Stuck at 'Analyse' stage of DMAIC Improvement Cycle on Cosmetic Specification

A

aj2002

#1
Hi everyone,

i work in a medical industry where we manufacture medical devices, more specifically sleep apnea devices. my manager has asked me to develop a visual standard/cosmetic specification for various products with the company. i have used the six sigma approach, more specifically the DMAIC improvement cycle to help solve for the problem at hand.

i have currently finished the 'Define' and 'Measure' stage of the DMAIC improvement cycle and found that we have a potential million dollar opportunity within the company. however i am stuck at the 'Analyse' stage. can some please advise what i should be doing in this stage, what i should be looking for and so on.

thank you so much!
aj
 
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Steve Prevette

Deming Disciple
Leader
Super Moderator
#2
I'd suggest taking a lesson from the PDSA cycle and try a few things and see how they work. Run through many trial and error cycles. Visual standards can be tough to develop, but see if you can gather photos of "good" and "bad" examples and try them out with inspectors to see if they are helpful. Those that pass the prototype stage can then be refined and you move into the I and C parts.
 

Miner

Forum Moderator
Leader
Admin
#3
Since your goal is to develop a visual standard, you might start with some experiments on different approaches to visual standards and how that affects the attribute MSA results. If there is an existing standard that you are trying to improve, use it as a baseline for comparison with a new approach.
 

Jim Wynne

Leader
Admin
#4
Hi everyone,

i work in a medical industry where we manufacture medical devices, more specifically sleep apnea devices. my manager has asked me to develop a visual standard/cosmetic specification for various products with the company. i have used the six sigma approach, more specifically the DMAIC improvement cycle to help solve for the problem at hand.

i have currently finished the 'Define' and 'Measure' stage of the DMAIC improvement cycle and found that we have a potential million dollar opportunity within the company. however i am stuck at the 'Analyse' stage. can some please advise what i should be doing in this stage, what i should be looking for and so on.

thank you so much!
aj
Because there's a perceived need for visual standards, presumably what you have or what you're doing isn't working up to expectations.
  • Look at how visual evaluation is being done now, and look at failures.
  • Determine specifically why the current methods don't work.
  • If you have samples of unacceptable product, analyze them and think about how you might use so-called boundary samples to help people understand what's acceptable and what's not. Do the same with samples that may not be perfect but are considered acceptable.
 

Bev D

Heretical Statistician
Leader
Super Moderator
#5
ask your customers what they expect for cosmetics - what do thy like what do they say they dont' like
look at any returns/compalints regarding cosmetics - what actually don't they like?
 

TWA - not the airline

Trusted Information Resource
#6
Could you please elaborate on the main results of your D and M phase? This will help the Covers to better understand your situation and needs, especially regarding the Analyze stage as requested (In the DMAIC cycle you typically define your problem and decide how to quantify it, then you measure to do the quantification and by analyzing your data find the approaches for improvement...)
 
A

aj2002

#7
Could you please elaborate on the main results of your D and M phase? This will help the Covers to better understand your situation and needs, especially regarding the Analyze stage as requested (In the DMAIC cycle you typically define your problem and decide how to quantify it, then you measure to do the quantification and by analyzing your data find the approaches for improvement...)
The outcome of the M stage is that there is a significant opportunity to reduce vast amount of non-value added activties that occur when processing a NCD due to cosmetic defect. that opportunity stands at approximately $1,000,000 (this is a fact by the way, proved it via analysing various data). So potentially improving the current visual standard that is more aligned with the company ideals on quality, the suppliers, and the customers should be then cascaded throughout the supply chain which will defninitely help minimise this significant opportunity.
 

TWA - not the airline

Trusted Information Resource
#8
So it seems your D phase is just the statement "We have a problem with too much fallout for visual defects" and the M phase is "This amounts to a total loss of money of X". In that case, I'm afraid there is nothing you could analyze right now. If you had data like simple check sheets that would give you data on how much NC units and with which specific failure mode (color issue, scratches, etc.) you have on different machines, different shifts etc. or how the NC rate depends on the QC operator then you could analyze data and get to the issues that need addressing. In your case you need to do root cause analysis with tools like 5xWhy, Fishbone diagram, Cause-Effect Matrix or even Brainstorming. It might be that your current spec is too tight and you might get the marketing people to accept things a little bit less than perfect. It might be that your spec is too generic and some or all QC guys are too picky without further guidance what would be considered a blemish that needs to be sorted out. It might be that for some other part of the inspection QC uses magnifiers and now finds things that your normal customer would not or just find acceptable when seen with the naked eye...
There is probably much more. Hope this helps...
 

Bev D

Heretical Statistician
Leader
Super Moderator
#9
hmmm. I think I will reply within the DMAIC construct although my suggestions are really independent of what 'milestones' or phases you choose.
Also - as you will see in this response - actions in the various phases can 'peanut butter' across phases...

In Define we should describe the technical problem to be solved (as well as quantify the potential benefits). "too much fallout for visual defects" is a good start but its really more along the lines of a 'business' problem.
Indefine we woudl specifically state what the defect is: waht is the characteristic, what constitutes acceptabel or unnacceptable levels (ie specifications) The next step in this example should be to determine what actually constitues a visual defect. This can be a very detailed action - more so than in other investigations. Your Customer msut define this. you can use actual returns from Custoemrs, direct verbal feedback, any specifications they have given you or feedback from your sales/marketing folks who should know what the Customer wants...This entails listing defect types (scratches, gaps, blemishes, color mismatch, etc.) and their acceptable/unnacceptable limits.

In Measure, the primary action is to perform an MSA. absolutely essential for this type of project. The goal here is to determine if part of the fallout is due to 'over-rejection' of acceptable parts. You will need to collect defects from the line and determine if they are truly defects based on the criteria establihshed in Define phase. You will need to include parts that DON'T meet the rejection criteria but soem people rejected tehm anyway. you will also need 'good units' that weren't rejected by the inspectors. The total number of parts should be sufficient to contain a representative portion of defective parts, rejected but good parts and good parts not rejected as measured by your baseline data. You might want to check out this document on how to conduct the MSA (see teh section of Categorical Data) as well as this Spreadsheet for the analysis (see the tab on Kappa repeatability to assess each individual inpsector against the truth and the Grouped kappa tab to compare inspectors to each other, there is also a tab for Mcnemer's test). However, just looking at the results in a table of each inspectors results vs truth for each defect category will be sufficient to tell you what you need to go 'fix' as far as inspection accuracy. The statistical output is really only good for those who must have it. ;)

You may find in Measure that a good portion of your fallout is due to over rejection. However a substantial part of the fallout indeed be warranted. Then you must enter the Analyze phase: here you will investigate what causes the cosmetic defects. in all liklihood each defect type will have a separate cause. You might find this article helpful in your first steps to determining causes.
 

TWA - not the airline

Trusted Information Resource
#10
Bev,

great summary of how it should be done. From aj's posts I get the feeling that the focus is primarily on the business problem and that they first need to understand the real problem (and maybe learn a bit more about the DMAIC cycle) before they will be able to proceed.
 
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