Addressing Audit Results

The assessor should verify that there is a comprehensive formal system that specifies self-audits on a planned frequency. Over time, all areas should be audited. Results should be reported to maiiagemeiit with appropriate follow-up documented. Self-audits should be thorough, addressing all aspects of the area s fuiictioiis. Outsiders riot working in the specific audit area should be iiicluded ill the exercise for objectivity. 

Your corrective action procedures need to cover the collection and analysis of product nonconformity reports and the collection and analysis of process data to reveal process nonconformities. The corrective action provisions of your internal audit procedure need to address the causes of the nonconformities and you will need an additional procedure to deal with external audits, investigating the cause of any nonconformities and recording the results. The procedure also needs to cover the investigation of customer complaints as the previous requirement only deals with the handling of complaints. 

Identifying and analyzing fire hazards and scenarios is the next step in a fire risk assessment. The hazard identification should be structured, systematic, audit-able, and address all fire hazards, including nonprocess fires. The result of the hazard identification is a list of potential fire hazards that may occur at the facility, for example, jet, pool, flash, BLEVE, electrical, or Class A fires. This list should also include the location where each fire could occur. Hazard identification techniques used to identify potential hazards are shown in Table 6-1. 

The frequency of the validation review should be addressed in the final validation report and may be determined against elapsed time or the number of batches processed, anomalies in results of in-process and end-product testing, and questions arising from internal or external audits. 

Internal QA audits must be conducted and documented at a defined frequency to ensure overall compliance, control, and effectiveness of the quality elements. Such audits should be conducted by members of the QAU or third-party compliance specialists and the results reported directly to the senior management of the corporation. The senior management should prepare an action plan to address any deficiencies and follow up to confirm adequate implementation. 

Standard procedures for conducting the quality audit should also be addressed in the Vendor qualification program. An audit cycle includes the preparation of an audit, performance of the audit, reporting of the results of the audit, and audit closure or follow-up requirements. Figure 2 illustrates the audit process. 

As a result of the audit, the vendor is responsible for developing a corrective action plan to address any weaknesses or deficiencies identified by the sponsor s auditors. It is the sponsor s responsibility to ensure that the corrective... 

Upon completion of the audit, the auditors should provide the contractor with a report citing any problems which they have identified with the contractor s operation that might interfere with the contractor being able to successfully work on their company s project. The contractor should respond in writing to the audit report and address how they will handle each observation. Based on the results of their audit and the responses of the contractor, the audit team can then make a recommendation to the responsible personnel within their organization as to the acceptability of the contractor. 

The Pharmacy and Therapeutics Committee should establish or assign a committee or department to monitor the effectiveness of the interchange policies. Audits or reviews should be conducted according to set policies. Criteria should be developed and used to determine when and why the therapeutic interchange policies may be ineffective (see Guideline II). The issues identified should be addressed and the professional staff notified of resulting changes to policies and procedures. 

Every item in the report that requires a response must be addressed. Information must be provided for action items to describe the outcome of the action taken. All responses should be filed with the audit plan, together with resulting documents such as certificates of accreditation or notification that all outstanding items have been resolved. 

Lack of Self-Criticism—The audit or oversight of the organization is limited, with a lack of an unbiased outside views. The oversight system is not formal and any results are not part of the leadership team s internal review. These observations can detect disconnects between operational conditions and the existing self-assessment. Problems remain unidentified, unreported, or not addressed. Adapted from US Department of Energy, Human Performance Handbook (Volume 1 Concepts and principles, human performance improvement handbook, 2009)... 

After this work is complete, the results of the audit activity will be analyzed, and reported with specific findings and recommendations for corrective action based on the findings. Typically a draft report is prepared and submitted to facility management and in-house counsel for review and comment. A final audit report will then be prepared, followed by development of corrective action plans to address noncompliance issues identified in the audit report. 

Placing too much emphasis on injury-producing events but not focusing on potentially serious close call incidents can result in unreliable effective assessments. Rather than relying solely on injury rates or other postevent assessments, organizations could use a broader hazard control audit process. This management style audit would address several key components of the accident prevention process. The audit forms would help evaluators rate each component against prepublished... 

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