In my last blog I discussed the importance of evaluating responsibilities in an investigation and the associated documentation required as supporting evidence. Today’s blog will discuss investigating root causes as it relates to following established protocol and procedures.
In any failure or nonconformance investigation, the procedure(s) that govern the process under investigation play a key role in the determination of root causes. Once a nonconformance has been obtained, the investigation procedures must be detailed enough to answer or address the following:
-What are the necessary steps to control product disposition?
-What are the required approvals?
-Timeframes for acquiring approvals and product disposition?
-Timeframes for actual investigation?
-Development of a plan of action
Nonconformance investigation procedures must clearly define product disposition and the necessary approvals for the actions taken. Depending on the nature of the nonconformance, the risk that the organization is willing to assume, as well as the governing procedures, product disposition may dictate: use-as-is, quarantine, scrap, or rework. Whatever option is selected, the rationale for this decision must be clearly evident and governed by departmental procedures. A decision to use-as-is, for example, should not be left to the discretion of individuals who are not authorized to make such decisions, nor provide the justification for such use.
Nonconformance investigation procedures must also dictate the timeframes for acquiring approvals as well as the disposition of the product. In any nonconformance investigation, time plays a critical role and any unnecessary or timely delays may result in loss of vital information critical to the investigation. Therefore, it is essential that the investigator or other applicable personnel adhere to the established timeframe requirements in order that the flow of critical information may be evaluated in a timely fashion.
Nonconformance investigations procedures must also establish some clear foundation for a plan of action. This plan of action is not required to be so prescriptive as to prohibit or hinder the normal investigative flow. However, it should lay the preliminary foundation for the way in which the investigation is to flow. Action plans may incorporate as appropriate, to retest or resample; responsibilities for evaluating the data; as well as the required approvals of the data.
Depending on the nonconforming product as well as the procedures governing such products, each company must evaluate its own process and procedures for nonconformance investigation and revise as necessary to ensure that they continue to operate in a consistent state of control.
Wednesday, August 19, 2009
Tuesday, August 11, 2009
Evaluating Responsibilities
In last week’s blog, I discussed an oftentimes overlooked but nonetheless, significant element of a thorough QS or GMP investigation, namely, accurately defining the problem description, which is the nature of the nonconformance. In today’s blog, I will discuss the importance of evaluating responsibilities in an investigation and the associated documentation required as supporting evidence.
Once a determination has been made that a nonconformance has occurred, whether it be a product or process nonconformance, the responsibilities associated with the activities involved play a key role in the investigation process. The task of evaluating responsibilities is important for several reasons, but of significance are the following:
1. it helps to quickly define the tasks at hand and identify key roles and responsibilities
2. it sheds light on areas in the process that may be vulnerable to potential nonconformance
3. helps to establish a process for continuous improvement of the quality management system
In attempting to evaluate the responsibilities of the individuals involved in a process, one must evaluate the procedures associated with the tasks, in addition to conducting interviews with the respective individuals. I will briefly describe the relevance of each activity.
Evaluating responsibilities as it is defined in a given procedure is relevant in that it allows you to clearly identify the requirements as they are documented for a process. This sets the foundation for providing the evidence to substantiate the activities taken. Recall my motto in previous blogs: “if it’s not documented, it’s a rumor”. So, the fact that the responsibilities are defined in a given procedure is great, but do not stop there.
Next, you must interview the appropriate individuals to determine the “unwritten” responsibilities that are often a part of many activities in a given function. Those are what I like to call the “fluid” responsibilities that are often performed by individuals in order to: (a) clarify a task, (b) increase output, (c) facilitate better time management, and/or (d) “other”, which can include a host of other reasons. While any person working in an FDA regulated environment will quickly admit that following the procedure is foremost in their responsibilities, upon further investigation, you may find that points “a – d” above also is a factor in the way in which activities are performed in this environment.
