Audits reliability

Rothwell PM, Warlow CP (1995). Is self-audit reliable Lancet 346 1623... 

The third technique to guarantee audit reliability is to ensure that the audit is conducted by competent people. Although competency is a difficult characteristic to define, auditors must have several characteristics before they qualify ... 

PrH A improves the safety, reliability and quality of the design and construction of a new or old process. P IDs must be correct as constructed operating, startup and shutdown procedures must be validated, and the operating staff must be trained before startup. Incident inr estigation recommendations, compliance audits or PrHA recommendations need resolution before startup. 

The last category of techniques are various forms of checklists of factors that can influence human reliability. These are used mainly in a proactive auditing mode. They have the advantage that they are quick and easy to apply. However, considerable training may be necessary to interpret the results and to generate appropriate remedial strategies in the event that problems are identified. 

It should be noted that the data collection and conversion effort is not trivial, it is company and plant-specific and requires substantial effort and coordination between intracompany groups. No statistical treatment can make up for inaccurate or incomplete raw data. The keys to valid, high-quality data are thoroughness and quality of personnel training comprehensive procedures for data collection, reduction, handling and protection (from raw records to final failure rates) and the ability to audit and trace the origins of finished data. Finally, the system must be structured and the data must be coded so that they can be located within a well-designed failure rate taxonomy. When done properly, valuable and uniquely applicable failure rate data and equipment reliability information can be obtained. 

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... 

Core attribute Fundamental underlying property of a protection layer. The core attributes are independence, functionality, integrity, reliability auditability management of change, and access security. 

Hale A.R., Guldenmund F., Bellamy L., Wilson C., 1999. IRMA Integrated Risk Management Audit for major hazard sites, in Schueller et al. (Eds.), Safety Reliability, Balkema, Rotterdam, pp. 1315-1320. 

It is necessary to ensure suppliers of materials have in place appropriate quality systems and that they are reliable. External audits may be required to inspect and confirm the supplier s facility and quality system. 

Applications for marketing should be sent to MHLW. The application then passes to PMDA, where the application splits into two different routes, namely (1) good laboratory practice (GLP), GCP and reliability compliance check by Office of Conformity Audit and (2) application review by Offices of New Drug or Office of Biologies. 

First, the Office of Conformity Audit will conduct a compliance review to ensure that the dossier meets the standards of GCP, GLP and reliability. The GCP compliance check is based on the inspection of both study sites and sponsor. For the submission of new active substance usually four study sites are inspected. If the pivotal studies are conducted overseas, the inspection may be conducted by MHLW instead of PMDA. 

System Evaluation and Supplier Assessment Usually there are many choices and suppliers for common COTS laboratory instruments. The user requirements and the operational requirements will provide the basic criteria for the selection. Obviously the chosen instrument must be able to fulfill the key requirements for its intended use. Other factors concerning the instrument such as its ease of use, maintenance, and reputation of the suppliers in terms of quality, reliability, and support should be considered. From a practical point of view, a supplier audit may not be viable or necessary for commonly used COTS instruments. A supplier assessment is sometimes used to evaluate whether the supplier has a good-quality system in place to support the development and manufacturing of the instrument of interest. The need for a supplier assessment depends on the criticality and complexity of the system to be obtained. 

Vendor s reliability. The vendor that supplies the instrument should have a track record of providing high-quality instruments and after-sale support. A vendor audit should be conducted for a new instrument supplier to evaluate the company s ability to build high-quality products. Purchasing an instrument from a financially unstable vendor is risky. 

To quickly locate any given document, it is mandatory to have implemented an appropriate documentation system. In case of a fault in production or inspection, it becomes necessary to find a document within 15 to 20 min. All companies should test the reliability of their documentation system using internal audits. 

Unauthorized manipulation of records, audit trail records, and replay of transmissions must be reliably identified as errors. The recipient can use three approaches to authenticate data/messages. 

Financial Quality audit upon receipt Reliability of vendor... 

The general approach to retrospective validation is the same as for prospective validation (see Chapter 6 to Chapter 11). However, it may not be possible to condnct some prospective activities such as Supplier Audits if the supplier is no longer trading. Source Code Reviews if there is no access to source code and relevant design documentation, and Development Testing if detailed design information is not available. Historical records demonstrating reliable operation may be available to aid validation. 

Common problems both on the operational and support aspects of the computer system should be part of any validation plan, e.g., backup works and incorrect data inputs can be corrected in a compliant way with corresponding audit trail entries. The predictability of the system under these tests must generate confidence in the CDS operations (trustworthiness and reliability of electronic records and electronic signatures) and the IT support. 

Advertising successes of the process safety improvement effort demonstrates that improvement is possible. Well-crafted stories also explain the benefits that accrue to everyone in the organization. Of particular interest are stories where a process safety weakness was observed, possibly during a process safety audit, and an improvement effort corrected the identified weakness before it could manifest into an accident. Metrics can validate such improvements. Another example is improved reliability from timely maintenance of safety devices as demonstrated by metrics that educate personnel not only about the hazards, but also about the importance of reliable safety systems in managing those hazards. 

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