Audits topics

The complexity of the worksite and the myriad of areas, equipment, tasks, materials, and requirements can make the content of most audits overwhelming. As evidenced in Table 15.1, the audit topics that could be targeted on a worksite are expansive. 

TABLE 15.1 Audit Topics Acids Fire extinguishers Personal services and first aid... 

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

The reason for an Exposition is so that there is a description of the system showing how it works and how it controls the achievement of quality. This is different from the policies and procedures. The policies are a guide to action and decision and as such are prescriptive. The procedures are the methods to be used to carry out certain tasks and as such are task related. They need to be relatively simple and concise. A car maintenance manual, for example, tells you how to maintain the car but not how the car works. Some requirements, such as those on traceability and identification, cannot be implemented by specific procedures although you can have specific policies covering such topics. There is no sequence of tasks you can perform to achieve traceability and identification. These requirements tend to be implemented as elements of many procedures which when taken as a whole achieve the traceability and identification requirements. In order that you can demonstrate achievement of such requirements and educate your staff, a description of the system rather than a separate procedure would be an advantage. The Exposition can be structured around the requirements of ISO/TS 16949 and other governing standards. It is a guide or reference document and not auditable. 

The level of team members effectiveness depends on skills, experience, and the guidance they follow. A formal audit protocol provides the user with step-by-step instructions on how to conduct the audit, and thus can be used by less experienced auditors. Use of less formal assessment guides such as topical outlines requires more experienced auditors. Either way, the skill level of an audit team must be sufficient to enable members to ... 

Examples of an audit protocol and a topical outline are provided in Figures 4-3 and 4-4. Whichever audit tool is chosen, it should be used consistently for all audits. 

Regardless of which assessment method you choose, assessors and auditors should take detailed notes using a common format to help capture maximum information in a consistent manner. Forms for questionnaires, topical outlines, and audit protocols (as shown in the exhibits) can perform double duty by providing interviewers with a format for notes as well as reporting. 

This confirmation is often provided by an external audit or assessment (u.s.). Quality management systems are often certified for conformation with ISO 9000. Probably the most common term with respect to our topic here is certified reference materiaT (CRM). 

To reduce barriers to trade the Organisation for Economic Cooperation and Development worked on that topic and pnblished its first decision in 1981. To introduce an internationally accepted system in all countries the OECD pnblished Cuides for Compliance Monitoring Procednies for CLP and Cnidance for the Conduct of Laboratory Inspections and Stndy Audits in 1989 which ate binding for all OECD member states. 

Each organization must devise their own way to conduct an audit. Other readers may wish to consider details of Audits and Corrective Actions or Chapter 13 of Plant Guidelines for Technical Management of Chemical Process Safety [4] which covers broad topics such as Scope, Staffing, Frequency, Reports, and Internal and External Auditors. It is not the intent of this book to cover that aspect of auditing. 

Testing must include, but not necessarily be limited to, the activities listed below nnder the topics of Development Testing and User Qnalification. However, the use of these qualification names is not compulsory. Due account must be taken of any test requirements identified by the Validation Plan, Supplier Audit, and Design Review. Testing mnst not be condncted against an unapproved specification. 

An inventory of systems and knowledge, of which one is GMP-critical, must be maintained and available for inspections. An MHRA preinspection checklist has this as one of its opening topics. The availability or otherwise of this information is a clear indicator of whether management is in control of its computer systems validation. The use of an inventory need not be limited to inspection readiness it could also be used for determining supplier audits and periodic reviews, etc. Many pharmaceutical and healthcare companies use a spreadsheet or database to maintain this data. Where a site s inventory is managed between a number of such applications (perhaps one per laboratory, one for process control systems, one for IT systems), care must be taken that duplicate entries are avoided and, equally, that some systems are missed and not listed anywhere. It should be borne in mind that where spreadsheets and databases are used to manage an inventory, it should be validated just like any other GxP computer application. 

This expectation is exactly the same for any third-party systems used, for example, logistics systems. Organizations can expect regulatory authorities to inquire about whether this topic was covered during the Supplier Audit phase. 

