How to implement a robust Quality Risk Management Program
Human error is a long standing problem in the pharmaceutical industry. The industry has built in corner stones into its Quality Management Systems to catch human error and prevent any defective medicines from reaching the patient. Batch record review and testing of materials throughout the production process are to name but a few of these quality systems. Ultimately, however, this does ensure patients receive safe medicine. Human error is a consistent problem for the industry and adds indirectly to the cost of medicines. Human error often leads to a rejection, rework or re-process of product. Even in cases where the error is considered minor, the deviation will lead to detailed investigation and testing to verify that it is not significant. As the pharmaceutical industry evolves to more complex medicines, this additional testing is often not practical, which heightens the likelihood of going for the failsafe option of material rejection. Here are some fresh approaches to consider: Dig a little deeper into Investigations When carrying out an investigation, root causes for human error can typically be: procedure inadequate, training inadequate or absence of a second check. These may be genuine intermediate reasons for the human error, however, companies need to dig a little deeper to really tackle this issue. While these are valid intermediate root causes, they need further analysis to arrive at a truly effective CAPA. At this point, it is important to add another layer to the root cause investigation. This can be done, for example, by applying the 5-Why technique again starting with the intermediate root cause.
- Human Error?
- Accidental – why?
- Application of a bad practice for the right reason- why?
- Wrong tool/ equipment-why?
- Improvisation in unfamiliar circumstances-why?
- Omitting, forgetting or losing place-why?
- Distracted at a critical point-why?
- Incorrect assumption or perception-why?
- Common practice not to follow procedure for that step-why?
- Lack of appreciation on importance of following procedure-why?
By continuing to ask ‘why’, valuable CAPAs will emerge from the process. For the example above, the root cause will not just be human error and examples of effective CAPAs can be deduced. Improved Communication Strategies
- Changeover of shifts is a higher risk time for any facility and can increase the likelihood of human error if they are not executed properly. Identify higher risk handovers; develop staff’s communication skills; emphasise the importance of shift handover and provide procedures for shift handover.
- Take cue from other industries, for example, the aviation industry. Many operations require two people for execution. In these cases, an error prevention mechanism worth considering is that one person gives the instruction and the other repeats and executes that instruction. The benefit of repeating and confirming instructions create clarity and avoids confusion.
Competence of the Team It needs to be ensured that personnel have the appropriate abilities, commitments, knowledge, and skills that enable a person (or an organisation) to act effectively in a job or situation. To improve your team’s competence, consider:
- Improved change management
- Review training or include refresher training
- Consider if a mentoring system is required
- Ensure procedures are in place to handle complex situations
- Supervision of key activities
Mistake Proof the Organisation’s Processes Mistake-proofing or its Japanese equivalent poka-yoke (pronounced PO-ka yo-KAY), is the use of any automatic device or method that either makes it impossible for an error to occur or makes the error immediately obvious once it has occurred. Poka-yoke can be implemented at any step of a manufacturing process where something can go wrong or an error can be made. While errors are inevitable in any manufacturing process, if appropriate poka-yokes are implemented, mistakes can be caught quickly and prevented from resulting in defects. Examples include:
- Labelling and Colour coding
- Removal of distractions for complex work tasks.
- Use of an automatic device that makes it impossible for an error
Culture programmes Programmes such as leadership programmes, positive behaviour programmes and performance programmes can help instil a no-blame culture where personnel take ownership of quality. The elimination of blame from your organisation can be a complex and slow process. However, when the organisation’s leaders focus on values, behaviours and processes, blame based behaviours will lessen over time. The change in culture will greatly improve the trust amongst team members and the team can focus on improving organisational processes to eliminate human error.
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