Audits follow

A code user may rely on the results of an independent audit of code as long as that audit followed appropriate steps as outlined. 

One of the attractive and also risky features of the implementation of a LIMS is that it can be done rapidly. This will, therefore, reduce the amount of time available for ensuring that the appropriate "quality" is built into the system, which is especially the case when implementing a replacement LIMS. The simple answer is that the pharmaceutical manufacturer must ensure that a "quality supplier" is being used for the LIMS. This is easy to state but difficult to do there are many suppliers on the market who will advise that their systems are the best and that they are also The pharmaceutical manufacturer must take appropriate steps such as performing a Supplier Audit, following up references and so on before any decision is made. 

The new I C systems have been assigned classifications in accordance with lEC standard No. 61226. The selection of standards to be used as the basis for the audits follows this classification and addresses all of the important issues at a level of detail that is suitable for conducting the audits and for addressing the applicable SUJB requirements. Hence ... 

An audit is of no value if the facility management does not follow up on its findings. Ideally, senior management will review the audit, the audit process and the audit follow-up very carefiiUy—aU the time asking what improvements can be made to the management systems. 

Companies are becoming more and more involved with customers and suppliers. Both raw materials and products are tracked from inception. Documentation, quality charts, and external audits follow products and raw materials from cradle to grave. Customers are providing more information about their needs to companies. 

Post audit follow-up and development of corrective actions plans... 

Announced and Unannounced Safety Audits 180 Reporting and Posting Audit Results 181 Audit Follow-Up 181 Conclusion 181... 

SHE audits are the main tools of Norskoil s SHE manager for follow-up on safety in construction. The contractor s site safety co-ordinator also performs audits of this type. The audit team checks actual performance against regulatory and contractual requirements and the yards SHE programmes. The audits usually consist of two parts, i.e. a system part and a technical part. In the system audit, the SHE manager checks SHE documentation and practices in relation to the commitments in the SHE programme. The technical audit is carried out as workplace inspection. The audits follow a schedule and each audit covers a separate theme. Below are examples of audit themes ... 

Follow-Up. If no savings result, the effort has been wasted. Thus the audit leader must ensure that the potential of every good design idea is recognized by management and the project-generation channels of the company. 

Quality Audit. Another important responsibiUty of quahty assurance is the audit function. Using the quahty audit as a tool, QA can monitor the operation of the manufacturing faciUty a toU, ie, contract, manufacturer or raw material suppHer to assure that written procedures are in place and that there is documentation to indicate the procedures are being followed. Properly executed audits allow QA to spot potential weakness in the quahty system that could allow errors to occur. Once identified, these weaknesses can then be corrected before they result in nonconformance. 

Process Safety Analysis This part treats the analysis of a process or project from the standpoint of hazards, risks, procedures for making potential damage estimates, and project reviews and audits. It can be helpful to management in assessing risks in a project. It consists of the following ... 

Follow up at regular intervals (for example, during audits) to see that the recommendations made after accidents are being followed, in design as well as operations. 

To distinguish between a review and an audit, some definitions will be provided. A review is a critical examination or evaluation of any operation, procedure, condition, event, or equipment item. Reviews can take many forms and be identified as project reviews, design reviews, safety reviews, pre-start-up reviews, and so on. The following discussion of the review process will deal with project reviews associated with capital projects and focus on the area of process safety. 

The following sections will describe the project review and audit processes separately, addressing the why, when, and how for each process. 

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. 

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. 

Chapter Five—Ongoing Operations Audits and Follow-up... 

The following sections provide guidance and some examples for addressing these ongoing activities. The flowchart on the next page shows a typical sequence of ongoing operations and audits. 

Figure 5-1. Ongoing operations audits and follow-up flowchart...

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