In order for an investigation to be effective in determining the root cause of a nonconformance, the responsibility factor must play a key role. It must be made clear however, that in the process of evaluating responsibilities the individual(s) involved must feel secure enough to be open and honest about the activities that they have performed, both documented and undocumented. If individuals are fearful of losing their jobs, feel intimidated by the investigator, or are concerned that the outcome of the nonconformance may have a negative impact on future advancement opportunities within the company, then the effectiveness of this activity will be significantly diminished. Individuals must be made to feel that this is an activity that seeks to identify gaps/weaknesses in the process, not in the individual themselves.
Once a determination has been made that a nonconformance has occurred, whether it be a product or process nonconformance, the responsibilities associated with the activities involved play a key role in the investigation process. The task of evaluating responsibilities is important for several reasons, but of significance are the following:
1. it helps to quickly define the tasks at hand and identify key roles and responsibilities
2. it sheds light on areas in the process that may be vulnerable to potential nonconformance
3. helps to establish a process for continuous improvement of the quality management system
In attempting to evaluate the responsibilities of the individuals involved in a process, one must evaluate the procedures associated with the tasks, in addition to conducting interviews with the respective individuals. I will briefly describe the relevance of each activity.
Evaluating responsibilities as it is defined in a given procedure is relevant in that it allows you to clearly identify the requirements as they are documented for a process. This sets the foundation for providing the evidence to substantiate the activities taken. Recall my motto in previous blogs: “if it’s not documented, it’s a rumor”. So, the fact that the responsibilities are defined in a given procedure is great, but do not stop there.
Next, you must interview the appropriate individuals to determine the “unwritten” responsibilities that are often a part of many activities in a given function. Those are what I like to call the “fluid” responsibilities that are often performed by individuals in order to: (a) clarify a task, (b) increase output, (c) facilitate better time management, and/or (d) “other”, which can include a host of other reasons. While any person working in an FDA regulated environment will quickly admit that following the procedure is foremost in their responsibilities, upon further investigation, you may find that points “a – d” above also is a factor in the way in which activities are performed in this environment.
In order for an investigation to be effective in determining the root cause of a nonconformance, the responsibility factor must play a key role. It must be made clear however, that in the process of evaluating responsibilities the individual(s) involved must feel secure enough to be open and honest about the activities that they have performed, both documented and undocumented. If individuals are fearful of losing their jobs, feel intimidated by the investigator, or are concerned that the outcome of the nonconformance may have a negative impact on future advancement opportunities within the company, then the effectiveness of this activity will be significantly diminished. Individuals must be made to feel that this is an activity that seeks to identify gaps/weaknesses in the process, not in the individual themselves.
Wednesday, August 5, 2009
Elements of a Thorough Investigation- Part 3
In Elements of a Thorough Investigation- Part 2, I discussed the second aspect of a through Quality System or GMP investigation, and that is, determining the difference between people and process driven activities as they relate to a comprehensive investigation. In today’s blog, I will discuss an oftentimes overlooked but nonetheless, significant element of a through QS or GMP investigation, namely, accurately defining the problem description, which is the nature of the nonconformance.
Throughout my years in the industry evaluating investigation reports, I have found that many investigations do not clearly describe the nature of the nonconformance, i.e., the problem statement. Why is having a clearly defined and succinct problem statement so critical? Well, it can mean the difference between an effective investigation that identifies and eliminates the root cause of the nonconformance; and an ineffective investigation that identifies symptoms of a much larger problem and fails to identify the root cause.
In the former case, a clearly identified problem statement that describes the nature of the nonconformance is likened to an arrow hitting its targeted bulls’ eye every time. When you have clearly identified your problem, it helps to establish a laser-like focus in the investigation that is less likely to stray from the true intent of what is being investigated. A well-defined problem statement also helps guard against scope creep and facilitates the identification of the true root cause of the problem as opposed to addressing the symptom of the problem.
In the latter case, an ill-defined problem statement often leads the team astray as they focus their attention on various aspects of the problem that may not be relevant to the root cause. In such instances, the nonconformance is likely to reoccur requiring additional resources, time, effort, and energy in trying to resolve a matter that has not been clearly defined in the first place.
