Skills audit process

They must have the proper demeanor to conduct audits of this type. The audit process is evaluating systems and working processes, as carried out by people. Management systems auditors need excellent people, listening, and time management skills. 

The traditional audit may still be useful in that it leads one in the direction of identifying a faulty system or process, and if one chooses one can go further. Using the innovative approach offered by the quality assessment has some limitations in that it is not the current approach used during pharmaceutical and biotech inspections. Mock FDA audits should be used on a routine basis to ensure employees communication skills are sharpened and that the facility is inspection-ready. Preparation for an FDA inspection should begin during product development. It is a continuous process of the QAP, which the company should implement as early as phase I. No amount of resources in the last weeks before an inspection can make up for lack of adequate planning and preparation. 

The interview is at the heart of most audits (interview skills were discussed earlier in this chapter). The auditor systematically works through a series of questions with one or more of the people who work at the site. Typically, the process follows these steps ... 

Those individuals who are selected to perform audits or inspections should be qualified by having previous work experience in that area. They should also be trained and educated on the company s audit approach and the use of its audit instruments. The auditor must understand the technical aspects of operations and be familiar with all job procedures, manufacturing processes, and company policies. The individual(s) who perform the inspection should have good problan-solving skills and possess investigative abilities. Auditors must work independently, be objective in their assessments, and possess skills to communicate effectively. 

For more complex processes, the What If study is best organized through the use of customized checklists. Aspects of the process a re assigned to analysis team members with the greatest experience or skill in areas of concern. As a What-lf study could include but not be limited to audits of equipment operator practices and job knowledge, the suitability of equipment and materials of construction, the chemistry of the process and its control systems, and the operating and preventive maintenance records (Task Analysis Tools Used Throughout Development, Human Error Analysis, n.d.). 

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