When implementing a metrics system, it is important to ensure the process safety data is reviewed for accuracy. Inaccurate data can lead to poor decisions and focus improper priority to issues. Worse, inaccurate data may focus attention away from serious performance deficiencies. The metrics system designer needs to define the methods that will be used to validate data entered into the metrics system. There are several techniques for validating data many of the techniques have been developed through quality-based efforts and auditing methods. The following is not a detailed how to for developing a validation method, but rather introduces topics for further research. 

The closely related topic of audit reports and sustainability reporting is covered in Section 6.4 of this chapter, entitled Reporting Sustainability Performance. ... 

The number of SOPs and their topics depend on the scope of audits performed, the set up and size of the QA department and whether audits are outsourced to external contractors which may decrease the scope of audits conducted by internal QA members. The QA department may also be tasked with activities such as SOP management and staff training SOPs would also be needed for these areas. 

An opening meeting should be held with the auditee and his/her management, if appropriate, and those responsible for the functions and processes to be audited, in order to confirm the audit plan and the sequence of reviews and topics and to present the audit procedures. The purpose of the meeting is also to confirm that documents to be audited and individuals to be interviewed are available. 

After preliminary planning, permit applications must be completed. Many jurisdictions require a detailed environmental audit, which is then described in a report, often called an environmental impact statement, or EIS. Depending on local regulations, the EIS may be issued for public review and comment. Topics covered in an EIS usually include the following fifteen areas ... 

Critical document reviewis done by the PLL team for documents provided by the government, including reports of unusual occurrences or events, safety reviews (including near-miss advisories), reports of nonconformance or non-compliance, reports of test results, audit surveillance inspection reports, daily and weekly operating reports, and campaign reports. The purpose of these reviews is to identity lessons that will be added to the PLL database, update the database as needed, introduce appropriate topics tor discussion at workshops and, if needed, recommend direct actions to secure further information. 

Therefore, for any given single study, it would be sufficient to address these issues in process-based inspections, and the requirement that each study should be inspected at least once could be fulfilled by the - in any case performed and also for short-term studies necessary - final report audit. Whether it is thus indeed the well-understood intention of GLP that each and every study, however short its duration, and however repetitive and routine its nature, would have to be inspected at least once in order to achieve full compliance, should, with regard to the wordings in the OECD Principles and the respective Consensus Document, not be a topic for debate anymore. 

Bridged Azoalkanes.—The uses of azoalkanes as precursors of biradicals and as synthetic intermediates for the generation of highly bridged hydrocarbons are of great topical interest/ This Report is mainly concerned with synthetic aspects. Reports concerning the chemistry of biradicals that are produced by thermal or photochemical methods or the synthesis of individual azoalkanes will not be further discussed, but such studies concern (82) ° and the alkylated derivatives (83)110,111 (84),"° (85)—(91), " (92), " " (93), " (94) audits analogues, "... 

A recent audit (by the authors) of a number of videos of chemistry presentations given to diverse live audiences in Australia, the UK and the USA showed that most of them are of hour-long shows. They range over a wide variety of topics which include acids and bases, redox reactions, polymers, chromatography, spectra, and so on. The theme in each case appeared to be a focus on astonishing visual or sound effects, rather than on... 

The supplier should prepare presentation material to introduce the QMS, the quality management organization and an overview of the main procedures. The supplier may well be asked to respond to a postal questionnaire prior to an audit on the supplier s premises. This response may even negate the need for an audit of the supplier s premises if information returned fully answers audit questions. Even if an audit visit is still required, a good postal questionnaire response will enable the customer to focus on open topics during the audit, so it is in the supplier s interest to put sufficient effort into the postal exercise. 

In the course of a two-day audit, it is not possible to get a detailed picture of every area to be audited. However, examples of documented evidence that is well defined and required from the audit team should give a sufficient impression of the supplier s quality reliability. The following topics are usually covered in the course of the Supplier Audit. 

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