Individual Audit

PSM or RMP audits have multiple objectives. Most important is the assurance an audit brings or the adequacy of implementation of the particular program. Specifically, the audit measures program effectiveness, identifies deficiencies, and verifies correction of previously identified deficiencies. The audit also provides management with a status assessment and may recommend improvements and identify good practices. The material in this section is based on a portion of the content of a Nuclear QA Certification Course taught at Sandia National Laboratories and several companies, the ASQ Nuclear Auditor Training Manual (ASQ 1986), the System Safety Analysis Handbook (Stephans and Talso 1997), and the OSHA Inspection Manual (U.S. Department of Labor 1994). 

Administrative Preparations Debriefings of interviewees Auditor interactions 

Pian/Scheduie Briefing - Scope/Ground rules 

Correct known fauits Receive /assess report Perform Corrective Action Respond back to report Prepare Lessons 

When the report is drafted, written preparation of the individual findings is important. If only the OSHA PSM Checklist is used, the task is easier, but application to the EPA RMP and in the nuclear area it may be more difficult. 

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For each individual audit, it is useful to prepare an audit plan to provide the auditee with an overview on the audit components and the conduct of the audit. An audit plan may also be useful as a basis for agreement between the sponsor, the (external) QA auditor and the audit team. It is common practice in clinical research to draw up an audit plan and distribute this information prior to the audit. 

Topics addressed in this chapter include audit purpose, QA interface, internal and external audits, conduct of audits, lessons learned, and information about the Chemical Safety and Hazard Investigation Board. Conduct of audits will include a section on the mechanics of an individual audit that should be most helpful during the periodic review process. 

As an overview, the mechanics of an individual audit are shown in Figure 24-1. The figure depicts the general sequence and procedures used for the formal external audit by an independent review team, but it can also apply to... 

This study first outlined how the OSV and dry bulk segments are subject to a series of mandatory and industry-driven external audits. What effects these audits have will depend largely on the characteristics of the individual audits and the maritime segments. However, we find that, in both cases, compliance is driven by the costs of sanctions, legal and commercial, related to the different audits. 

A quality audit could consist of a number of individual audits, including some or all of the following ... 

It is essential to develop contacts within both companies to create an atmosphere of two-way communication. The toller should feel comfortable in asking for advice or assistance and this is best achieved by building rapport with their primary contacts from their client company. After an audit, the points of contact can be assigned responsibility for ensuring completion of individual action items. 

Step 7 Write an Overall Material Balance. Remember that the P2 audit focuses on a unit process, but that there are individual unit operations that make up this process. The team will need to develop a series of material balances for each unit operation, and an overall material balance about the entire unit process, to bring closure to a solution of parameters of interest. The individual or component material balances developed may be summed to give a balance for the whole process, production area, or factory. 

Develop a list of the individual unit processes at your enterprise. Among these, which are the processes that are most likely to benefit from a P2 audit Why ... 

The Site I subeontraetor also laeked a baekup safety and health supervisor fully trained in site safety and health management. The aeting health and safety speeialist (HSS) at Site E was a site worker who had held the position for one week. This individual stated to the audit team that he did not meet the eorporate or SSAHP qualiheations required to hold that position. Apparently, while the Site E eontraetor was waiting for the results of the LTEV performanee test and the unit was not in operation, site management determined that less health and safety oversight was needed. 

The regular HSS was on a month s leave. Responsibility for management of site safety and health at Site A was assigned to several individuals ineluding the response manager, the Teehnieal Assistanee Team (TAT), health and safety oflfieer (HSO), and the on-seene eoordinator. It was not elear at the time of the audit whieh of these individuals aetually fulfilled the role of full-time HSO, nor was it elear how these individuals would eoordinate and eommunieate on overlapping health and safety issues. 

As with audits, survey results form the basis of a facility-specific report for circulation to facility management and the PSM team. This report may follow the questionnaire format, with responses tabulated and analysis and commentary provided at the end. If necessary, baseline PSM assessments can be performed by a single individual using a survey method. 

Procedures Do Not Correspond to the Way the Job Is Actually Done. Procedures are often developed when a system is first commissioned and are seldom revised to take into account changes in the hardware or the operating regime. In addition, procedures are often not written on the basis of a systematic analysis of the task as perceived by the workers or other personnel who have to use them. The remedy for this is to make sure that individuals who are going to use procedures are actively involved in their development. In addition, effective updating and auditing systems need to be in place to ensure that procedures are correct, and available to the persons who need them. 

Based on the survey we selected individuals at all levels for interviews as part of the audit process... 

Audit findings or scores are useful periodic measures of improvement in PSM and ESH management. Improvement in performance between audits is generally easy to spot. Audits may not be conducted annually at each facility however, if a sufficient sample of facilities is audited each year it can provide a useful indicator of overall change across the company. Of course, the audit results are most relevant to the individual facility managers who can develop action plans for improvement based on the results. 

Demonstrate (refer to earlier demo) that user IDs are unique (cannot be deleted or redundant). If a user ID has been inactivated, can it be reactivated Would these actions be audit trailed If reactivation is not possible, how would a new user ID for a returning employee be linked to the past ID so all records created or signed by an individual could be queried (Does the system provide a technical solution, or would this be handled by a procedure ) Demonstrate controls include such configurable parameters as ... 

Each data point must be transferred from data sheets into spreadsheets or databases. Verification of each datum should be performed by an individual who did not enter the data being verified. Audits of each phase of the study should be performed (i.e. preparation of collection forms, application calibration, each type of sample collection, sample transport, each type of chemical analysis, data recording, data entry, data verification and data storage). 

For FieldNotes, the general log for the test substance will automatically track usage for each application at all sites. When the same container of test substance is used for several studies, the data will appear to be atypical. If QA is auditing individual study data, the numbers will not seem to be accurate for a particular study. QA must be made aware when one container is used for different studies during the audit. Consequently, sending a separate container of test substance for each trial and/or study is recommended in order to facilitate tracking during the audit. 

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