Process Characterization is a method to identify and quantify the significant source of variation. In other words, the purpose of process characterization is to provide objective evidence that critical product parameters and associated process parameters are consistently capable of meeting customer requirements.
When to use Process Characterization
In a small or big organization, many products and process quality characteristics exist. A single component usually has several quality characteristics and but which parameters to check? Also, 100% inspection is not generally a good idea for quality assurance – we just don’t have the resources to check everything in the world.
The process parameter capabilities ideally should track/correlate with product parameter capabilities. Include only the parameters thought to be critical for the characterization, but not all. However, start with the Critical to Quality product parameters given by the client and focus only on the process parameters that deliver those.
If we’ve done a round of this, but the product is still bad, check the process parameters. Acceptable indices for identified process parameters may all be good, but if the team did a lousy job of identifying which process parameters truly have an effect on the product parameters, one might see the process parameters as acceptable, but the product is not acceptable.
Why Process characterization
Process characterization is a vital step in most of the manufacturing sectors, especially drugs and pharmaceuticals. Often it is a mandatory step for manufacturers to validate the product manufacturing process. It ensures the manufacturing process delivers consistently a quality product that meets the customer and regulatory requirements.
Objectives of process characterization studies
Design of experiments (DOE) and ANOVA are the best statistical methods to categorize the most important variables for process control. Below are the few objectives of process characterization studies.
- Classify the process parameter that impacts product quality.
- To determine the product acceptance criteria and operating ranges.
- Evaluate the interactions between CTQs and process parameters.
Selection of process control elements
In the Improve Phase of DMAIC, the Six Sigma teams implement the process improvements. Once the improvements are in place, it is important to monitor the process. Key process input variables (KPIVs) may be analyzed to determine the degree of their effect on the process output variables. It is also known as KPOVs.
Some important considerations for the selection of process control elements
- Elements that are important to customers and regulatory requirements
- Variables that impact human safety
- Elements that customers request
- Process variables that impact the product yield
- Items that are running high internal and external defects
- Variables that helps to reduce the operating cost
- Items that are easy to collect and analyze
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