Facilities audits

Facility Audit The facility audit includes all aspects of the facility that are listed in the GLP regulations. These include the personnel (Subpart B) as well as the laboratory itself (Subpart C), the equipment used in the laboratory (Subpart D), the test substances, reagents, and samples used (Subpart F), and the laboratory information systems. 

Also included in a facility audit are the computer programs and systems used to generate data. Most important is whether or not these have been validated and tested for system suitability. 

Figure 8.1 During a facility audit, the QAU examines all personnel files to see if educational requirements are met. 

According to information from 3M as well as from numerous facility audits, the initiation of an effective waste reduction program begins with a strong management commitment. It is advisable to "work from the top down". The plan can be implemented beginning with a waste minimization assessment such as the one detailed in the EPA assessment manual (USEPA 1988). 

A comprehensive document describing the applicable validation requirements for a given facility, and providing a plan for meeting those requirements. The VMP provides a road map for validation, to establish a sequence of events followed by facilities audits and inspections. 

Preagreement facility audit or due diligence to determine if the lab is fit for purpose. This is usually carried out by the sending lab s QA unit, although sometimes they may be accompanied by the relevant lab scientist. 

Project-specific inspection carried out when there is an ongoing relationship. The facility audit has usually been carried out previously, so the objective of this is to ensure the current project is within the capabilities of the operation. 

Project-specific inspections are usually carried out by the relevant scientists from the sending lab and are usually a follow-up to the general facilities audit that precedes the implementation of a specific project. A growing, but not yet dominant, trend is for the sending lab representative to interview the scientists at the receiving lab in informal discussion. The objective is to identify a compatible study director as well as analysts on apersonal basis. In addition, it is essential to identify the study director s competencies with respect to the specific project in terms of their CV and training records. 

In order to verify the compliance for those parts of systems that are controlled by the central computer services group, facility audits have to be performed of these facilities at regular intervals. 

The Audit Policy encourages companies to enter into multi-facility corporate auditing agreements to avoid some of the problems that can arise when audits are performed serially at several facilities. For example, a company that is conducting a multi-facility audit could be partially precluded from obtaining Audit Policy relief if any of its facilities is inspected by EPA prior to... 

The responsibilities of Navy headquarters include establishing and specifying SUBSAFE requirements, verifying comphance with the requirements, and providing SUBSAFE certification for each submarine. Compliance is verified through two types of audits (1) ship-specific and (2) functional or facility audits. 

Functional or facility audits (such as contractors or shipyards) include reviews of policies, procedures, and practices to confirm compliance with the SUBSAFE program requirements, the health of processes, and the capability of producing certifiable hardware or design products. 

Other factors that need to be taken into consideration are cell manufacturing facility audits, destructive analysis of fresh cells and stringent screening techniques to identify cells that have the potential for internal shorts that are not detected by any of the cell acceptance tests carried out at the manufacturing facility or during initial screening of the cells in the battery buildup process. More details for this screening process are provided in Section 5. 

Internal typically means the facility audits itself with no outside influence. This is termed a first-party audit,... 

It is the auditor s job to assess the effectiveness of the environmental compliance and the management control that is in place at the semiconductor facility. Auditing will be principally conducted through the review of documents, files, test data, and interview of key personnel, and by visual observations. The data relating to on-site environmental controls will be compared with information from environmentally compliant/acceptable systems. 

To assist you in the development of an environmental compliance audit program, a sample environmental compliance and environmental management audit checklist is included in Appendix B of this chapter. The checklist has been developed to cover the eleven subject compliance areas discussed earlier. To maximize the use of the model checklist, each semiconductor facility audit team should tailor it to reflect the scope of their manufacturing activities, specific site conditions, chemical usage patterns, and inclusion of applicable state, regional and local regulatory requirements. 

Conduct regular facility audits to identify and address conditions. 

Audit forms typically carry with them a score. This score provides a numerical comparison of the results of one facility to the other. You can imagine that with the competitive nature of human beings, the score received on audits will be hotly contested. When considering even the general audit form offered in Appendix E, an answer to every question may not be forthcoming from every facility audited however, when the audit is being performed, a certain part of the facility may be shut down or certain information may be unavailable or not applicable. So, it may turn out that not all questions will be answered. In any case, the auditor needs to stay flexible when performing an audit. 

Audits and surveys performed by outside professionals fire inspections, facility audits, and workers compensation data are all a part of the document survey. 

Facilities Reviews There are many lands of facilities reviews that are useful in detec ting and preventing process safety problems. They include pre-start-up reviews (before the plant operates), new-plant reviews (the plant has started, but is stiU new), reviews of existing plants (safety, technology, and operations audits and reviews), management reviews, critical instrument reviews, and hazardous materials transportation reviews. 

Postaudit Process The postaudit process consists of preparation of a draft report, preparation of a final report, development of artion plans, and follow-up. A draft report of the audit findings should be prepared shortly after the completion of the on-site audit. The draft report usually undergoes review and comment by facility personnel involved with the audit, experienced auditors not involved with the subject audit, functional specialists, and attorneys. The review of the draft report is done to assure that a clear, concise, and accurate report is issued, and not to modify or change the findings. Once this review procedure is completed, a final report can be issued and distributed based on a distribution list provided by the facility personnel. The final audit report should be issued in a timely manner and meet the time requirement specified in the audit plan. 

An action plan shoiild be developed by the appropriate personnel of the audited facility to address any deficiencies stated in the audit report. Action plans should state what is to be done, who is responsible for getting it done, and when it is to be completed. Ration e for not taking any action for any of the stated deficiencies should also be documented. The action plan is an important step in closing the audit process. 

It would not be unusual for some action plans to take a long time to complete. When extended implementation time is necessary, a follow-up mechanism should be used to document progress and show that an effort is being made to resolve the issues. Periodic (i.e., quarterly, semiannually) progress reports should be used as a follow-up method to ensure implementation. Future audits of the facility should include confirmation of the implementation of previous audit action plans. 

The final audit report, action plans, progress reports, and any closure report should be retained by the facility based on the facihty record retention pohcy. Typically, these items will be retained until future audit documentation replaces them. In some cases, audit records are retained for the life of the plant. 

The client will want to ensure that it has access to and the right to audit the tolling facility. Factors that may be negotiated and formalized in the contract include ... 

The contract can specify the amount of time the client needs to remove its materials from the toller s facility and lays out notification procedures for dissolving the contract. Chapter 6, Closure and Audit, Example 6-1 is a sample contract termination checklist. It is an illustration of one company s inventoiy list for closing out a tolling project. It addresses material, financial, legal and environmental considerations. 

Does the facility evaluate (for example, audit) the off-site waste management facilities used to manage hazardous wastes If yes, do the evaluations ensure that wastes will be handled safely, without causing harm to waste handlers, the public, or the environment Flave the reviews been documented ... 

The objectives of the audit are first to develop a baseline of the environmental performance of the facility, and then to assess one or more corrective actions (P2 activities) with attractive economics which improve environmental performance. 

Step 1.3 Identify and Allocate Additional Resources. The audit may require external resources, such as laboratory facilities and possibly equipment for air sampling, flow measurements, energy measurements, and product-quality testing. 

Step 1.4 Select the Subject Facility. It is important to decide on the focus of your audit during the preparation stage. You may wish to audit a complete process or you may want to concentrate on a selection of unit operations within a unit process. 

---