CAPA a necessary evil or a useful tool for promoting Corporate Creativity?

Credit: J. Jariwala, Compliance Officer, FDA CDRH (2013)

This blog will explore the use of CAPA as a creative/innovation tool in a business setting. We are first going to look at the background of CAPA, what it is, how it developed, how it is traditionally used, how it can be utilised for innovation, and the benefits and the drawbacks of CAPA as an innovation tool.

What is CAPA?

Corrective and Preventive Action or CAPA is a well known quality control and risk analysis procedure that has its origins in the pharmaceutical and medical device industries that has now been widely adopted across a number of sectors due to its inclusion in the ISO 9000 series.

The process is focussed on identifying, investigating, understanding, and the correction of non-conformities with the aim on ensuring that these do not reoccur.

The definition of CAPA is varies depending on the application with the main differences being the FDA GMP (Good Manufacturing Practice) application and the more generally used ISO application.

The FDA describes for GMP purposes CAPA as a single process which consists of three separate steps; Firstly, taking remedial action to correct the identified problem, secondly, performing a root cause analysis to understand the cause of the non-conformity, and finally, taking a preventative action to prevent the non-conformity recurring. (FDA, 2006)

The ISO application, used in the 9000 series and 13845 – Manufacture of Medical Devices amongst other quality management systems, separates CAPA in to two separate distinct processes:

Corrective Action – Under the ISO standards a corrective action is essentially the three-step process as per the GMP application above, i.e., Action taken to eliminate and understand an existing non-conformity and taking action to prevent this event from recurring.

Preventive Action – Under the ISO standards a preventive action is taken to reduce the risk of a potential non-conformity occurring prior to it happening. (ISO, 2016)

For the purposes of this blog, I am going to focus on the ISO application of CAPA as it has multisector applications and thus is more likely to be of interest to my readers.

How CAPA is traditionally utilised in a Quality Management System

For the most part the maintenance of the quality management system and in turn the CAPA process has traditionally the undertaken by quality control team or business risk team within companies.

Source: Blue Ocean Data Solutions (n,d.)

This has led to very process driven CAPA application With the CAPA process predominately being seen as a “quality” issue only.

Figure 2. outlines some of the major shortcomings of traditional application of CAPA in businesses. A number of the shortcomings identified, disconnected process, information not being shared, and poor reporting of non-compliance can potentially be attributed to a lack of communication from the quality team and a feeling of procedures being pushed down on staff. Issues such as lack of oversight and tedious paperwork loads could potentially stem from a lack of knowledge and understanding of the processes involved in the front end of the business by the quality control team and the vice versa a lack of understanding from the management of the requirements and the need for CAPA in the quality management system.

How CAPA Process can be Amended to Improve Creativity

In figure 3 below I have outlined a basic CAPA process flow chart from initiation of the CAPA process be that from a non-conformity issue or a proactive preventive action.  

The flow chart in appearance isn’t very distant from the flow chart that you would expect to see in a quality manual of a traditional CAPA model. The key differential for using CAPA as a creative tool for process improvement is the involvement of staff from departments other than solely those from the quality team in the CAPA process. By allowing multidisciplinary involvement in some or all of the stages of the process it can lead to creative and inventive solutions that would have escaped the traditional method. Involvement in key stages such as root cause analysis, planned action or solution, validation, and implementation can transform the solution from being the quality only route of the past to a potentially easier to implement and manage on a day-to-day basis solution.

A relatively simple example from past experience, a non-conformity was identified in a warehouse regarding the procedure of calibrating the thermometers, a recalibration date was missed on an overflow warehouse that was not ordinarily in use, a process that was implemented a long time prior by the quality team as it was the normal procedure when they initially started off in quality control to self-calibrate. However, when the multidisciplinary team met a member of the warehouse staff suggested a solution that he had come across in a previous role, third party calibrated thermometers on a subscription model where new calibrated thermometers would be shipped 30 days prior to expiration of calibration certificate. Although a slightly more expensive solution it cut the paperwork involved for the quality team and removed the risk of the non-conformity recurring.

