Information & Training presentations.
Achieving Continuous Improvement in Products & Processes
Continuous improvement requires an analytical approach to understanding current process status, an understanding of the causes of variation from design intent, a clear definition of desired process performance and an ability to comprehensively apply improvement methodologies.There are a number of critical stages to implementing effective process improvement. These progress from developing a clear understanding of the problem to be addressed, followed by the performance of fact based analysis, identifying the root cause, then after determining potential solutions to address the problem, implementing the optimum solution(s) and monitoring the outcome to ensure that the original problem has been addressed. When implementing the solution, you need to ensure that the problem stays addressed, via ensuring procedures are in place, training and staff competence are sufficient, and the implementation of a regular audit program.
Finally and a key component of on-going effective process improvement is recognition of success by those charged with addressing a problem.
Continuous Improvement. Information & Training presentations.
Product and Process Validation.
SPC & Statistical Methods for Process Improvement.
Risk Management.
Medical Device Validation, Regulation, Classification.
Quality Assurance, Quality Management Systems.
Lean & Just-In-Time Processes.
Quality Management Tools & Techniques.
Software Validation.
Details >>>
The steps in process continuous improvement.
The first step is to ensure a “clear understanding of the problem to be addressed”. This is absolutely essential. Without a clear understanding, various members of a problem solving team can place differing emphasis on widely varied aspects of a problem to be addressed. Often there can be disagreement on the problem specifics. Before any root cause analysis is commenced, define the problem, explain what exactly needs to be addressed, document and ensure all involved buy-into the task ahead.Fact Based Analysis and Root Cause Identification.
The next step is to perform “fact based analysis”. Where possible remove any potential for blame, you want to focus on the issue and see what needs to be performed to address the problem. The problem to be addressed, may relate to a material deficiency, process equipment stability and reliability, supplier quality performance, etc.. The problem may relate to individual work performance, if so, what needs to be performed or implemented to address, so the problem does not repeat. You need to use fact based investigative tools and techniques. Maybe apply a cause and effect analysis, or a fault tree analysis, 5 why’s, HAZOP analysis, etc.. Apply a method of investigation that forces detailed analysis based on the available facts.Once the problem has been investigated there may be a clear cause, range of causes, or list of potential causes. In this latter case, there may be a need for experiments or some form of testing to be performed to move from potential causes to actual causes. It is essential to keep investigating until you get to the stage where there are clear root causes.
Process improvement solution implementation.
When the causes are identified, what solutions can be implemented to address? This may involve the introduction or new materials, new processes, new equipment, new specifications, new methods of training, etc.. It is essential that the introduction of new change is implemented in a controlled manner. There should be a defined change control process, so that the introduction of change does not in itself create new problems. For example, if a modified material is introduced into a process, then all the potential impacts need to be identified up front, for example, staff competence and training, documented records, material obsolescence, storage, handling, … etc..Monitoring to ensure the continuous improvement is permanently implemented.
The optimum solution(s) is then implemented and reviewed to determine impact. The critical consideration at this point in the process is to ensure an effective problem solution has been implemented. Therefore, the implementation results need to be monitored both in the immediate term after the solution change implementation and in the longer term. As part of the implementation, procedures may have been revised, staff may have been retrained, etc.. It is important to ensure that the solution implemented stays permanently in place and cannot deviate or revert back to the original state. Many organizations may plan-out a series of follow-up audits or inspections to verify continued effective solution closure.Recognition of improvement.
Once the problem has been addressed, the final step is to ensure that the success of the effort has been recognized. This is an important yet often overlooked aspect of effective process improvement. Recognition may take the form of an article in a company newsletter, a thank you email copied to peers, a personal thank you from a senior manager at a company meeting. The more personal the better and where management take time to recognize efforts by staff, the greater the potential for future successful process improvement activities.
Continuous Improvement. Information & Training presentations.
- Product and Process Validation.
- SPC & Statistical Methods for Process Improvement.
- Risk Management.
- Medical Device Validation, Regulation, Classification.
- Quality Assurance, Quality Management Systems.
- Lean & Just-In-Time Processes.
- Quality Management Tools & Techniques.
- Software Validation.
- Details >>>
References:
Quality Management Principles. International Standards Organisation.
FDA – Quality Considerations for Continuous Manufacturing. The FDA draft guidance for industry “Quality Considerations for Continuous Manufacturing.”