So, how do you ensure that you have drafted a clearly defined and concise problem statement? Well, you can begin by asking the following questions:
• What is the nonconformance that has been identified? E.g, product “X”
failed to meet its specification of “Y – Z”.
• When did the nonconformance occur?
• How was the nonconformance identified?
• At what point in the process was the nonconformance identified?
As you evaluate and begin to answer each question, it is important that you keep the focus on answering the specific question at hand and not attempt to offer any conclusions or potential causes at this point. In other words, your problem description should not say: “Product “X” failed to meet its specification of “Y – Z” due to operator error”. That is a conclusion that will be brought out during the course of the investigation and its validity either confirmed or eliminated with objective evidence.
Throughout my years in the industry evaluating investigation reports, I have found that many investigations do not clearly describe the nature of the nonconformance, i.e., the problem statement. Why is having a clearly defined and succinct problem statement so critical? Well, it can mean the difference between an effective investigation that identifies and eliminates the root cause of the nonconformance; and an ineffective investigation that identifies symptoms of a much larger problem and fails to identify the root cause.
In the former case, a clearly identified problem statement that describes the nature of the nonconformance is likened to an arrow hitting its targeted bulls’ eye every time. When you have clearly identified your problem, it helps to establish a laser-like focus in the investigation that is less likely to stray from the true intent of what is being investigated. A well-defined problem statement also helps guard against scope creep and facilitates the identification of the true root cause of the problem as opposed to addressing the symptom of the problem.
In the latter case, an ill-defined problem statement often leads the team astray as they focus their attention on various aspects of the problem that may not be relevant to the root cause. In such instances, the nonconformance is likely to reoccur requiring additional resources, time, effort, and energy in trying to resolve a matter that has not been clearly defined in the first place.
So, how do you ensure that you have drafted a clearly defined and concise problem statement? Well, you can begin by asking the following questions:
• What is the nonconformance that has been identified? E.g, product “X”
failed to meet its specification of “Y – Z”.
• When did the nonconformance occur?
• How was the nonconformance identified?
• At what point in the process was the nonconformance identified?
As you evaluate and begin to answer each question, it is important that you keep the focus on answering the specific question at hand and not attempt to offer any conclusions or potential causes at this point. In other words, your problem description should not say: “Product “X” failed to meet its specification of “Y – Z” due to operator error”. That is a conclusion that will be brought out during the course of the investigation and its validity either confirmed or eliminated with objective evidence.
Monday, August 3, 2009
Elements of a Thorough Investigation- Part 2
In last week’s blog, I discussed the importance of Documentation as one of the elements of a thorough investigation. In this blog, I will discuss the second aspect of a through Quality System or GMP investigation, and that is, determining the difference between people and process driven activities as they relate to a comprehensive investigation.
The distinction between “people and process” driven activities is an important one in that it directly impacts your ability to clearly identify the root cause of a nonconformance as well as identifying appropriate corrective actions.
Let me clarify. A process is a sequence of repeatable steps that lead to some desired end or output. When you have a clearly defined and documented process, the outcome is not dependent upon an individual “remembering” to carry it out. Any individual (provided that they have the proper “education, training, and experience, or any combination thereof”) can come into the environment and perform the activity as it is defined and reach the same outcome.
People driven activities on the other hand are:
- Often not documented
- Subject to variation in interpretation and execution
- Often play a crucial role in the identification of the root cause of the nonconformance
An activity that is “people driven” may or may not be reproducible, regardless of the “education, training, and experience, or any combination thereof” of the individual. An activity that solely relies on an individual’s memory to be successfully executed is often wrought with variation in how it is carried out resulting in significantly different outcomes. Such activities will often play a major role in the root cause of a nonconformance. That is, the individuals who are tasked with completing this activity may interpret the steps differently, or place different emphasis on such task and when it is necessary to carry them out.
