In last week’s blog, I talked about “what to investigate” when dealing with non-conformities relating to a product, process, or the quality system. In investigating these non-conformities, FDA’s expectations of the manufacturer / producer are as follows: (1) investigate to identify the source of the non-conformity; (2) contain the non-conforming product to ensure that it does not reach your customers (subsequent blogs will discuss containment at length); (3) Identify the action (s) needed to correct the problem and prevent recurrence of nonconforming product and other quality problems; (4) Verify or validate such actions to ensure that they are effective and does not adversely affect the finished product; and finally (5) Implement the changes that you have deemed as valid during the course of the investigation and monitor for effectiveness.
This week, I want to focus your attention on the question of “when to investigate?” The issue of timeliness of an investigation plays a critical role in any investigation process. The first twenty-four (24) hours after the identification of a non-conformance is of significant importance and goes a long way in ensuring that you will be able to identify the root cause of the problem (as opposed to a symptom of a much larger problem) and implement effective corrective actions.
Whether you are in an Analytical Laboratory conducting chemical analysis or in a manufacturing facility that produces medical devices, the timeliness within which you identify the non-conformance and officially begin your investigation is extremely important.
Critical information may be lost or rendered “inconclusive” when an investigation into a non-conformance is delayed. This lost or “inconclusiveness” of information may be due to that fact that the stability or shelf-life of the material(s) used in the analysis is unstable. For example, if the sample in question has a 24 – 48 hours shelf life and you begin your analysis on Friday, re-analyzing this same sample on Monday morning (once you have identified that you have a non-conformance) may not provide sufficient insight during the course of the investigation in the determination of a potential root cause. A re-sampling and re-analysis may provide passing results but the validity of the original sample preparation remains “inconclusive” since that sample is now technically expired.
The same principle holds true for a medical device manufacturer. One example which I have seen in my past experience is in manufacturing a device in which a process has been validated as time dependent. That is, there is documented evidence to show that a delay in the execution of an activity may yield unfavorable or nonconforming results. If this activity step is to be carried out within let’s say, 24 hours, the evaluation of the outcome of this activity should be conducted shortly thereafter. When it is not, timeliness of the investigation becomes an issue and results in greater difficulties in attempting to arrive at a root cause.
Therefore, the answer to the question of “when to investigate” depends upon the process, product, or quality system under scrutiny. When should you investigate? Most definitely, as soon as the non-conformance has been identified. However, A good rule of thumb is to begin your investigation at least, within the first twenty-four hours post completion of the activity in question.
This week, I want to focus your attention on the question of “when to investigate?” The issue of timeliness of an investigation plays a critical role in any investigation process. The first twenty-four (24) hours after the identification of a non-conformance is of significant importance and goes a long way in ensuring that you will be able to identify the root cause of the problem (as opposed to a symptom of a much larger problem) and implement effective corrective actions.
Whether you are in an Analytical Laboratory conducting chemical analysis or in a manufacturing facility that produces medical devices, the timeliness within which you identify the non-conformance and officially begin your investigation is extremely important.
Critical information may be lost or rendered “inconclusive” when an investigation into a non-conformance is delayed. This lost or “inconclusiveness” of information may be due to that fact that the stability or shelf-life of the material(s) used in the analysis is unstable. For example, if the sample in question has a 24 – 48 hours shelf life and you begin your analysis on Friday, re-analyzing this same sample on Monday morning (once you have identified that you have a non-conformance) may not provide sufficient insight during the course of the investigation in the determination of a potential root cause. A re-sampling and re-analysis may provide passing results but the validity of the original sample preparation remains “inconclusive” since that sample is now technically expired.
The same principle holds true for a medical device manufacturer. One example which I have seen in my past experience is in manufacturing a device in which a process has been validated as time dependent. That is, there is documented evidence to show that a delay in the execution of an activity may yield unfavorable or nonconforming results. If this activity step is to be carried out within let’s say, 24 hours, the evaluation of the outcome of this activity should be conducted shortly thereafter. When it is not, timeliness of the investigation becomes an issue and results in greater difficulties in attempting to arrive at a root cause.
Therefore, the answer to the question of “when to investigate” depends upon the process, product, or quality system under scrutiny. When should you investigate? Most definitely, as soon as the non-conformance has been identified. However, A good rule of thumb is to begin your investigation at least, within the first twenty-four hours post completion of the activity in question.
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