Compliance conducting audit

The primary impetus for the maintenance of compliance, however, is the regular external inspection by the Inspectorate. In addition, it is now becoming frequent for independent consultants to be brought in to do preregulatory inspections. Whichever way one views the system, whether through consultation or by assigning a department to perform inspections in one area and to conduct audits in another, the regular review of compliance should be maintained. 

The quality assurance department within a company will frequently conduct audits of investigator sites, either during a clinical study or after it has been completed. Companies that do not have a quality assurance department or unit may contract this service from a consultant or a third party specializing in regulatory audits. The intent and scope of these audits are the same as the FDA, but they afford a company an opportunity to verify compliance and to correct deficiencies that might otherwise delay product approval. These audits... 

A trained individual or team should audit the PSM program and evaluate the system s design and effectiveness. Companies are required to conduct audits every three years to ensure that they are in compliance with the PSM regulation. These audits may be conducted by the company s corporate personnel, sister company personnel, or in-plant personnel. Prompt response to audit findings and documentation that deficiencies were corrected are required. 

PPE (personal protective equipment) subteam This team can ensure that PPE requirements are defined for the different tasks within the plant and then conduct audits for compliance. When new equipment or processes are brought into the plant, they can assess the PPE required. Noise abatement subteam Annual noise level audits, annual hearing testing, and defining the need for sound enclosures would fall within the scope of this team. 

Compliance of the safety process to laws, regulations, and company policies and procedures is measured effectively by audits. Self-audits can be effective, if done with objective honesty. More than 85 percent of employers in a recent Occupational Safety and Health Administration survey said they conduct voluntary self-audits of safety and health conditions in their workplaces (HE Solutions 1999, 12). With a 60% increase over an 18-year period in the number of organizations indicating they conduct audits, nearly 90 percent of the respondents indicated they had conducted an audit in the past 12 months (HE Solutions 1999,12). Reasons for conducting these audits include the need to reduce accidents, to do what is considered right for worker safety and health, and to ensure OSHA compliance. Additional motivators for organizations to conduct audits include decreases in injury rates, improvement in insurance rates, and mitigating fines from OSHA violations. 

Conduct audits of regional/facility HSE compliance and assessments of program implementation efforts. 

An important aspect of environmental, health, and safety laws and regulations is enforcement. Eederal, state, and local regulatory authorities usually have large enforcement sections. In the environmental area, compliance audits are usually conducted aimually. OSHA, both federal and state, usually audits based on a faciHty s accident/incident rate. 

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. 

ISO 9000 is not a statutory requirement and neither is certification, hence certification is voluntary. However, suppliers may be under pressure to obtain registration to ISO 9001, ISO 9002, or ISO 9003 in order to tender for contracts. Within the ISO 9000 certification scheme, the certification industry is regulated by accreditation bodies. An International Accreditation Forum (lAF) attempts to harmonize accreditation practices world-wide through ISO Guide 61. The accreditation bodies authorize certification bodies to conduct certification to prescribed standards - a process that is called accreditation. The accreditation body performs witness audits and desk audits of the certification body to ensure compliance with the conditions of accreditation. 

All audits should be conducted against a standard for the performance being measured. Examinations without such a standard are surveys, not audits. Audits can also be conducted against contracts, project plans, specifications - in fact any document with which the organization has declared it will comply. The standard now requires system audits to be conducted to verify compliance with ISO/TS 16949 and any other system requirements. 

Because of the complexity of computer hardware and software and because of the intricacy of a risk assessment, the FDA has to all intents and purposes adopted an indirect regulatory posture. Regulated companies are informally urged to conduct independent audits of Part 11 compliance, utilizing in-house or consultant expertise. The agency can then review the details of the audit report and the credentials for experience, expertise, and independence of the auditor. Follow-up investigation of speciflc points can then be laser-focused on specific areas of concern. 

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

Auditing data that have been captured, manipulated, transferred, and reported electronically has produced new challenges for QA personnel. In general, auditing electronically captured data from studies conducted in compliance with GLP should be approached no differently than performing any other data audit however, there are additional considerations. 

All audits should be conducted to ensure coverage of and compliance with the appropriate Standard, e.g. ISO/IIiC 17025 2005 and ISO 9001 2000. 

The Full Inspection Qption is a surveillance or compliance inspection that is thorough and gives the FDA a deep understanding of the cGMP program in a manufacturing facility. This type of inspection is conducted when the FDA has little knowledge about the facility, such as a new facility or where the facility has a history of noncompliance or when the FDA has doubt about the facility s quality system. The Full Inspection Qption audits at least four systems in the facility, one of which must be the quality system. 

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. 

The Aimex I of the Directive 2004/9/EC consists of two parts Part A (Guides for compliance monitoring procedures for good laboratory practice) and Part B (Guidance for the conduct of test facility inspections and study audits). The provisions for the inspection and verification of GLP which are contained in Parts A and B are those contained in Annexes I and II respectively of the OECD Council Decision-Recommendation on comphance with principles of good laboratoiy practice. 

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. 

Could regulators conduct their own audits, not depending upon validation by laboratories In theory that strategy could be successful, but two problems stand in the way. First, resources, including time and expertise, permit only a very cursory spot check on compliance. Those limited resources are much better spent in reviewing comprehensive validation reports than in conducting very limited tests of system performance and compliance. 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

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