When to Audit

The supervisor or project inspector must perform daily inspections of active worksites to detect hazardous conditions resulting from equipment or materials or unsafe work practices. The supervisor, inspector, or site safety and health officer must 

Supervisors and employees should check the equipment and materials that they will use during the operation or work shift for damage or defects that could present a safety hazard. 

Employees should immediately report identified hazards to their supervisors. 

The supervisor or project inspector must perform daily inspections of active worksites to detect hazardous conditions resulting from equipment or materials or unsafe work practices. The supervisor, inspector, or site safety and health officer must perform periodic inspections of the workplace at a frequency established in the worksite s specific safety and health program. The supervisor, in conjunction with the site safety and health officer, should determine the required frequency of these inspections based on the level and complexity of anticipated work activities and on the hazards associated with these activities. In addition to a review of worksite conditions and activities, these inspections must include an evaluation of the effectiveness of the worksite safety and health program in addressing site hazards and in protecting site workers. The safety and health officer may need to revise the safety and health program as necessary to ensure the program s continued effectiveness. Work crew supervisors, foremen, and employees need to inspect their workplace before the start of each work shift or new activity. At a minimum, supervisors and employees should 

Check the work area for new or changing site conditions or activities that could present a safety 

Report identified hazards immediately to their supervisors 

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However, the qualitative differences between U.S. inspections and Norwegian audits are so great that a comparison of the number of inspections does not in itself tell us much. Therefore, the best way to describe these differences is to show concretely how PSA decides where and when to audit and inspect and how these audits and inspections are carried out. 

It should be noted that the data collection and conversion effort is not trivial, it is company and plant-specific and requires substantial effort and coordination between intracompany groups. No statistical treatment can make up for inaccurate or incomplete raw data. The keys to valid, high-quality data are thoroughness and quality of personnel training comprehensive procedures for data collection, reduction, handling and protection (from raw records to final failure rates) and the ability to audit and trace the origins of finished data. Finally, the system must be structured and the data must be coded so that they can be located within a well-designed failure rate taxonomy. When done properly, valuable and uniquely applicable failure rate data and equipment reliability information can be obtained. 

With electronic notebook studies, there will also be paper data to audit. This will include facility data (e.g., weather data, equipment maintenance records, storage temperature logs, personnel records, etc.) and study specific documents, such as faxes, e-mails, paper notes, etc. When paper data have been transcribed into the electronic notebook, they should be checked by QA to ensure accuracy. Any data that have been transcribed for whatever reason must be identified as such with the original raw data attached to them. QA should ensure that all paper data have adequate identification (e.g., study and trial numbers), that they are recorded per GLP, including dated signatures, and that all of the pertinent paper data or exact copies are sent to the Study Director for archiving. 

For laboratories seeking external accreditation of their work, audits must be planned and written down so that the laboratory can show that they are being carried out. You should note that a laboratory will not be criticized for finding problems when they audit their work. The important thing is to be on the lookout for problems, to find them where they exist and to put them right. No laboratory should rely solely on periodic assessments by an external body to ensure that standards of quality are continuously maintained. There are a number of reasons for this. 

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

Scope of accreditation comes to refer to a detailed list of individual tests in conformity with accreditation references and reflects the situation of a given laboratory at the time when an audit is conducted. Each test is specific to a product or type of products analyzed, to a set of parameters measured, to a range of measurement applicable to this particular test, and to test methods used by a given laboratory for this particular test. Product as a concept could also be expressed as a range of product. Accreditation for a test method could drown methods considered as equivalent if they are established via identical methodology-... 

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. 

Classifying infrastructure software is useful when planning compliance activities. The objective is to make compliance both meaningful and cost-effective. There are two questions that need to be answered (1) "Do we need to audit the supplier " and (2) "Is white box testing required "... 

When we audit an entity, we perform an examination of it. Dictionaries typically emphasize official examinations of (financial) accounts, reflecting the accounting origin of the term. Accounting texts go further for example, testing and checking the records of an enterprise to be certain that acceptable policies and practices have been consistently followed (Carson and Carlson 1977, p. 2). In the human factors field, the term is broadened to include nonfinancial entities, but it remains faithful to the concepts of checking, acceptable policies/practices, and consistency. 

How often to audit Auditing should be on a periodic schedule. A good procedure is to set an expiration date on each standard at the time it is set MIL-STD-1567 says annually. A rule of thumb is to have it expire at 24 months if the application is <50 hr/year, at 12 months if between 50 and 600 hr/year, and at 6 months if over 600 hr/year. Then, when the standard expires, and if it is still an active job, an audit is made. If it is not active, the standard wUl be converted from permanent to temporary. Then, if the job is resumed, the temporary can be used for a short period (e.g., 30 days) imtil a new permanent standard is set. An advantage of a known expiration date is that if a standard is audited (and perhaps tightened), the operator wiU not feel picked on. 

Safety audit unit should be based on the project s objectives and its safety audit risk level selected auditors, determination of audit project leader. In determining the audit staff should strictly implement the avoidance system, and maintain the independence of the audit team members. In considering the staff, attention should be paid to the professional knowledge structure and competence, hire safety professionals when necessary. Audit project manager carry on the division of the members according to the specific target of auditing projects. 

When a contract company employs a subcontractor, the contract company is usually responsible to the client for the subcontractor s work. The client will also generally have the right to audit the subcontractor s performance. 

Safety audits must meet this definition to be effective A safety audit is a stractured approach to provide a detailed evaluation of safety effectiveness, a diagnosis of safety problems, a description of where and when to expect trouble, and guidelines concerning what should be done about the problems. 

Several chapters in this book speak of the significance of design and engineering within the practice of safety, and they can serve as references for safety professionals who want to be more proficient in assessing design and engineering practices when making audits. 

There are a variety of numerical scoring systems for the elements reviewed when safety audits are made. The scorings are subjective assessments that are eventually translated into a finite score. My experience has been that the final score often did not relate to the accident experience that eventually evolved. Nevertheless, safety audits, properly conducted, provide highly effective, qualitative performance measures. 

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