Audit Content

Audits should be modeled for the specific building or operation to which they are applied. Many elements of an effective safety and health program are universal and would apply to almost any location. These basic elements should not be excluded from an audit. 

The following categories and individual elements could be used in an effective warehouse safety audit. 

Most if not all of these items could be included in a formal safety audit. To be effective, the overall safety and health program must be identified item by item and placed in a format that can be easily followed by the individuals conducting the audit. 

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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. 

Nathan had a safety manager state in a conversation that the corporate safety audit content and scoring criteria was increased each year. No matter how hard his plant tried to meet the target criteria, passing the audit became unattainable. He was never able to improve and finally gave up trying. Raising the bar too often leads to disillusionment and lowers the motivation to remain involved. 

Wliat we have included is only a small part of a much longer document available in its entirety at the address shown or on the Web. We provide the complete table of contents so that you get a good idea of the subjects covered and the amount of detail taken to cover them. After the table of contents, we have taken several sections applying to working with hazardous substances. We believe that OSHA has chosen these items to ensure a safe and healthful workplace. COSHOs will use this format when performing an OSHA compliance audit on incinerator sites. 

The audit includes a review of the process safety information, inspection of the physical facilities, and interviews with all levels of plant personnel. Using the procedures and checklist, the team systematically analyzes compliance with the PSM Rule and any other relevant corporate policies. The training program is reviewed for adequacy of content, frequency and effectiveness of training. Interviews determine employee knowledge and awareness ofthe safety procedures, duties, rules, and emergency response assignments. The team identifies deficiencies in the application of safety and health policies, procedures, and work authorization practices to determine live actions. 

The audit report shall provide a full report on the operations audited consistent with the content of Annex 1 of the Rules. The audit report has to contain more detail than an equivalent ISO 10011 audit report (see also Annex 3 requirements). 

Documentation of data origin is essential. Each completed data collection form needs to contain a file reference number or code to connect it to the documentation sources. This provides an essential trail to audit data quality, to confirm risk or reliability estimates or to investigate data values that appear questionable. Procedures to control data during handling, processing, recording, and reviewing are also necessary to prevent loss of data and to assure that opportunities are not lost to check the content of a form, by... 

Must specify the contents of the audit trail and the procedures for printing, reviewing, and archiving the audit log. 

The second edition CD-ROM contains 139 validation SOPs they are made available so that customers can input them into their computers and use their Microsoft Word programs to edit and print these documents. The contents of the procedures are written in simple and precise language to be in compliance with FDA regulation GMP and GLP requirements. The book ensures minimization of the number of documents to avoid the nightmare of the head of quality assurance at the time of FDA audit. The SOPs exclusively refer to the documents specially required for compliance however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. 

We have described a process by which small quantities of foam can be made by the prepolymer method. A number of methods are available to bring the variables involved in prepolymer making under control. We assume that the starting point for such processes is the acquisition of commercial isocyanates, polyols, and additives. Other than for audit purposes, we will assume they arrive with certification that they are of the so-called urethane grade. In the case of polyols, this typically means they contain less than 0.01% water and have good color. Free acids and low metal and chloride contents are important considerations for isocyanates. Manufacturers are well aware of the problems that will arise if these contaminants are not controlled and the materials cannot be used with confidence. 

Acceptance Criteria/Rationale. The acceptance criteria for each measurable attribute (which can be lifted from the specification document) is important and should always be shared. Likewise, it is recommended that a rationale be provided for each criteria. For example, why must the final product moisture content be 70-80% What if it is 83% The reasoning is that it is better to consider this question before being asked by FDA during an audit, thereby avoiding a situation in which the answer provided may not be the best. 

The design of control and monitoring instrumentation and regulating devices should be based on an established document management system that enables preparation to be formally approved, implemented, recorded, and audited. Typical contents and document deliverables of an integrated engineering documentation system are as follows ... 

Authentication, verification, and quality of the contents is a key element for the content acceptance. Include multiple quality control audits and independent peer reviews. 

A table of contents for SOPs and/or test methods—to familiarize the audit team with the procedures available for review and plan in advance which procedures to concentrate on during the audit Previous FD-483s received by the vendor, along with their corrective action plans. A company dress code for visitors—to determine if there are any special dress needs related to safety or the environment being audited... 

The formal audit report is the product of the audit. The lead auditor is responsible for the report content and accuracy and for submitting the formal report in a timely fashion. After completion of the audit, the work on the formal audit report should begin immediately, while audit details are still fresh. In addition, the longer the audit report is put off, the less interested the vendor will be in pursuing corrective actions. It is good practice to complete the final audit report within 2 weeks from the date of the audit. 

Describe the contents of the audit logbook that will be used to confirm the nature and number of internal audits performed. 

Table 5.6 also defines responsibilities. The Originator responsibility is preparing a document or record, Review responsibility is confirming technical content and consistency with other validation activities, and Approve responsibility is authorizing the activity as complete and correctly documented. The Quality Unit may at its discretion, as part of its approval process, review or audit supporting and referenced deliverables. Due account must also be taken where a Supplier Audit determines that the pharmaceutical or healthcare company should take over a lead responsibility for a supplier s documentation responsibilities. The review and approval roles presented in Table 5.6 are consistent with the review of regulatory expectations presented in Chapter 14. 

Appendix 7E Example Contents for Supplier Audit Report.177... 

Suppliers should be advised at the outset of an audit that they wiU be accorded the opportunity to review and correct a draft of the Audit Report before it is issued, as we have mentioned above. There should also be some agreement as to the timetable expected for the issue of a draft report. It is not proper for a supplier to seek to approve the audit report since that could amount to an attempt to gag the auditor. By permitting the audit in the first place, the supplier has effectively given the auditor permission to exercise his/her professional impartiality and this freedom may not subsequently be withdrawn. The contents of the report are the auditor s opinions and should not be influenced except where they are based on factual misconceptions that must be corrected by the supplier. The auditor has a duty of care to the supplier to permit this. The supplier should retain a copy of the draft Audit Report with a note of their review comments. A final copy of the approved and issued report must also be furnished to the supplier by the auditor as the basis for future business relationships. 

EXAMPLE CONTENTS FOR SUPPLIER AUDIT REPORT Introduction... 

Audit trails must be available for the duration of a record s retention period and protected from any form of alteration. It should be possible to establish the current value and all previous values of a record by using the audit trail. Normal working practices (procedural and built-in computer controls) should prevent audit trail content being altered without definitive authorization by a second documented supporting party. Audit trails need to be available with their electroruc records in human readable form for purpose of inspection. 

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