Process Control Development
For manufacturing process control, there is a certain set of pattern for personnel to ensure all potential risks can be controlled and mitigated . Therefore, the following four steps below can be a reference process flow for manufacturing personnel to initiate process control design.
Before understanding how to control the process, generate a process flow diagram to have an overview and identify respective stations. This helps people who do not know the process to have a quicker understanding of the abstract of the production line before going into details.
Use process/design FMEA to identify potential risk during the design phase or process failures. In design FMEA, core element of failure shall be based on the potential risk generated from the product’s function failure. While process FMEA focuses more on the failure mode during the production from incoming raw material up to finished products.
After consider and evaluated all potential risks, Control Plan will be list respective process/product parameters which needs to be controlled and recorded. Control Plan shall also have the recording method of parameters and respective countermeasures when abnormality occurs.
Since production process needs documented procedure, record forms indicates the process evidence is documented and ensure the process is well recorded for reference.