Audits findings

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. 

Have we resolved past audit findings satisfactorily ... 

Step 1.6 Review Documentation. Collate and review all existing documentation and information regarding the process. Regional or plant surveys may have been undertaken, environmental audits may have been conducted, safety audit findings may be available these could yield useful information indicating the areas for concern, and will show gaps where no data are available. 

Employers certify compliance with 29CFR1910,119 every three years. The compliance audit is conducted by one or more persons knowledgeable in the process. A report of the audit findings is prepared. The employer documents the response to each of the findings and their correction. The wn niost reccni compliance audits are retained. 

Based on the audit findings, the team typically issuesa report that summarizes the status of current management systems and identifies pacesetter programs and areas of non-compliance or exceptions. These findings should be provided both to the facility manager and to the PSM team, for consolidation into overall recommendations. A sample audit report is shown in Figure 4-5. 

Compliance. Compare achievement in specific PSM elements against previous audit findings for the site. This helps indicate the effectiveness of the management system. For example, if previous audits found that preventive maintenance was not kept up to date on pressure relief systems, has the system weakness (or absence) that allowed this to occur been corrected ... 

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. 

This element describes systems used to identify and address nonconforming materials or products. For ESH/PSM, this might refer to not meeting relevant standards or specifications for materials and equipment or to audit findings of noncompliance. 

The audit data can now be evaluated, resulting in audit findings (i.e., conclusions both positive and negative). The audit team should confirm that sufficient data has been collected to support each finding. Additional data may need to be gathered if the team decides a preliminary finding needs to be strengthened. The conclusions drawn from the data evaluation should be a team consensus. 

Corrective actions, in a general sense, are the steps taken by a company in response to recognition of a process safety deficiency, either through audit findings or by other means. Some actions may be taken immediately upon notification of a problem, deficiency, or uncontrolled hazard, while other actions may be longer term and require action planning (CCPS1989). 

Quality assurance unit records are exempt from routine FDA inspection and copying authority on the theory that such records are more likely to be complete and candid if they are exempt from review by the FDA. This exemption extends only to records of QA inspection and audit findings and records of corrective actions recommended and taken. All other QA records are subject to inspection and cop5dng by FDA. 

The management reviews are conducted with a planned agenda to provide direction for the company s quality operations. Input from outside and inside sources are welcome to ensure continuous improvement. The audit findings and areas of quality concern are discussed. It is ensured that corrective and preventive measures are taken on time. The review input includes statistical evaluation of process performance and product conformity. 

The quality policies, objectives, and documented procedures are reviewed at specified frequency, and corrective actions are initiated to ensure continual improvement based on audit findings and review of analytical data. 

The follow-up audit is made to close the audit findings. 

Introduce into the selection process the supplier evaluation and audit findings regarding GMP and validation requirements for personnel qualifications, working methods, level of documentation, and in-built system functionality... 

After visiting and inspecting the supplier, the information obtained is analyzed against the acceptance criteria, current company requirements for the validation of computer systems, and the regulatory expectations for computing environments. A report is produced that documents the audit process, provides information on the current state of validation of the supplier and what may be needed for compliance and, based on the audit findings, provides a recommendation on whether the supplier can be used. 

Only experienced quality auditors, such as the chemists who are knowledgeable in the analysis being audited, should conduct external audits. Audit findings give rise to corrective action that is implemented and documented by laboratory operations personnel. However, even the most detailed and frequent audits may be ineffective in disclosing data fraud (Popek, 1998b). External audits are expensive and are usually conducted for government project or major industry client work. 

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