Pharmacy Courses

How to Manage and Prevent Human Error in FDA Regulated Industry

Genuine human errors do happen, but they’re cited far more frequently than they should be. 

In truth, most problems that appear to be caused by human error - those that occur multiple times are actually rooted in processes or systems that when left unchanged, will keep producing the problem despite the convenient band-aids often placed over them. 

When human error is identified more frequently than it should be expected to happen, it signals to investigators that problems aren’t being investigated thoroughly enough, thereby shifting them into problem-hunting mode and opening your quality management system up to even greater scrutiny.

For example, while using the Ishikawa Diagram for the RCA, the team classifies all the probable root causes into the 5M categories as a starting point.  These categories are often labeled as Manpower, Material, Method, Machine, Measurement, and Miscellaneous causes. 

Out of these five categories, the Manpower related root causes are the most debated ones as regrettably, this category is exploited as a scapegoat under the label of ‘human error’. 

The same can be true for other RCA techniques when the team lands on a probable root cause as ‘human error’ during the investigation process. 

Landing on a human error as the root cause too often is undesirable as it starts a never-ending passing-the-buck game that spoils your company’s quality culture, and at worst, the real issues remain unaddressed resulting in multiple recurrences. 

In FDA regulated manufacturing, you are not only expected to point towards causes but also eliminate them through proper Corrective and Preventive Actions.

It is essential to objectively investigate the causes labeled as human error using human factors engineering and cognitive psychology models such as the Skills, Rules, Knowledge (SRK) framework. It is used to understand how people perform tasks and make conclusive decisions.

Skills (S):

Skills refer to actions that are performed automatically and without conscious thought. These are tasks that have been practiced to the point where they become almost instinctive.

Rules (R):

Rules are decision-making processes based on explicit guidelines or protocols. When a situation is recognized, specific rules are applied to determine the appropriate action.

Knowledge (K):

Knowledge represents understanding and problem-solving ability. It involves the application of general principles and strategies to solve new or unfamiliar problems.

The solution is to build a quality culture by creating an effective CAPA Plan rather than avoiding it and digging deeper into the problem and identifying a superficial root cause with no Corrective and Preventive Actions. 

Most importantly, labeling the root cause as human error doesn’t put an end to the story, it is where the story begins.  Our responsibility is to create a robust system that doesn’t let ‘human error’ occur in the first place.

According to our understanding of the cognitive root cause, we can implement different problem solving strategies.

Errors that are shown to be “inadvertent” can be considered genuinely “human”, which then fall into one of three categories: 

  • skill-based, 
  • rule-based
  • knowledge-based mistakes.

Skill-based errors often occur due to momentary inattention or temporary memory loss, leading to slips or lapses. By addressing distractions and improving focus, we can reduce these errors.

Knowledge-based errors arise when individuals are overwhelmed by multitasking or lacking focus. 

To mitigate these errors, we need to ask: 

  • Why is multitasking happening? 
  • Are the departments under-resourced? 
  • Is there a lack of awareness of an individual’s workload?

Rule-based errors often result from misapplication of rules or procedures. To address these, it’s crucial to ensure adequate training and detailed, clear standard operating procedures (SOPs). 

If training falls short, we must examine why it’s failing to prepare individuals for their tasks.

Systemic issues in documentation can also contribute to errors. Streamlining documentation processes, ensuring up-to-date SOPs, and making them easily accessible can significantly reduce errors.

Once more, it’s important to note that these type of errors should not be happening frequently. 

The vast majority of problems that appear to be human error at first should lead you elsewhere upon further analysis.

Errors shown to fall into one of the two other categories (Human nature/Failure and Deliberate) should be viewed through a different lens. 

In these situations, processes—particularly related to training and oversight should be scrutinized as contributors.

Action Items

  • Conduct an objective assessment of your internal problem-solving processes (ideally with the help of an experienced third party) and remediate accordingly.
  • Replace metrics that establish problematic incentives with goals focused on long-term trending.
  • Explore ways to improve problem-solving within your QMS to reduce backlogs while thoroughly investigating issues.

Read also:
Previous Post Next Post