The Quality Blog

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Preventing failure saves time, money, and lives.

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I would first explain that if I had a design or process which was potentially catastrophic (sev 9 or 10) I would attempt to error proof the Failure Mode (if cost permits) then I would explain criticality (combo of Sev and Occurrence) where I could draw a picture of why reducing Occurrence was my primary course of action, where I could either error proof the cause or improve the process capability of the machinery/tooling (or improve tolerance if the design was not fully completed yet)  and then finally, I would look at detection for items at risk based on the first two. Actions are determined at each step, Three times in the development process I can take an action. Once actions have been recorded I calculate RPN, assign RPN to each action and re-rank the RPN after the verification or validation of the effectiveness of the action. (wheeew that is a lot of words)

The popular 5 Why technique has been used in problem solving for some time. Some even swear by it. I have found that the 5 Why technique does not actually allow the team/users to find the root cause. It points to where to look but is not fundamentally able to refine the info needed to close in on the root cause(s). I like to use Is?Is Not as a way to build the criteria for testing my theories, but more important than that, Is/Is Not allows us to compare the differences and look at the process and or environmental changes that may have contributed to the difference in the Is and Is Not.

Without the discipline of a technique used to take facts and perform the comparative analysis, 5 Why may go off into weird directions. (Some of you knw what I mean)

Best to use 5 Why to get to the point where facts are not available and switch to a more useful fact gathering technique.

Just a quick note to all who follow this blog, We have made available the latest Severity Occurrence and Detection tables as well as other quality and apqp related information on our website. These are pdf’s and can be copied and used during FMEA development or APQP, DVP&R etc… Take a look at these and download to your hearts content. They are free, but you must register on the website.

http://www.quality-one.com/products/reference.php

Come to the QAI website (www.quality-one.com) on Wednesday and see our new intro video!

Much has been said about outsourcing, some good and some bad. What cannot be debated is that outsourcing is here to stay and it is a cost effective way to manage an important part of your business. Outsourcing your supplier process is one of the areas which can be quite effective (cost and performance) if done professionally. Let me explain.

Supply Chain Management is not just about ranking a suppliers ability to meet IOS or TS requirements. It encompasses a relationships, sourcing decisions, engagement levels, quality of systems as well as performance and future development to attain even higher levels of performance. These elements must all be included in a supply chain management strategy. If not, a significant amount of inefficiency can take place.

It has been estimated by industry insiders that a full 33% or 1/3 of the energy spent on suppliers is redundant or could be done in a more integrated way. While it is agreed universally that supplier engagement in product development activities almost always returns a benefit in simplicity of designs with lower costs/price. Engageing too late when suggestions for design for assembly or manufaturing cannot make it into the design, is a common sentiment.

Supply Chain management is often left up to different departments with little or no coordination and results linked not to a process but to individual SQA/STA (supplier developmemt engineers) experience.

Outsourcing the complete Supply Chain Management function provides several benefits:

1. One focused organization looks at sourcing, engagement, collboration, performance and development instead of possible different departments.
2. Integration reduces amount of time per supplier and emphasis is placed on high value products and processes
3. Cost can be shared across many OEM’s where generic data, and development activities would benefit many customers instead of individual customers
4. Suppliers can share in the expense of being managed

In summary, I do not mean to say that all organizations do not practice effective Supply Chain Management, I am suggesting that expertise exists, that could do an equally effective job (or better) and do it at a cost that is competitive or below what internal resources are doing it for today.

Does anyone have a comment or question?

http://www.quality-one.com/services/supply-chain-management.php

What is Failure Mode Avoidance? FMA is the effort taken to organize and report the failure history to be used at the very beginning of a new product or process development. The non inclusive list of sources of the Failures are as follows:

• Warranty
• Campaigns (recalls)
• DV Test failures
• Continuous Improvement Activities/Six Sigma DMAIC
• Production Line Failures
• Customer/Assembly Failures

These are summarized and actions are required at Design reviews to show haw the item was either

• Error Proofed (designed out)
• Made more capable (Cpk 1.67 or greater for high volume production)
• Mistake Proofed or Controlled

The value of FMA (or FPA Failure Prevention Analysis) is mostly avoiding current problems from happening again, and lost time in design if the item requires revisiting. For many companies 30% of all failures are repeats.

What have we learned and how to avoid it must be an integral part of the Product Development process and Lean PD.