The reason that CAPA is an important tool to incorporate into an organization is because it demands high quality management. In order to deal with the processes involved in CAPA the organization needs to be accurate and flexible. Organizations that typically implement CAPA include automotive, sciences, manufacturing and aerospace operations. It is typically linked with other improvement processes such as Lean and Six Sigma methodology.
Corrective action processes are made up of several stages. The first is to identify and document the reason for the problems occurrence. After this, the whole systems processes need to be viewed and analyzed in order to confirm that similar problems will not occur. The effect of the problem has to be analyzed by finding out when the problem was realized and the impacts it had on the product or service itself.
Sometimes appropriate action is required in order to handle the situation, which can involve telling the customer, recalling products or discarding products completely. The follow up is an important last stage because it allows the organization to assess whether the problem was handled effectively and if the possibility of it reoccurring has been eliminated.
Preventive action processes involve taking the necessary actions in order to guarantee that an error will not occur. It is often necessary to have an analysis performed of the system and its processes, which will help determine the requirements for changes involved so that the problem does not occur.
This is typically performed by assigning a team to a project that focuses on improvement, which can include plans for progress, discussions about change, the resources that will be required and then evaluating their findings. Preventive actions require a set program of activities that allow for change to be implemented and monitored. It is best to space out the stages of the set over a longer period of time in order to note the progresses and to make evaluation more meaningful. It is important to communicate the ideas about what has taken place and what has been done to help team members communicate in a productive way.
About the author:
Shruti Bhat PhD MBA Certified Lean Six Sigma Black Belt is Pharmaceutical R&D and Continuous Improvement Director, Innoworks Canada
Shruti leads path-breaking product development programs such as Complex Generics, Nanotechnology and Targeted delivery systems for pharmaceuticals and natural products. Her mantra is to "Shorten development timelines, build quality-by-design, lean processes and bring products fast- to- market". Shruti integrates her proficiency in Design Thinking, Lean, Kaizen and other Continuous Improvement methodologies to improve R&D processes, productivity and profitability.
Shruti is Product Development & Continuous Improvement Advisor to several start ups, mid-size and growing firms in Canada, USA, India, Africa and other Emerging markets. Shruti has authored six books and is an invited speaker at several conferences and workshops.
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