Therefore, in investigating a nonconformance, you must determine whether the critical parameters are dependent upon the individual, i.e., “people” or a clearly defined “process”. You must still investigate each, regardless of the outcome, but the importance of this step is that it will provide you with an in-depth view of your process and take appropriate actions; i.e., to draft procedure for critical process parameters that are not well defined or documented.
The distinction between “people and process” driven activities is an important one in that it directly impacts your ability to clearly identify the root cause of a nonconformance as well as identifying appropriate corrective actions.
Let me clarify. A process is a sequence of repeatable steps that lead to some desired end or output. When you have a clearly defined and documented process, the outcome is not dependent upon an individual “remembering” to carry it out. Any individual (provided that they have the proper “education, training, and experience, or any combination thereof”) can come into the environment and perform the activity as it is defined and reach the same outcome.
People driven activities on the other hand are:
- Often not documented
- Subject to variation in interpretation and execution
- Often play a crucial role in the identification of the root cause of the nonconformance
An activity that is “people driven” may or may not be reproducible, regardless of the “education, training, and experience, or any combination thereof” of the individual. An activity that solely relies on an individual’s memory to be successfully executed is often wrought with variation in how it is carried out resulting in significantly different outcomes. Such activities will often play a major role in the root cause of a nonconformance. That is, the individuals who are tasked with completing this activity may interpret the steps differently, or place different emphasis on such task and when it is necessary to carry them out.
Therefore, in investigating a nonconformance, you must determine whether the critical parameters are dependent upon the individual, i.e., “people” or a clearly defined “process”. You must still investigate each, regardless of the outcome, but the importance of this step is that it will provide you with an in-depth view of your process and take appropriate actions; i.e., to draft procedure for critical process parameters that are not well defined or documented.
Thursday, July 30, 2009
Elements of a Thorough Investigation
Nonconformances are an inevitable part of any process. Whether it is in a manufacturing, production or laboratory environment, at some point, you will encounter an observation or result that is contrary to its pre-determined requirements or specifications. In such instances, some type of an investigation will be required. The subject of this week’s blog is to outline some of the elements of a thorough investigation that supports compliance to the regulations and provide some brief examples.
A comprehensive quality system or GMP investigation must be substantiated by documented evidence. Documentation provides the necessary objective evidence to support any claims or findings of the investigation. Documentation is what provides an investigator or auditor, the assurance that the claims that you are making in support of the root cause(s), or corrective action(s) are valid.
Documentation also serves as proof of what element or process or idea that has been eliminated as potential root causes. And in the eyes of an investigator, “if it is not documented, it’s a rumor”. Your investigation packet can contain all of the elements to show how the product was manufactured, packaged, or tested in a laboratory setting; but unless you can show via documented evidence the actions taken and relate those actions back to your investigation, then you do not have the necessary evidence required to support your claim.
What does documentation consist of and what sorts of actions require documentation? Well, Documentation consists of written records that guide activities and prove what has occurred. Documentation in support of an investigation must clearly demonstrate the actions that were taken, when they taken, who executed such actions, as well as the qualifications of such individual. If you recall, personnel qualifications is mandated by both the GMP and QS regulations. 21 CFR 211.25 states the following in regards to personnel qualification:
(a) "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them."
Next, the documentation to support your investigation must clearly show the sequence of events and conclude whether they confirm or eliminate a root cause. This can be easily accomplish by a heading or a brief footer that describes what this data support. It should not be left to the auditor to “guess” at what the data support. They may arrive at a different conclusion than you intended. Be upfront and clear at all times.
Finally, documentation of your corrective actions must not only comply with the points above but must also support your root cause. That is, the documentation that you are including as part of your investigation packet to support the validity of your corrective actions must clearly tie back to your root cause(s). If it does not, the investigation leaves the door open to potential causes that remain unexamined and the possibility that the given nonconformance may reoccur.
A comprehensive quality system or GMP investigation must be substantiated by documented evidence. Documentation provides the necessary objective evidence to support any claims or findings of the investigation. Documentation is what provides an investigator or auditor, the assurance that the claims that you are making in support of the root cause(s), or corrective action(s) are valid.
