Skills audit

The systematic approach to analysing the competency of the R D Group is the Skills Audit, which involves the following three steps. 

The level of team members effectiveness depends on skills, experience, and the guidance they follow. A formal audit protocol provides the user with step-by-step instructions on how to conduct the audit, and thus can be used by less experienced auditors. Use of less formal assessment guides such as topical outlines requires more experienced auditors. Either way, the skill level of an audit team must be sufficient to enable members to ... 

The most fundamental skill required is interviewing, an area in which many technically proficient managers may lack experience. Other important skills and techniques include writing findings, sampling and taking notes during the audit. 

A QA system describes the overall measures that a laboratory uses to ensure the quality of its operation. Typical items include suitable equipment, trained and skilled staff, documented and validated methods, calibration requirements, standards and RMs, traceability, internal QC, PT, nonconformance management, internal audits, and statistical analysis. 

Auditor skills and expertise in the area being audited are inadequate. 

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. 

Audit skills—A CQA professional should be quite skilled in the area of auditing and capable of evaluating everything from documentation within the CRO, sponsor, and investigator sites. 

Auditing the current skills of the staff in the R D Group, the Skills Base. 

Individual procedures can easily consume 10 to 15 days effort to produce, even with experienced staff. Use should be made of industry guidance when developing procedures, e.g., GAMP example procedures and IEEE standards. Where existing procedures are being revised to secure validation compliance, this estimate of effort could be reduced by about half. As recommended above, this should be supplemented with about 20 days effort across all the procedures, shared among a team of end users. The individuals should contain the core users who are involved in all the procedures in order to ensure consistency. Other end users on the team, however, can be seconded for the development of particular procedures in which they have a specific interest, or can contribute a particular skill or competence. For instance, an end user quality representative may wish to be seconded for the development of the Supplier Audit procedure. 

It is useful if the supplier has nominated a representative to host the audit, ideally someone who has been trained in auditing and therefore can understand and anticipate the auditor s perspective. Training courses are available, for instance, along the lines of industry auditing standards like ISO 10011. Good interpersonal and language skills are often beneficial, too, especially where the audit is not conducted in the participants mother tongue. 

The person performing an IT vendor audit needs to know the standards used, understand how an IT developer organization works, and what to expect of them. Being a GMP auditor does not make a person competent to perform IT vendor audits. It might be wise to obtain help from an external consultant if your company does not have the skills internally. 

---