Human errors plays a major role in the violation of GMP and can lead to the deviation in different stages of manufacturing. Human errors have major or critical impact on products and may lead to the Data Integrity however due to various reasons human errors can occur which we have discussed in the earlier Topic.
In this Topic I have identified some ways by which we can reduce Human Errors (but not limited to)
Training plays a major role to reduce human error so when a person is joined in any organization it is the responsibility of his/her department Head and Quality assurance to provide him or her required training based on Experience and Qualification before assign him/her any work. The department head or Quality assurance should evaluate him/her by asking various questions related to Standard SOP procedure and job related things to get confident that the person can do the work and don’t leave the person along i.e assign any experienced or responsible person to keep watch on his/her and to guide him/her. Irrespective of designation and nature of work on job Training, cGMP, HR related training, Safety and Personal Hygienic & basic QA SOP training is required to everybody those who are working in pharmaceutical i.e Contract work men, freshers, Experienced and Senior persons. Organization to Organization systems are different so Training is required for Experience persons also. In case of any incidents or deviation or event or Compliant the root cause and the related Corrective and Preventive action (CAPA) shall be informed to all the the persons those who are involved in the operation or activities.
Communication plays an important role in the reduction of human errors. Communication among all the departments is very necessary for smooth functioning of any organization hence good communication ( mail, oral and written) is required between Quality Assurance to other departments (Production, Quality Control, warehouse and Engineering) at every stage. As you know that organization is running in different shifts (First, Second and Third shift) so during shift handover communication is very important and before leaving the organization charge handover is must required. we can improve by introducing Daily report for each Shift persons and they have to clearly mention the status of their respective areas so that it will become useful to next shift persons to know the status and to plan their next activities. Good communication is also required between Quality Assurance and Corporate Quality assurance.
Workload can play an important role in the reduction of human errors. If a person is involve in multiple activities or work continuously without rest due to some reason then he/she might can do the mistake and in order to avoid such we have to take some precautions. If required tasks or the work can be redistributed between team members or shifts or Head of Department can Assess the balance of workload across a shift and Experienced operators may be able to utilize for handling high task demands whereas inexperienced staff may be less able to handle the situation or work. Task analysis should consider both physical and mental workload. Ensure that workload assessment considers visual inputs (eg scanning display screens, looking out of windscreens, CCTV) and Set clear roles and responsibilities by ensuing that staff are clear on their priorities which will help to ensure that even when workload is high, staff are able to focus on key activities.
Performance of the individual personnel should be monitored by his/her Department head or supervisors and job should be assigned to their Education Qualification and work Experience or based on capabilities which can give better results in reducing human errors at workplace. Every time you assign a job and find out the person who is best to perform the particular task or work and if required we can change the job assignment of the persons based on performance to reduce the human errors.
The main way to reduce accidents caused by human errors is to redesign the job task or the Procedures. A simply designed job will reduce confusion, stress and mistakes are less likely to occur. Procedures are very important and should be well trained to the workers which should be clear, precise, and easy to read. They should be in easily understandable manner by the workers. For Example we can simplify the our Standard Operating Procedure (SOP) which are difficult to understand or can change in formats those are lengthy or difficult to follow by the users. We should try to made our Instruction (SOP, Batch records, Standard test procedures, General test procedure) very clear and short and precise for better understanding for the users. we can modify the complex or confusing instructions or if required you can display the confusing or complex things by using flowchart at the workplace or make a list of such things and inform to all the users in order to reduce errors.
As we know that organization working culture and Environment plays an important role in the mind of the employee working in the particular organization. So in order to reduce human errors positive work culture is required at work place which includes Providing support for one another, including offering kindness and compassion when others are struggling, Avoiding blame and forgive mistakes, Inspiring one another at work and Treating one another with respect, gratitude, trust, and integrity.
Equipment design plays an important role in reducing human errors and due to the manual system person can make mistake in Manufacturing, Quality Control and packing area so in order to overcome from this problem. we should adopt the automated system and should not bypass the system and if required we can fix camera in some areas where critical activities are going on to monitor the entire system and thus can reduce the human errors.
Senior managements or organizational factors plays an important role in reducing the human errors and management should involve in the problem which are facing by the employee i.e in some organization management is forcing to the employee to do some works which is not as per the procedure and in latter stage it can create a violation to the system or procedure and can be considered as human error so such types of things are thoroughly investigated and alternate solution to be adopted in order to reduce the human errors.
9. Cross Verification of the Activity :
Cross Verification of the activity plays an important role is reducing the human errors i.e doers can make mistake so his/her works shall be checked by his senior and same shall be cross verified by Quality Assurance to reducing the errors. If required some critical activities shall be crossed verified by senior persons to reduce the human errors.