Auditors independence

Whether to allow the auditor independent access to people and records, or whether the auditor should always be accompanied by a staff counterpart, who will serve as a watchdog. 

An organisation such as the example above includes sub groups for each of the main activities and a support (or services) group to manage information and procurement. Auditing commitments may be fulfilled by an independent in-house team or by external auditors. 

By being independent of the audited activities, the auditor is unaware of the pressures, the excuses, the informal instructions handed down and can examine operations objectively without bias and without fear of reprisals. It is for this reason that it was considered appropriate for the auditor to have no direct responsibility for the work being audited i.e. audits carried out by a manager, supervisor, or foreman of his/her own department or section do not qualify as internal quality audits in ISO 9001 1994. However, they will qualify under ISO 9000 2000. 

To ensure their independence, auditors need not be placed in separate organizations. Although it is quite common for quality auditors to reside in a quality department it is by no means essential. There are several solutions to retaining impartiality ... 

Separate independent quality audit departments could be set up, staffed with trained auditors. 

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. 

The checklist also serves as a summary of and operationalization of the complex Part 11 requirement. When an auditor—either an independent expert or an FDA investigator—can check as compliant all identified issues, the system is de facto operating under the letter and spirit of 21 CFR Part 11. Any issue that emerges as questionable, unclear, noncompliant, or absent requires investigation, explanation, and remediation. 

The auditors themselves may be obliged to undergo an approval process for independent and high quality work. Since the amendments to REACH are currently on the European political agenda, 2012 would be a convenient time to introduce these three proposals. 

The arm s length approach as a result of lack of funding associated with ethical trade, there is only limited use of third-party auditors. However, the partial use of independent auditors does occur mainly within the context of arm s length relationships between retailers, auditors and suppliers. This can be defined as the contractual relations between companies involving competitive bidding and playing-off of suppliers. Weak social ties and detached social relations are characteristic of such relationships (Doel, 1996, 1999). 

This part of the HACCP plan describes how to verify that the checks are done correctly and that assumptions are met, for example, if an incident has occurred where the critical limits have been exceeded, as well as procedures for handling changes to the product or the process. Another type of verification involves unannounced inspections by independent auditors, which is a requirement for certified schemes. 

An audit is a systematic, independent review to verify conformance with established guidelines or standards. An audit uses a well-defined review process to ensure consistency and allow the auditor to reach defensible conclusions. An audit evaluates the procedures, operations, and activities performed in the management and execution of a program in orderto verify conformity to established criteria. Such evaluations are intended to provide feedback to management and those responsible for the status of the audited program. 

Laboratories can become independently accredited. In this case, accreditation means that some independent auditor has reviewed the laboratory s staff, capabilities, and procedures against some set of requirements and standard practices and judged the laboratory and the workers in the laboratory capable of routinely performing some kind of laboratory work while adhering to those requirements and practices. Some accreditations are for a specific task or for a specific process others are for laboratory work in general. 

Audit Report. A report of an independent audit of the computer validation process by an internal auditor (i.e. Quality Assurance) should be included with the summary report to management. The audit should compare the SOP and the initial parts of the protocol (what the system should do) with the test plan results (what the system actually does) and the summary report conclusions. 

There is an industry trend toward dedicating specific personnel to the function of internal audits and quality assessments. This approach allows the assessor or auditor to focus on the compliance of the company and its vendors and contractors as well as maintain an independent role allowing for impartial assessment of all areas, including the QA unit. Those companies whose assessors and auditors also perform QA responsibilities might seriously consider the regular use of an independent assessment group, such as corporate auditors or an independent consultant. A fresh pair of eyes, coupled with extensive exposure to multiple worldwide operations, makes using external auditors, preferably with some former FDA experience a tremendous asset to any company. 

Only a qualified company of independent experts can give recognition of the Quality System to ISO standards (Quality Audit). The system is subject to ongoing surveillance and assessment of its compliance with the standards. Regular inspection by trained internal auditors is also carried out to assess the company s continued ability to provide products and services of a suitable quality for the customer by asking the following questions ... 

The best way to prepare for an FDA PAI is to perform a mock PAI. The mock inspection is usually best performed by an independent auditor who has re-... 

An internal audit is one undertaken by an auditor who is an employee of the laboratory, usually independent of the area being audited. 

The definition of supplier validation activities and documentation should be embedded in contractual agreements. In addition, suppfiers should agree to potential inspection by GxP regulatory agencies and Supplier Audit by pharmaceutical and healthcare companies. Supplier Audits can be conducted by the pharmaceutical or healthcare company s own personnel or, if this would compromise the supplier s commercial interests, by an independent software quality assurance auditor, consultant, or validation expert employed by the pharmaceutical or healthcare company. Auditors must be suitably qualified, for example by independent certification by examination to the quafity system standards such as ISO 9001 2000. Suppfier Audits are discussed in detail in Chapter 7. 

Audits are usually conducted by an audit team and led by a qualified, accredited auditor. Accredited auditors should have completed a certified development program, be accredited under an appropriate standard (ISO 9000 2000 TicklT in this context), and should have conducted a number of qualifying audits. Pharmaceutical and healthcare companies that do not have their own accredited auditors can engage an independent auditor, as we have seen. Names and addresses of accredited auditors can be found in national registers of certified auditors. The International Register of Certificated Auditors is one such register, associated with the Institute of Quality Assurance (IQA). 

A systematic, independent review to verify conformance with prescribed standards of care using a well-defined review process to ensure consistency and to allow the auditor to reach defensible findings. 

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