In life science companies, corrective and preventative actions (CAPAs) are really important.\u00a0 They are the things you do to ensure product safety, quality and consistency, appease regulators and save lives.\u00a0 Not all CAPAs are effective though \u2013 some aren\u2019t well thought through, others are implemented poorly, and some actions fail to yield the intended impact after some time has passed.\u00a0 If your company is experiencing any of these situations, perhaps its not the CAPAs themselves which are the problem \u2013 maybe its your company culture.<\/p>\n
Many people think of CAPAs as something that is driven by regulators and recalls \u2013 something you are forced to do.\u00a0 A better way of looking at CAPAs is as a tool for continuous improvement.\u00a0 No company is perfect \u2013 there are always risks and opportunities to make things better.\u00a0 The question to ask yourself is this\u2026 if it weren\u2019t for regulators (and customers) mandating it, would your employees still seek out continuous improvement opportunities and pursue corrective and preventative actions?\u00a0 Or would they just focus on executing the processes as they exist today?<\/p>\n
CAPAs are not one-time fixes that can then be ignored.\u00a0 They are changes to the processes, behaviors and activities that your company executes.\u00a0 The CAPA process isn\u2019t cheap \u2013 there are many hours invested in analyzing operations, identifying root causes of issues and developing response plans.\u00a0 But the real benefit isn\u2019t realized until the actions are taken and the outputs of your production processes change.\u00a0 Does your company have a process to go back and review the effectiveness of CAPAs a few months after implementation?\u00a0 Or to build CAPA related measures into your operational monitoring processes?\u00a0 If not (or if you don\u2019t know), it means you may be experiencing a \u201cfix and forget\u201d phenomenon and not really achieving the long term benefits you need from CAPA investments.<\/p>\n
Individuals in your organization (for the most part) will adapt to the culture and expectations set by their direct managers and the HR processes used to evaluate their performance.\u00a0 If you think you might have a problem with CAPA performance, this is a good place to start.\u00a0 What behaviors are you incentivizing through your performance review process and compensation plans.\u00a0 Are employees measured on production volume?\u00a0 Product quality? If they were to come up with an idea for how to make operations better, how would this be received and rewarded by the company?<\/p>\n
Employees naturally have intrinsic motivation to make their environment better unless that motivation is somehow undermined by an outside source.\u00a0 Many companies take the attitude that there is a group of employees paid to produce and a different group of employees paid to improve operations.\u00a0 This philosophy ends up being counter-productive as it decreases the motivation of the first group and decreases the effectiveness of the second.<\/p>\n
A healthy continuous improvement culture (that will lead to CAPA effectiveness) starts with enabling and empowering employees (regardless of where they are in the company) to identify opportunities and take actions to make their environment better.\u00a0 Management and HR processes can encourage this behavior by providing time for employees to come up with improvement ideas, support for implementing them, and rewards (it may just be acknowledgement) for the impact that these ideas yield over a period of time.<\/p>\n