Documentation also serves as proof of what element or process or idea that has been eliminated as potential root causes. And in the eyes of an investigator, “if it is not documented, it’s a rumor”. Your investigation packet can contain all of the elements to show how the product was manufactured, packaged, or tested in a laboratory setting; but unless you can show via documented evidence the actions taken and relate those actions back to your investigation, then you do not have the necessary evidence required to support your claim.
What does documentation consist of and what sorts of actions require documentation? Well, Documentation consists of written records that guide activities and prove what has occurred. Documentation in support of an investigation must clearly demonstrate the actions that were taken, when they taken, who executed such actions, as well as the qualifications of such individual. If you recall, personnel qualifications is mandated by both the GMP and QS regulations. 21 CFR 211.25 states the following in regards to personnel qualification:
(a) "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them."
Next, the documentation to support your investigation must clearly show the sequence of events and conclude whether they confirm or eliminate a root cause. This can be easily accomplish by a heading or a brief footer that describes what this data support. It should not be left to the auditor to “guess” at what the data support. They may arrive at a different conclusion than you intended. Be upfront and clear at all times.
Finally, documentation of your corrective actions must not only comply with the points above but must also support your root cause. That is, the documentation that you are including as part of your investigation packet to support the validity of your corrective actions must clearly tie back to your root cause(s). If it does not, the investigation leaves the door open to potential causes that remain unexamined and the possibility that the given nonconformance may reoccur.
Tuesday, July 21, 2009
Is it really a Training Issue?
When it comes to identifying the root cause of a nonconformance, invariably, training will always be evaluated as a potential cause of the event. While I completely agree that training must always be evaluated as a potential root cause, I must caution the investigator to go further. Going further means not to accept at face value that training is the culprit in every nonconformance event. It means challenging the notion that “training” or “training effectiveness” played a role in the identified nonconformance. It also means having an established guideline / process for measuring training effectiveness within your organization.
Identifying the root cause of a nonconformance as a “training” issue happens very often in the investigation world with little to no supporting evidence to justify this position. I believe that many organizations sign off on these investigations for several reasons:
(1) It is an easy way out—many companies incorporate a 20-working day due date for the investigation which includes: identifying the problem, determining the root cause, evaluating trends, implementing corrective and preventive actions and monitoring for effectiveness of the actions. This extremely limited time period often forces well-meaning investigators and approvers to simply accept “training issue” as a rationale for the root cause of the event.
(2) Organizations do not have a pre-established guideline and/or process for measuring training effectiveness. The question of how does an organization measure training effectiveness is one that many shy away from. Is training effectiveness measured by simply reading the SOP? Is an instructor-lead training the best vehicle to execute training? Is an acknowledgement of “read and understood” for a given procedure equivalent in comprehension to an instructor-lead training?
Before you signoff on your investigation and accept the root cause of the nonconformance as being attributed to “training” or “training effectiveness”, be sure to:
*Evaluate all other potential root cause
*Perform a trend analysis to determine whether there is a trend that may require
Identifying the root cause of a nonconformance as a “training” issue happens very often in the investigation world with little to no supporting evidence to justify this position. I believe that many organizations sign off on these investigations for several reasons:
(1) It is an easy way out—many companies incorporate a 20-working day due date for the investigation which includes: identifying the problem, determining the root cause, evaluating trends, implementing corrective and preventive actions and monitoring for effectiveness of the actions. This extremely limited time period often forces well-meaning investigators and approvers to simply accept “training issue” as a rationale for the root cause of the event.
(2) Organizations do not have a pre-established guideline and/or process for measuring training effectiveness. The question of how does an organization measure training effectiveness is one that many shy away from. Is training effectiveness measured by simply reading the SOP? Is an instructor-lead training the best vehicle to execute training? Is an acknowledgement of “read and understood” for a given procedure equivalent in comprehension to an instructor-lead training?
