Having explored the topics of “Why Investigate?” Because it is mandated by both Good Manufacturing Practice (GMP) regulations —21CFR211 and Quality Systems regulations—21CFR820. “What to Investigate?” You are required to investigate the cause(s) of nonconformities relating to product, process, and the quality system. “When to investigate?” As soon as the non-conformance has been identified; I’d like to shift the focus now to the topic of identifying the actions that are required in order to correct and prevent the recurrence of non-conforming products from entering the marketplace.
The step of identifying actions plays a critical role in the investigation process. The purpose of this step is to identify the best permanent and systemic corrective actions to eliminate the root cause of the event and prevent its recurrence both now and in the future. Based on the level and extent of the investigation as well as the root causes identified, a decision will be made that will serve to provide overall the greatest benefit while ensuring that the lowest risk have been identified.
Once you have thoroughly investigated your event of noncompliance and have identified the root cause of your problem, you need to identify the action(s) necessary to correct the problem. Actions may fall into the following categories: (1) initial correction(s) that once taken will correct the problem; (2) permanent corrective action(s) which may be more systemic in nature and may involve longer-term action(s) to eliminate recurrence of the problem; and (3) preventive action which are actions taken to eliminate a potential non-conformity and will usually involve systemic changes that will help to ensure that there are systems in place to sustain the identified actions over time.
Let’s take a look at each type of actions. “Initial corrections” are those actions that are clearly and easily identifiable as steps to be taken that will “correct” the problem. “Correction” refers to repair, rework, or adjustment necessary and relates to the disposition of an existing nonconformity. Those actions fall under the category of what I like to refer to as “stop the bleeding”. For example, a piece of equipment that had been fully operational suddenly springs a leak due to a worn out gasket. An immediate initial correction to the problem may be to shut the equipment off and replace the gasket. This correction is immediate, will resolve the urgency of the situation and will return the equipment to its normal operating state. However, it does nothing towards identifying the second type of action which is long-term, corrective action.
"Corrective action" relates to the elimination of the causes of an existing nonconformity. Corrective actions that seek to eliminate the cause of an existing nonconformity are more systemic in nature and may involve process related changes; changes that impact the way in which the daily operations take place; and/or changes to procedures, work instructions, etc.
“Preventive actions” are those actions that identify and eliminate the causes of potential nonconforming product and other quality problems. These actions may involve analyzing your current processes, work operations, and other quality records to ensure that these actions would indeed prevent a recurrence of the event.
The step of identifying actions plays a critical role in the investigation process. The purpose of this step is to identify the best permanent and systemic corrective actions to eliminate the root cause of the event and prevent its recurrence both now and in the future. Based on the level and extent of the investigation as well as the root causes identified, a decision will be made that will serve to provide overall the greatest benefit while ensuring that the lowest risk have been identified.
Once you have thoroughly investigated your event of noncompliance and have identified the root cause of your problem, you need to identify the action(s) necessary to correct the problem. Actions may fall into the following categories: (1) initial correction(s) that once taken will correct the problem; (2) permanent corrective action(s) which may be more systemic in nature and may involve longer-term action(s) to eliminate recurrence of the problem; and (3) preventive action which are actions taken to eliminate a potential non-conformity and will usually involve systemic changes that will help to ensure that there are systems in place to sustain the identified actions over time.
Let’s take a look at each type of actions. “Initial corrections” are those actions that are clearly and easily identifiable as steps to be taken that will “correct” the problem. “Correction” refers to repair, rework, or adjustment necessary and relates to the disposition of an existing nonconformity. Those actions fall under the category of what I like to refer to as “stop the bleeding”. For example, a piece of equipment that had been fully operational suddenly springs a leak due to a worn out gasket. An immediate initial correction to the problem may be to shut the equipment off and replace the gasket. This correction is immediate, will resolve the urgency of the situation and will return the equipment to its normal operating state. However, it does nothing towards identifying the second type of action which is long-term, corrective action.
"Corrective action" relates to the elimination of the causes of an existing nonconformity. Corrective actions that seek to eliminate the cause of an existing nonconformity are more systemic in nature and may involve process related changes; changes that impact the way in which the daily operations take place; and/or changes to procedures, work instructions, etc.
“Preventive actions” are those actions that identify and eliminate the causes of potential nonconforming product and other quality problems. These actions may involve analyzing your current processes, work operations, and other quality records to ensure that these actions would indeed prevent a recurrence of the event.
Regardless of which type of action(s) are taken to correct the problem and prevent the recurrence of non-conforming products and other quality problems, verification or validations of these actions is the final step in this process. You must verify or validate the actions in order to ensure that the fixes or potential fixes will in fact address the root cause of the event and does not adversely affect the finished product.
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