Process method documents are always subjected to changes
due to process improvement which strive for variation reduction that lead to
quality improvement. Improvement could
be from other process input mainly material and machine (tooling design, jig
and fixture, equipment setting, software changes). Once improvements are made,
the new ways of transforming product need to be captured in new document or
revised the existing documents.
It is imperative that we need to follow rigorous document
control process which is major element in quality management system. One of
the key aspects in document control is managing manufacturing process document
changes. No matter how successful is the
process improvement, if there is no proper documentation of the improved
methods, and then it is equal to nothing?
Normally in manufacturing entity, most organization
follow proper process change notification (PCN) or engineering change
notification process (ECN).
Recommended engineering change process would be:-
- Identify the potential change which could improve the current method of transformation in manufacturing process.
- Propose the change in engineering change notification (ECN) system.
- List down which process input are impacted from the change such as man – operator training required and machine - special tooling required or new setting
- Ensure improve action plan which lead to changes in the process are reviewed and authorized by all stake holders
- Trial run the change (process improvement) in pilot scale. The parts for pilot must represent the population of the process.
- Generate a report of the pilot batch which includes the key metrics of quality and productivity.
- Evaluate the results feedback loop to check the effectiveness of the change through production parts.
- Once the change full fill its intention, document all changes in formal document such as work instruction according to company document control procedure.
- Develop a system to ensure all change notifications being implemented in the applicable area
- After the change is implemented in mass production, there must continuous monitoring to ensure it is successful in mass production.
Proper documentation of the changes is also called for in
six sigma methodology under standardization.
In standardization we are required to capture all changes which can
improve the process in official documentation followed by proliferation
throughout the manufacturing entity.
The outcome of method, work instruction which capture 3
process inputs (Material, machine and method).
Therefore method is the most dynamic process input as other process
inputs changes could impact work instruction.
Since change management is very tedious process, it is
best that we could follow advance quality planning approach to invest more time
in developing proper design and process FMEA to minimize change. Changes could
also bring unnecessary variation to the process and product.
The most essential process input method is the
documentation of how a product is being transformed in the form of work
instruction (WI) or standard operating procedure (SOP). WI/SOP had to be simple and easy to follow
and there must governing process to ensure all operators follow the same work
method to reduce variations.
Summary of process input method:-
- The best method which documented clearly for each unit operation in manufacturing (work instruction, SOP).
- Overview of end to end process deploying process management plan (PMP).
- Transportation, kitting and packaging must be included in method of product manufacturing.
- Manage changeover , human and product with structural approach to reduce variation during changeover in production
- Manage change to ensure the latest improved method are document and operator follow the latest revision in production floor.
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| Change for the better |
