Bringing new products to market

Problem Analysis case study Mt. Fuji

Houston we have a problem! Just the mention of the familiar phrase from the 60s, more specifically the word problem, increases your heart rate, raises your anxiety level and creates a tightening in the pit of your stomach. We have all dealt with problems of various magnitudes in both our personal and business lives. Some are easy to resolve, the fix is easily identifiable, while the solution to other problems is not readily apparent. When dealing with problems in our work environment, the situation is compounded with different personalities, hidden agendas and varying degrees of facts. One approach to problem solving is a system that I discovered many years ago while attending a workshop on The Rationale Process presented by Kepner-Tregoe (K-T). The K-T Problem Analysis process helps provide a team approach to systematically gather facts, create possible causes and screen the possible causes to help identify the most probable cause. Yes, I know, the previous explanation is highly over simplified so let me use a real life example of how we used the K-T Problem Analysis methodology to get a major product development effort back on track. Situation: A major supplier of hospital products was developing an innovative packaging system which required the creation of new hardware and a complex multilayered laminate sheeting material. Several highly talented groups were working together to provide the materials and equipment required for the project. The project was progressing fine until that dreaded phrase sir, we have a problem. One of the team members noticed that a white powdery residue was accumulating on a forming mandrel which is part of the packaging machine. The discovery of the residue raised a minor panic because no one knew the source, the content or what caused the powder to appear. Initially both development groups worked independently to resolve the problem, but in short time both parties started to point the finger at the other group instead of working together to resolve the problem. Did a design change in the equipment create the problem, material formulation changes that caused the problem or were there other variables that contributed to the problem? To find the answers everyone needed to work together as a team and not as individual departments. The one Page 1

Bringing new products to market thing that both groups could agree on was the nickname Mt. Fuji for the problem since the powder residue on the forming mandrel resembled the mountain along with the fact that the material was sourced from Japan. A meeting was quickly arranged were I would facilitate the K-T Problem Analysis process to the material development group and the equipment engineering group. As a prerequisite, each team member was requested to bring all of their notes and data about the material and equipment design to the meeting. A brief description of Unshakable Facts, written by Harold Geneen (CEO of AT&T), was sent to each participant to illustrate the difference between fact and opinion. The intent here is to have available as many facts as possible to support the analysis. Too often opinions are regarded as fact and steer the problem analysis in the wrong direction. Step 1 - Problem Definition The definition of a problem is described as follows: Event Should Actual Deviation Actual Should

At the beginning of a process what should occur and what actually occurs are the same. At some point in time there is an event that causes the Actual to differ from the Should. This difference is defined as a deviation. The first critical step is to agree on What is the deviation? The goal here is to identify an object with a defect. The more specific the better and the defect should be limited to one type of defect. Not to be confused with 10 units out of 100 are defective, but those ten units all have the same defect. If multiple types of defects occur, then it may be difficult to narrow down to one solution. The team quickly defined the deviation as White powder residue accumulating on the forming mandrel.

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Bringing new products to market Step 2 Fact Gathering Before starting this exercise, I always reiterate the importance of using unshakeable facts. I explain how opinion vs. fact leads to poor decision making. Opinions may enter into the process as long as the comment is flagged as an opinion. We may find out later in the process that what is often identified as an opinion is the starting point to collect more data to generate additional facts. The fact gathering phase attempts to fill in the following matrix: Is What? Where? When? Extent? Is Not

Typical questions to address are as follows: What is the deviation? What is not a deviation? Where does the deviation occur? Where does the deviation not occur? When did the deviation occur? When does the deviation not occur? What is the extent of the deviation? What could be the extent, but is not?

The following helps illustrate the type of data for each category. Is What? Where? Soft, white powder. At location were sheeting makes a sharp bend on forming mandrel. Observed on DD/MM/YY Observed on material lot# XXZZWW. Small amount on mandrel after X feet of sheeting processed. Forming mandrel not damaged. Is Not Metallic, granular. On rolling components of equipment. No scratching of plastic sheeting Not observed on unused rolls Prior to DD/MM/YY Other lots not #XXZZWW Excessive amount immediately. Wearing down of forming mandrel.

When? Extent?

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Bringing new products to market Step 3 Develop Possible Causes In determining the possible cause, distinctions or changes need to be identified. What has changed from prior to the deviation to after the deviation? List all known changes no matter how insignificant. These could include personnel, weather, design changes, lot number changes, assembly methods, time of day, time of year. Two significant changes occurred near the time of this event. The first was a modification to the forming mandrel three weeks prior to discovery of the white powder. The second was a formulation change to the sheeting produced in Japan. Due to the length of time from initiating the material change, to scheduling production and finally the time to ship from Japan to the US, it was unclear as to which lot numbers were affected by the change. One persons opinion suggested that sheeting with the new formulation had been used prior to the discovery date. Using the list of changes and the data matrix, the team should develop possible causes. The intent here is not to qualify the possible cause, but to generate many possible causes. Several possible causes are as follows: 1. The forming mandrel is scraping plastic off of the sheeting. 2. The sheeting is wearing down the forming mandrel causing metal flakes/powder to accumulate. 3. The material was not cleaned properly causing dirt to collect on the mandrel. 4. The material formulation has changed. 5. Cleaning solutions for the equipment are leaving residual powders. Step 4 Test for Most Probable Cause After brainstorming possible causes, the team then runs each possible cause through the data matrix to see if the cause can be supported by the facts. If not, the cause is eliminated. The process continues until the most probable cause is supported by all of the facts. The following are examples of how the previous possible causes relate to the facts: 1. 2. 3. 4. 5. Sheeting does not display any signs of scratching after being pulled over the forming mandrel. The forming mandrel was evaluated and there was no evidence of metal degradation or wear. Material is cleaned prior to use. Unclear as to when the formulation change occurred. Need more data. Powder not on other machine components.

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Bringing new products to market In some cases, a solid cause is not found but plausible causes are determined. These plausible causes require additional testing to validate or invalidate. Step 5 - Verifying the Cause and Fixing the Problem Additional data was obtained while the group continued to work through the process. The data showed that the manufacturing lot number of the material used when the powder was observed was indeed the first lot received with the new formulation. This still did not confirm the possible cause, however, did define additional data collection activities to verify the cause. The lot number dates were confirmed. Testing of the powder residue was conducted and confirmed it was the new ingredient in the material formulation.

In the case of the Mt. Fuji problem, it was discovered that a material formulation change caused the problem. The material development group thought the formulation change had been implemented in previous tests when the defect did not occur. Upon review of lot number shipping records, manufacturing dates and testing dates the material change in question matched exactly when the deviation was observed. Identifying the actual cause allowed the material development group to focus on a resolution that included an understanding of what caused the ingredient to accumulate on the forming mandrel and to implement a fix. Use of the K-T Problem Analysis process averted a major delay in the project and prevented deterioration in team morale. The initial K-T Problem Analysis exercise was completed during a 3 hour meeting. Follow up activities were completed in less than one week. The impact to the overall success of the project: priceless.

For more information about Kepner-Tregoe and their products and services, please visit their website: www.kepner-tregoe.com. Page 5