The Benefits of CAPA as a Corporate Creativity Tool

• The use of a multidisciplinary team to find a solution to solve a non-conformity or to prevent a potential non conformity from occurring allows for innovative solutions that not only help ensure conformity going forward but also can lead to overall process improvement.
• The inclusion of multi discipline staff members can lead to improved employee morale, especially relevant to the manufacturing sector, as employees feel like they have had their say in the moulding of the new procedures rather than being dictated to.
• It can lead to cost savings on new processes as cost and efficiency are not always at the forefront of quality and risk team decisions. Input from other staff members can help formulate a solution that best suits the resources available to the company be that staffing or equipment etc.

The Drawbacks of CAPA as a Corporate Creativity Tool

• As CAPA is an element of a quality management system and thus has recording requirements that other corporate creativity tools may not have it is not always the best tool for implementing corporate creativity.
• It can be a paperwork intensive process; this has the potential to lead to confusion and annoyance amongst the non-quality team members involved in the process who may be seeking a speedy resolution to the issue.

My Experience Of CAPA

Having a number of years’ experience in both the pharmaceutical industry, in a commercial role so I would be more familiar with GDP (Good Distribution Practice) than GMP, and the medical device industry where I have held roles in both the commercial team and the quality assurance team at a manufacturing site, I have been both the victim and the culprit of the shortcomings of the traditional CAPA model where control of process changes solely lies with the quality team.

I often found myself frustrated by process or standard operating procedure changes (SOP) that often led to an increased workload for us in the front office that were clearly developed to plug a non conformity but didn’t really consider the practicality of the change on the day to day running of the business. Ironically though, later when I was in a quality assurance role, I fell in to the same trap by taking a decision on a process change solely based on the quality control aspect as our team for CAPA was solely from the quality and risk departments.

In more recent times our company has evolved our CAPA process and other quality management processes, such as change control, to be more multidisciplinary often involving staff from every department from factory floor to the CEO or other senior management with the makeup of the team varying depending on if it was a corrective action or preventive action and the severity of the non-conformity.

From my experience using a multidisciplinary team was advantageous over using the traditional model of CAPA being solely conducted by the quality team. However, sometimes it did lead to heated debate between the quality team and the other members of the CAPA team weighing risk and compliance issues with the need for a practical implementation for the people operating the tasks on a day-to-day basis.

Not only did I find that it led to quicker implementation, as management were involved in the process their oversight or approval was easier to obtain it also resulted in improved tracking and trending of implemented solutions as there was buy in from across all departments as they were involved in the process change from start to finish.

As the multidisciplinary CAPA process evolved within the company it actually led to a greater number of non-conformities and potential non-conformities being reported to the quality team rather than them being identified during an audit etc., more often than not with potential solutions as staff members had seen that they were listened to in the past when in CAPA process meetings so felt that they would be listened to again.

The evolution of our company’s CAPA processes from what it looked like from the outside as a necessary evil or tick box quality control exercise to an inclusive multidisciplinary creative process enabled us to make changes and develop new projects that we would have otherwise not been capable of identifying and as such would advise that if you are reading this and your company is using a more traditional CAPA model that you should encourage them to transition to a creative multidisciplinary process to reap the benefits that it has to offer.

References:

ISO (2016) ISO 13845 2016. Available at: http://www.isomcx.com/uploadfile/2018/0623/20180623095340510.pdf (Accessed 06 April 2021)

FDA (2006) Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations 2006. Available at: https://www.inspiredpharma.com/wp-content/uploads/2012/02/fda-quality-systems-gmp-guidance.pdf (Accessed 08 April 2021)

Blue Ocean Data Solutions (n,d.) CAPA Available at: https://www.blueoceands.com/capa/ (Accessed 06 April 2021)

ExtraView (n,d) Life Sciences CAPA  Available at: https://www.extraview.com/site/content/life-sciences-capa (Accessed 06 April 2021)