Author: Ann McGee, managing director, McGee Pharma International Human error frequently occurs in pharmaceutical manufacturing, even when the organisation considers that it has done everything to prevent its occurrence. Documentation appears accurate, personnel are fully trained and equipment operates as designed, but errors continue to be made. In many organisations, human error is assigned as the root cause of the event, with reasons given such as ‘lack of attention to detail’ or ‘failure to follow procedure’. Corrective action will involve re-training or disciplinary action. Such approaches do not seek to understand why the error(s) occurred and they certainly cannot be expected to prevent re-occurrence. In this article, we look at the common causes of human error in pharmaceutical manufacturing and outline an approach to reducing these errors, with an objective to offer an insight into the common causes of human error in the area of pharmaceutical manufacturing and to provide a defined approach to investigating risk-influencing factors (RIFs) and root cause, reducing human error and sustaining error reduction within companies. [login type="readmore"] DEFING HUMAN ERROR So, what is human error and why is its impact so important for pharmaceutical manufacture? An error is a deviation from accuracy or correctness. ‘Human error’ is a mistake made by a person rather than a machine, states the Oxford English Dictionary. According to Dr Kevin O’Donnell (Irish Medicines Board, 2009), “Human error is frequently cited as a primary cause of quality defect issues that have led to batch recalls”. Indeed, as Dr O’Donnell highlighted at the PharmaChem Skillsnet & PharmaChemical Ireland Conference in Cork in December 2009, the Irish Medicines Board (IMB) has reported that 25% of all quality defects – such as deviations, laboratory errors, complaints and inspection issues – are attributed to human error. These include:

• Failing to follow procedures correctly;
• Using technical dossiers to support batch releases that do not correctly reflect the contents of the marketing authorisation;
• Poor line clearance, resulting in rogues being left on a processing line;
• Failing to implement variations following their approval by the competent authority.

In the same presentation, Dr O’Donnell outlined that the IMB has reported that 90% of recalls relating to packaging and labeling are attributed to human error and that quality defects are often attributed to human error without scientific evidence. John Evans, managing director of HEB and leading expert on human error, identifies two main types of RIF for human error. These are stressor RIFs (pressure causing a feeling of stress) and structural RIFs (inherent weakness in activity). RIFs can be grouped into ‘families’ of issues that might affect the risk of human error, e.g. process, information, resource, competence, organisation and stressors (PIRCOS). Stressor RIFs increase the probability of human error. They are often temporary but may re-occur, i.e. if they are caused by fatigue or very tight work deadlines. Therefore, they are subjective as they depend on the person within the team making an error. They also; however, expose structural vulnerability, which will need further investigation. Structural RIFs are relatively persistent in nature but are often not immediately obvious, unless triggered by stressors. Structural RIFs occur across a company and can be caused in any one of a number of areas: for example, processes where several concurrent activities are competing for attention; information giving (poor layout of batch manufacturing record); resource characteristics such as environmental conditions causing distraction; and organisational planning, including when shift arrangements undermine vigilance. It is important that realistic demands are placed on employees as work overload/concurrent conduct of tasks leads to mistakes. Other factors to take into consideration when identifying RIFs include an individual’s capacity and the effect of sleep deprivation/stress/emotional upset. LEADERSHIP & TEAMWORK To ensure a true understanding of human error and its contributor factors, a strategic approach should be taken. It is extremely important to create awareness and understanding of risks in an organisation by analysing its processes and understanding human error risks. To do this, a QRM (quality risk management) approach is recommended, which includes risk assessment, risk control, risk review and risk communication. It must also include routine tracking, evaluation and analysis of human error metrics. While it is advisable to proactively assess potential risks, situations occur where retrospective analysis is necessary. There are a number of key activities that should be undertaken in each situation. For retrospective risk identification, you will need to identify how and where in the process human error is likely to occur through the use of a scientific approach:

• Review process flow and information flow;
• Identify the RIFs;
• Identify the issues with which RIFs are commonly associated (PIRCOS);
• Plan your processes to minimise and control these risks.

For retrospective analysis, you will need to capture the event in real time, taking note of environmental and other factors that may be relevant to a thorough evaluation of the issue. You will also need to consider the level of the RIF effect:

• Individual – affects a single individual;
• Local – within a limited physical area, relevant to specific activity, affects a finite number of people;
• Generic – this could be common, where the risks are shared across numerous instances of a common problem (e.g. misreading a table in a document used widely in the company); or independent, where there are several risks in different parts of an organisation (e.g. misreading a typeface used in numerous documents only used locally).

Then you should analyse whether your con-compliances associated with human error can provide further insight (e.g. from QMS, deviations and CAPA complaints management system software). There are number of root-cause analysis (RCA) tools and techniques that can be used, such as brainstorming sessions, fishbone diagrams, ‘five whys’ and fault-tree analysis. ENHANCING HUMAN RELIABILITY In order to design and manage operations with human error in mind, an ‘open communication’ environment is essential. It is important to include the following key factors to support all of the team to achieve a reduction in human error:

• Do not assume that the cause of a quality defect is human error;
• Shift from a retrospective and superficial evaluation of human error to a prospective, risk-based evaluation of critical processes and procedures;
• Investigate and identify true contributory causes – use a team-based and science-based approach;
• Motivate your people to embrace human error identification through recognition and support;
• Be aware of limitations – risk factors can be outside of conscious control;
• Create an atmosphere of accountability by displacement of blame;
• Give and take feedback;
• Empower personnel to address their own RIFs;
• Adopt a continuous improvement process – involve staff at all levels and introduce a core risk-reduction team who develop a body of knowledge; and
• Support innovation and understanding.

In summary, be clear as to what constitutes human error. Use a risk-based approach to identify the RIFs for critical processes and design to minimise human error potential. Apply a QRM approach to sustaining low levels of human error and to promoting a working environment that supports a proactive approach to minimising the potential for human error. Ann McGee, managing director of McGee Pharma International, has over 30 years' experience, divided between the pharmaceutical industry, as a regulator and a pharmaceutical consultant. Her industrial experience spans the areas of clinical trials, regulatory affairs, product development, compliance, technical management and as a 'qualified person'. As a regulator, McGee worked as a senior inspector with the Irish Medicines Board and inspected nationally and internationally on behalf of the European Medicines Agency for GxP compliance. She also acted as registrar and secretary (CEO) of the Pharmaceutical Society of Ireland. References Human Error & Re-training – Issues to consider during deviation and complaint investigations. Kevin O’Donnell PhD, Market Compliance Manager, Irish Medicines Board  (December 2009) 'Human Error Seminar' - Ann McGee and John Evans (May 2010)