Manufacturing Process Flow Chart.
Information | Understanding | Best Practice.In manufacturing processes, the flow chart is often the first step in designing a process, then when the process has been established, the flow chart is applied as part of process improvement, problem investigation and staff training efforts. Manufacturing processes are ideally suited for analysis via flow charting, due to the consistent, logical, linear flow of such processes, with standard operating instructions, defined decision points and specific inputs and outputs.
Many manufacturing processes are designed with a range of software and automated controls, flowcharting facilitates the identification of such controls via specific symbols.
The first step in utilizing a chart is to define the team of individuals who have the necessary understanding of how the process actually operates. This will often require representatives from some or all of the following functional areas: product design, manufacturing personnel, quality assurance, regulatory affairs, materials, finance, IT, suppliers may input into the process, clinical affairs, the customer may be represented, etc..
When developing the flow chart, the focus needs to be on the actual process “as happens”. Therefore, customer complaints, internal audit observations, deviation reports, rework histories, yield data, should all be referred to, in order to help develop an understanding of where actual practice may not have reflected expected process design. Understanding the causes of process failings will help in building an accurate picture of how the process currently operates.
Revising the process flow.
When there is agreement that the flowchart reflects the “actual” process, the next step will normally be to identify opportunities for improvement. Improvement may be the elimination of in-consistencies within the process, or improving operating efficiency, etc.. With input from key relevant stakeholders (manufacturing, design, materials, quality, suppliers, customers, etc..) a brainstorm exercise can be implemented to identify changes to be implemented. Any proposed changes will need to be analyzed, cost benefit assessed, verified or validated in advance of actual implementation. There will also be a need to retrain staff on any process changes implemented. In most manufacturing environments especially in highly regulated industries such as medical device, pharmaceutical, bio-technology, …. there will be defined and tightly adhered to, change control procedures in place. Process flow charts are often released within the document management systems and therefore any proposed change will need to be implemented in accordance with approved procedures.
Flow charts as part of the Standard Operating Procedure.
Standard Operating Procedures (SOP’s) define how a process or activity is to be implemented. Many SOP’s can be quite detailed and extensive. While such detail may be necessary in order to fully describe the tasks to be performed, the effect can be daunting for the reviewer. In many manufacturing companies, a policy is taken to add a process flowchart into the appendix of SOP’s so that the reviewer can obtain a visual interpretation of the process which helps in developing an understanding of how the process operates, plus can also act as a quick reference guide.
Quality Management Tools and Techniques.
- Continuous improvement utilizing Analytical Techniques.
- 5 why’s analysis
- Process Flow Diagrams/Flowcharts/Process Mapping
- Check sheets /Check Lists
- Run charts
- Scatter Diagrams/Scatter Plot
- Cause and Effect/Fishbone/Ishikawa Diagrams
- Identifying sources & causes of variation
- Control/Shewart Charts/DPU Charts
- Cpk and Ppk Analysis
- Pareto Analysis
- Bottleneck Analysis
- Etc. Etc.
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