Before you signoff on your investigation and accept the root cause of the nonconformance as being attributed to “training” or “training effectiveness”, be sure to:
*Evaluate all other potential root cause
*Perform a trend analysis to determine whether there is a trend that may require
further evaluation
*Evaluate your current training program to determine how training is disseminated
and the mechanism for evaluating effectivenessChallenge, challenge, challenge!
*Evaluate your current training program to determine how training is disseminated
and the mechanism for evaluating effectivenessChallenge, challenge, challenge!
Wednesday, July 8, 2009
Verifying or Validating CAPA
The topic of verifying or validating CAPA is a very important step in the investigation process and one that is often overlooked. Many investigations will adequately investigate the nonconformance, determine the root cause, may identify actions needed to correct and prevent the recurrence of the nonconformance, but will often fall short of the mark when it comes to the verifying or validating the corrective and preventive actions to ensure that the actions taken are effective.
Verification or validation of a corrective and preventive action is mandated by the quality system regulations as defined in 21CFR820.100 (a) (1) (4):
Verifying or validating the corrective and preventive action to ensure that
such action is effective and does not adversely affect the finished device;
What this means is that once you have clearly identified the actions that you need to take in order to correct and prevent this problem, you must take it one step further and verify or validate that the action(s) will in fact work to fix the issue at hand. Why is this an important step in the investigation process?
Well, first of all, investigations are to have what I like to call a “defined lifecycle”. By that I mean:
(1) Identify the nonconformance.
(2) Contain the nonconformance. That is, immediately identify how you are going to contain this nonconformance to ensure that nonconforming product does not enter the marketplace.
(3) Next, you will investigate the nonconformance to identify the root cause
(4) Identify and implement certain actions to correct the nonconformance
(5) Finally, you must validate or verify that those actions will work and will not adversely affect the product
This “defined lifecycle” is supposed to be part and parcel of a clearly defined process that will not only investigate the issue at hand, but also to ensure that when investigated correctly, you should not have a recurrence of this same issue. Hence, the importance of verification or validation of the actions identified in the investigation. Where there is no verification or validation that the actions will work, then the likelihood of a recurrence of this same issue is not only probable, but inevitable.
An investigation is supposed to be a finite event that leads you not only to identify the root cause, but whatever actions are taken should prevent a recurrence of the nonconformance. If it does not, then you can rest assured that there has been a break in the “defined lifecycle” and the nonconformance is likely to repeat itself.
Verification or validation of a corrective and preventive action is mandated by the quality system regulations as defined in 21CFR820.100 (a) (1) (4):
Verifying or validating the corrective and preventive action to ensure that
such action is effective and does not adversely affect the finished device;
What this means is that once you have clearly identified the actions that you need to take in order to correct and prevent this problem, you must take it one step further and verify or validate that the action(s) will in fact work to fix the issue at hand. Why is this an important step in the investigation process?
Well, first of all, investigations are to have what I like to call a “defined lifecycle”. By that I mean:
(1) Identify the nonconformance.
(2) Contain the nonconformance. That is, immediately identify how you are going to contain this nonconformance to ensure that nonconforming product does not enter the marketplace.
(3) Next, you will investigate the nonconformance to identify the root cause
(4) Identify and implement certain actions to correct the nonconformance
(5) Finally, you must validate or verify that those actions will work and will not adversely affect the product
This “defined lifecycle” is supposed to be part and parcel of a clearly defined process that will not only investigate the issue at hand, but also to ensure that when investigated correctly, you should not have a recurrence of this same issue. Hence, the importance of verification or validation of the actions identified in the investigation. Where there is no verification or validation that the actions will work, then the likelihood of a recurrence of this same issue is not only probable, but inevitable.
An investigation is supposed to be a finite event that leads you not only to identify the root cause, but whatever actions are taken should prevent a recurrence of the nonconformance. If it does not, then you can rest assured that there has been a break in the “defined lifecycle” and the nonconformance is likely to repeat itself.
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