What to Audit

The complexity of the worksite and the myriad areas, equipment, tasks, materials, and requirements can make the content of most audits overwhelming. As seen in Rgure 7.3, the audit topics that could be targeted on a worksite are expansive. 

Safety and health audits should be an integral part of your safety and health effort. Anyone conducting a safety and health audit must know the workplace, the procedures or processes that are audited, the previous accident history, and the company s policies and operations. This person should also be trained in hazard recognition and interventions for safety and health. 

Electrical equipment Lockout/tagout Walls and floor openings 

Safety and health audits/inspections can be done on or for the entire plant (e.g., manufacturing), a department (e.g., quality control), a specific worker unit (e.g., boiler repair), a job or task (e.g., diving), a certain work environment (e.g., confined spaces), a specific piece of equipment (e.g., forklift), a worker performing a task (e.g., power press operator), or prevention of an event (e.g., fire). It is important to ensure that inspections and audits be tailored to meet the needs of your company regarding auditing for safety and health concerns. 

Gas Cylinders Gas Engines Gases Generators Hand Tools Hard Hats 

Walls and Floor Openings Warning Devices Welding and Cutting Work Permit Working Surfaces Unsafe Conditions Unsafe Acts X-Rays 

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What to audit To keep the work-measurement system up to date, accurate, and useful, MIL-STD-1567A says the audit should determine (1) the validity of the prescribed coverage, (2) the percentage of type I and II coverage, (3) use of labor standards, (4) accuracy of reporting, (5) attainment of goals, and (6) results of corrective actions regarding variance analysis. 

These lists tell us something about the nature of quality records, especially by what is not included. Absent from the lists are policies, procedures, instructions, plans, specifications, and any other prescriptive documents. The records all have one thing in common they describe the results of some activity - the results of inspections, tests, reviews, audits, assessments, calculations, etc. However, these lists are dominated by records relating to product quality rather than to the operations of the quality system. In addition to audit records, the following records may need to be maintained to demonstrate the effectiveness of the quality system ... 

Hazard assessment findings are similar to audits, in that they are periodic measures. Hazard assessments might include Hazard and Operability (HA-ZOP) studies, What-If/Checklists, Fault Tree Analyses, or other techniques. The results of these studies will indicate what types of hazards exist and whether or not these hazards are sufficiently controlled. 

QA SQPs should specify the amount of data to be audited and how the data points are chosen for audit. An auditor may choose to perform more thorough and more frequent audits on a recently validated system. The validation report can be used to assist in determining what and how much to audit. For example, if data summary printouts from the chromatographic computer system are used in the report, the validation report should be reviewed to verify that this summary function was tested during validation. If this portion of the computer software was successfully validated, verifying a few values from each table in the report may be sufficient. 

What are two entities that are permitted to audit a laboratory facility What are some of the things that auditors look for ... 

Motise, Paul J. Pharmaceutical Manufacturing July, 1984, "What to Expect When FDA Audits Computer Controlled Processes". 

The laboratory to be inspected will receive a letter approximately two weeks before the Agency inspection team arrives that specifies which studies will be audited and if a laboratory GLP inspection is to be included. Upon arrival, the inspector will present official credentials and a Notice of Inspection form. The GLP portion of the audit is now conducted as if GLPs for all types of studies were in effect. For those laboratories conducting non-GLP studies, this is done to give an idea of what to expect when, and if, the GLP regulations become law. The laboratory inspection aspects will be reviewed briefly and then the data audit portion will be discussed. 

Provides an effective matrix to audit against while conducting internal or third-party audits. Can historically assess what worked or did not work over time. 

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. 

What standards or guidelines are being used to audit against ... 

One aspect that may have become rather obvious from the above paragraphs is the fact that the same words may not mean the same things in different quality systems. What quality means for GLP in contrast to what it signifies to accreditation has been described above. What an audit is for accreditation is an inspection for GLP, and the GLP audit would be termed a review by the accreditation expert. Therefore a dictionary might be needed to bring the various quality systems to common terms. This problem has been already the subject of a number of papers (e.g. Dybkaer, 1994 Plettenberg, 1994) and discussions, and we need not develop it further here. 

If you toured a lab facility, you probably toured a wet lab, a quality control lab, or perhaps a process development lab, or maybe all of the above and wondered what these terms meant. You probably saw a control chart and wondered what it was. You may have sat in on a meeting to prepare for the upcoming quality assurance audit and wondered what an audit actually was or what GLP, MSDS, and SOP meant. You may have heard someone talk about certified reference materials and wondered what that was. You may have encountered a formal means of disposing of chemical waste and said, Wow Or you may have noticed an experiment or an instrument that wasn t working properly and, subsequently, observed chemists and technicians teaming together for troubleshooting. 

Principle. Good documentation is an essential part of the quality assurance system and, as such, should be related to all aspects of GMP. Its aims are to define the specifications for all materials and methods of manufacture and control, to ensure that all personnel concerned with manufacture know what to do and when to do it, to ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale, and to provide an audit trail that will permit investigation of the history of any suspected defective batch. The design and use of documents depend upon the manufacturer. In some cases some or all of the documents described below may be brought together, but they will usually be separate. 

Demonstrable evidence in support of responses to audit questions should be sought whenever possible. Supplier responses should be challenged by asking how, where, when, what, why and who. 

The EPA uses these letters to determine what plants to audit for compliance with the polymer exemption, and to track how often companies rely on the polymer exemption. 

It is important to prepare a list of who receives the draft and final reports. A wide circulation will allow many people to understand what the audit found and to take corrective actions in their particular areas. But an audit report can create legal liability problems so the distribution list should also be screened by the company s legal department. Also, it needs to be recognized that the report could be embarrassing for some of the managers, so their concerns should be recognized. 

Figure 9.1 shows the SMS sections, the elements, the minimum standards, and the minimum standards detail, as well as the point allocation for those particular standards. To ensure conformity of measurement, an audit book incorporates an auditor s guide indicating what to look for during the physical inspection, documentation to verify the measurement, and questions to ask to ascertain conformance to the standard. Figure 9.2 is an overview of a structured SMS. 

Audit instruments can be evaluated on the basis of three different types of validity when linking the audit to safety performance. These are content-related, criterion-related, and construct-related procedures for accumulating evidence of validity (Anastasi 1988, 139). Content-related validity involves the examination of the audit content to determine whether it covers a representative sample of the behaviors to be measured. Criterion-related validity procedures indicate the effectiveness of an audit in predicting performance in specified activities. The performance on the audit is checked against a criterion that is considered a direct and independent measure of what the audit was intended to measure. The third type of validity, construct validity, is the extent to which the audit is said to be measuring a theoretical construct or trait. Construct validation requires accumulation of information from a variety of sources. 

First, determine what needs to be audited. You might want to audit specific occupations (e.g., machinist), tasks (e.g., welding), topic (e.g., electrical), team (e.g., rescue), operator (e.g., crane operator), part of the worksite (e.g., loading/unloading), compliance with an OSHA regulation (e.g.. Hazard Communication Standard), or the complete worksite. You may want to perform an audit if any of the previous items or activities have unique identifiable hazards, new tasks involved, increased risk potential, changes in job procedures, areas with unique operations, or areas where comparisons can be made regarding safety and health factors. 

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