General Support Areas
Structured Problem SolvingInformation Many business problems exihibit the characteristic pattern of performance shown in this illustration.
The trended change in performance provides clues to the cause(s) of the business problem.
A decline in process performance is often due to changes in one or more of the key process inputs or controls.
Successful problem analysis involves understanding the state of the inputs before, during, and after the observed change in performance.
With this understanding most challenging business problems are effectively solved within 10-15 days of rigorous assessment.
Hover over graphics for more info
- Problem Analysis
- CAPA Corrective and Preventative Action Assessment
- Problem Prevention
Many organizations use structured methods for solving business problems. These methods range from the 8D approach developed by FORD and used across the automotive industry to the Corrective and Preventative Action (CAPA) approach used in the regulated lifescience and healthcare industries.
Despite extensive efforts over the years to create efficient and effective problem-solving methods, many organizations are still challenged to achieve the desired results. Read more to understand how your team can improve its methods of root-cause analysis and develop a more effective problem-solving approach.
Process Design and ImprovementInformation The goal of process improvement is to elevate the process to a higher level of performance.
Key to achieving successful process design and/or improvement is identifying the critical imputs that affect process performance.
Identifying the critical inputs requires us to understand how the process inputs work together to produce the desired process results.
- Process Understanding & Design
- Lean Implementation
- Process Validation MethodsMethods used to verify the process can meet all customer and regulatory requirements on a consistent and predictable basis.
The focus of efforts in many process intensive industries such as the chemical, pharmaceutical, food, vaccines, and medical device includes the development, validation, and improvement of each process that touches the product. Given the rich evolution of these efforts over the past 75 years we would expect to see stellar performance across all cited industries. However, many organizations still struggle to reap the full benefits of years of knowledge building.
What stands in the way of achieving desired results on a consistent basis? Read more to learn about process design, improvement, and validation support opportunities with us.
Process Lifecycle ManagementInformation When a process remains in a state of stationary control it varies about its target in a predictable manner.
All performance observed within the process control limits is determined by the existing system design.
Any performance observed outside of the process limits is unique or different than expected by design.
Managing a process to achieve consistent and predictable performance requires us to understand the effect of each input on process variation and which inputs are best controlled to maintain the process on target with low variation.
- Risk Management
- Process Capability and Control
- Acceptance Sampling Plans
To sustain the benefits of good design and improvement practice your organization should exercise good process control discipline. Knowledge of the critical process variables is essential to this effort, but not sufficient. In addition, your team needs to understand how the variation of all critical inputs combine to produce the variation in process performance. This is a daunting task that many organizations fail to complete, and as a result risk significant loss of revenue and customer value.
We can help your team develop economic practices for managing processes that yield robust and consistent performance. Read more to see how.