TGFR Consulting LLC The CAPA (Corrective and Preventive Actions) process represents a key element of any Quality Management System. In order to conduct a successful CAPA root cause investigation and as a result achieve a successful CAPA outcome, use an “Is/Is-Not” exercise to establish the true problem scope
The “Is/Is-Not” Exercise – Establishing the True Scope
Many times, the scope of the issue or problem statement that kicks off a CAPA process has gaps, leading the subsequent investigation to miss the mark. To establish the true scope, the first step in CAPA planning is an “Is / Is-Not” exercise. An “Is / Is-Not” exercise establishes
- What – what exactly is the problem facing the team or orgranization
- Where – where does the problem occur
- When – when does the problem occur
- Extent – what is the extent of the problem
As the team works through the “Is/Is-Not”, they should consider the answers these critical questions
- What does the. team know to be true about the problem?
- What does the team know to not be true to the problem?
The following provides guidance on the Is/Is-Not exercis.
What is the Exact Problem?
Many times the problem statement is vague or unclear. The original problem statement often comes from sources that may not be able to define the problem in terms that support effective investigation. In order to establish the exact problem, the team should challenge the scope through a number of challenge questions. These can include such things as
- Is this a user related error or a problem with the product?
- Does the problem represent something causing consumer risk (a risk to the people using or being treated by the product) or producer risk (a risk to the organization manufacturing the product)?
- What is appeared, that is, How does the problem appear (what is observed)?
- What is the overall risk
This effort will drive the scope and will feed all the other elements of the Is/Is-Not
Where does the problem occur?
Based upon the scope, establish where the problem is occurring. Here are questions that can establish the where associated with the problem
- If the problem relates to consumer risk, what is the environment (use, preparation, shipping)
- If the problem relates to the use, are there geographic considerations (the problem appears in some countries or regions more often)?
- If the problem relates to the producer risk, is this a problem related to the supply chain, the manufacturing process or distribution? Be careful not to make judgements, but by limiting the areas of focus, investigations gain focus?
When does the problem occur?
This question tries to establish the time based characteristics of the problem. This can be more than time of day or season, but also can describe that the problem is intermittent. Here are some questions that relate to the when
- Is there a seasonal element?
- Is there a time or day of the week element?
- Is the problem regular or intermittent. Does it come and go or appear regularly
What is the Extent of the problem?
This question tries to establish the overall occurrence rate. Here are some questions that relate to the extent?
- What is the occurrence rate? Does the problem occur at a high or low rate?
- If the problem relates to consumer risk, do all the users see the issue? Are there certain user populations?
- If the problem relates to consumer risks, does every manufacturing lot see the issue?
Completing the “Is / Is-Not” exercise
As part of answering the What/Where/When and Extent questions, detail the associatedl data, and identify any additional data needed to clearly define the “Is/Is-Not”. If you don’t have solid data, the team may need to identify and collect more data to effectively answer the questions. This data collection exercise becomes a critical part of the overall investigation plan.
The “Is/Is-Not” Format
The following figure Illustrates the “Is/Is-Not format”
| Focus | Aspect | Associated Data | Additional Data Collection | Is | Is-Not | Comments |
| What | This is a description of the problem | Describe existing data associated with the problem statement | Describe additional data associated that should be collected | Preliminary Is | Preliminary Is-Not | |
| Where | This is a description of where the problem occurs. | Describe existing data associated with the where statement | Describe additional data associated that should be collected | Preliminary Is | Preliminary Is-Not | |
| When | This is a description of when the problem occurs. | Describe existing data associated with the when statement | Describe additional data associated that should be collected | Preliminary Is | Preliminary Is-Not | |
| Extent/Size | This is a description of extent/size of the the problem. | Describe existing data associated with the extent statement | Describe additional data associated that should be collected | Preliminary Is | Preliminary Is-Not |
Additional Reading
What is an Is-Is-Not analysis and how to conduct one
Is/Is Not Analysis: A Powerful Problem-Solving Technique for Peak Performance