7101/2 Rev. E Section 3.2 - Nonconformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
T Internal Nonconformance procedure thoughts (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
C NCR (Nonconformance System) Software Nonconformance and Corrective Action 7
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
E When to generate a nonconformance report ISO 13485:2016 - Medical Device Quality Management Systems 6
K Counterfeit parts prevention - Audit Nonconformance - AS9100 8.2.2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 25
qualprod When to write up a nonconformance and require a NCR - We produce labels ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
PhilM Nonconformance report, Customer complaint investigations and RMAs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Medical Device Directive - Seeking common nonconformance write up scenarios CE Marking (Conformité Européene) / CB Scheme 2
CPhelan Nonconformance opened as incorrect expiration date placed on received product. Escalate to CAPA? Nonconformance and Corrective Action 4
qualprod Ineffective follow up of people performance - Audit Nonconformance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q AS9120 7.5.3.2 Control of Documented Information - Audit Nonconformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
qualprod Criteria to raise a Nonconformance based on KPI values ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 39

Similar threads

Top Bottom