Issue. Deviation. Quality Event. Nonconformance.
These are all terms used to identify a situation in a pharmaceutical manufacturing facility where something didn’t go as planned. In the absence of a well-managed, robust process, the numbers of these events can spiral out of control—sometimes, it feels like the numbers double overnight. And when issues start to exceed the capacity of the organization to address and close them, a backlog is created. This backlog puts a strain on the organization’s resources and must be dealt with quickly to prevent it from getting out of control.
CAPA Plan Implementation Process
The process for addressing these issues usually follows this path:
1. Open issue/event creation – this is a description of what happened, and includes who, what, where, when, and possibly why.
2. Assessment of severity – this is an assessment of risk to the patient, quality of the product, quality of the data, and other factors. Some companies have 2 levels (minor and major), while others have 3 (minor, moderate, and major).
3. Root cause analysis (RCA) – this is the process of discovering root causes of problems to identify appropriate solutions to prevent the same event from occurring in the future. Common tools used here are the five whys, fishbone/6M (man, method, machine, mother nature, measurement, and material), causal factors charting, and fault tree analyses.
4. Development of Corrective and Preventative Actions (CAPA) – this is determining which actions to take to prevent future occurrences of the event in question (or similar ones in other areas). The extent and implementation timing of each action is determined following an evaluation of the frequency of occurrence of the identified root cause and the impact of the issue.
5. Review/approval of RCA and CAPA plan – a team of resource owners and technical experts typically approve the RCA and CAPA plan.
6. CAPA plan implementation– this is the full execution of the plan.
7. CAPA plan effectiveness evaluation– the organization must allow enough time for the plan to be implemented and to take effect while maintaining a sense of urgency around ensuring that the root cause is addressed and will not occur again. It is important to note that some CAPA actions can be implemented and assessed very quickly, while others may spread out over several months. Organizations often have time frames/metrics around CAPA implementation and effectiveness checks that consider the complexity and urgency of the CAPA plan.
Having a deviation/CAPA program that is in control is a right to operate, meaning it is a baseline expectation of regulatory bodies when it comes to pharmaceutical manufacturing. If your deviation/CAPA program appears to be out of control, you can expect increased scrutiny into your quality management systems. When your organization finds itself with a large and growing backlog of events, it is extremely important to find your way out of it as quickly as possible.
Addressing Backlogged Events
So, how do you recover? We recommend addressing the issue on several fronts:
1. Beg, borrow, buy additional resources to address the events in the backlog. This is a brute force approach to reducing backlog quickly but can be effective if the resources that approve the RCA/CAPA Plans can keep pace with the additional resources that are assessing and doing RCA.
2. Perform an RCA on why your deviation/CAPA program is not producing the desired results. Examples include:
· Turnover
· New processes being implemented
· High rate of change to existing processes
· Overly complex processes
· Equipment issues
· A fragile, unrobust, or overly complex RCA/CAPA process
3. Assess your CAPA plans. The following are examples of critical questions to ask during this assessment:
Are the organization’s root cause investigations not finding actual root cause, leading to CAPAs which don’t really address the issues?
Are most events being labeled as some form of human error?
Does the organization find many CAPAs that start with “update procedure to…” or “retrain staff to...” or “provide communication to staff to…” which means that it may be dealing with an ineffective training program or overly complex systems for the frontline staff to navigate?
Do you have a backlog of CAPAs, which leads to recurrence of events with the same root cause?
Do you see actual reduction in the number of events issued based on the number of CAPAs implemented? If your deviation rate is increasing or remaining flat over time while multiple CAPAs are implemented, then the organization may need to take a hard look at its effectiveness evaluations.
The Road to Recovery
Let’s look at each phase of recovery. Ideally, the organization should work on all three simultaneously, but based on resources, that may not be possible.
1. For working through the backlog of items (deviations or CAPAs), it is recommended to prioritize the closure based on risk. If internal resources are available, this can save time and costs involved with training and getting external resources up to speed on the deviation process. However, many times, external resources are required to provide the necessary numbers of people to gather information and address the issues. This may be an indicator that the organization is understaffed—which may be a key contributor to the creation of the backlog.
2. How did we get here? When analyzing the event/deviation process, it is helpful to analyze data showing where substantial time is spent and where rework occurs. Once you have trouble points identified, study the reasons, and adjust. This is where the hard work comes into play—critically analyze what your resources are doing and determine if it adds value. Some important questions to consider are:
Is the organization adding new products/overhauling existing ones, and this increasing reoccurrence rate?
Have they downsized significantly from the past?
Has there been a large turnover in staffing? Has there been a significant change in quality standards?
Are the technical resources doing activities such as filing documents that could be delegated to someone else?
If rework is occurring, why?
For all of these, it will be necessary to understand details. Many times, it all starts with the quality of the information documented at the time of deviation occurrence. This allows for a timely assessment of the severity of the deviation. Once the assessment is made, getting information to RCA leader or team is also imperative to meet timelines.
3. Are the CAPA plans effective at reducing or eliminating deviations? A critical judgment of the effectiveness of the CAPAs should be done. Note that you should err on the side of engineering controls to eliminate or reduce the opportunity for deviations....so cite a couple examples. Administrative controls should be used sparingly as long term solutions—however, they may be appropriate as an interim solution. Just remember to remove them when the engineering solution is in place! Use caution when implementing a CAPA plan when you have not determined a definitive root cause. You may be adding layers of complexity that are not needed and will cause different deviations in the future.
How Can We Help?
As a leader in deviation/CAPA support, Process Alliance enables our clients to better navigate situations where something didn’t go as planned, and to de-risk their manufacturing processes. To learn more about how our experts can help streamline your deviation/CAPA program, email us at pa.info@pa-engineering.com, or visit our website.