Auditor internal

Environmental auditors (internal or external) must have the authority and means to access, compile, evaluate and report the required information... 

Requirement for compliance with customer requirements for internal system and process auditor qualification... 

The auditor should verify that all elements have been subject to internal audit during the initial audit and, if not, a nonconformity is warranted. 

You will need to provide lists of qualified internal auditors, customers, and their specific requirements with your application for certification. 

It should be recognized that there is no requirement for auditors to be trained as Lead Assessors or Registered Internal Quality Auditors. Staff need only to be trained sufficient to carry out the task given to them. 

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. 

Customers are likely to require internal auditors to at least have taken an Internal Auditor Training Course that meets the requirements of ISO 10011 but are unlikely to require Lead Auditor Registration. VDA 6.3 on Process audits requires the auditor to have at least two years practical experience in process management in the automotive industry and to have performed at least three process audits with the support of a technical expert from the process area. 

Most large organizations, particularly in central and local government, have set procedures in the form of standing orders, and this area is usually of most interest to internal and external auditors. The object of inviting competitive bids is to obtain the lowest price for the job, based on a fair method, which enables every bidder to bid for the same thing. 

In addition, a system for making sure staff are appropriately qualified and trained for the work that they are doing must be in place. This will enable an auditor to see clearly the demonstrated competence of the staff and how this has been checked. The requirements for all major items of equipment must be listed, to ensure that the equipment in use is suitable for the task, is in working condition and, where necessary, is calibrated. For all of the instrumentation there needs to be a documented schedule for maintenance. Measurements must be traceable, that is, the laboratory must be able to show how the calibration of measurement instruments is traceable to National or International Standards. Where this presents practical problems, as in some chemical measurements for example, interlaboratory comparison and the use of reference materials (and preferably Certified Reference Materials) will be required. 

To ensure that all aspects of the laboratory s activities are covered over a set period of time, a spreadsheet of activities can be prepared. This shows when each area is due for audit. In order to have a consistent approach, a check-list approach may be adopted. An example of a check-list of aspects which should be examined as part of an internal quality audit is shown in Table 9.5. This can be used as the basis for an audit against any of the Standards already mentioned in this chapter. Not all of the parts will be appropriate for all of the Standards. Table 9.7 expands on what is included in Table 9.5 and can be used to remind auditors and laboratory staff of the things that can affect the quality of a result. 

Audits and Corrective Actions—Items considered are process safety audits, maangement system audits and compliance reviews (criteria for intemal/extemal reviews and auditors for external/internal reviews), and resolutions and close-out procedures. 

For example For contract work an anditor comes to the laboratory and checks whether the staff perform the task according to (agreed) standards, utilising appropriate laboratory equipment correctly. This is also called assessment or external audit. Internal auditors can be colleagues (from a different laboratory in the same company or a different working area). Reviews are usually carried out by upper level managers. 

The internal audit is performed by qualified internal auditors who are members of the organization. However, auditors should not audit their own work. 

During the audit process the auditors inspect the effective and efficient implementation of the laboratory processes, the capability of processes, the performance results, the improvement activities and they are also looking for opportunities for improvement. The aim of the internal audit is to determine whether the quality management system conforms to the planned arrangements and if it is effectively implemented. 

The internal audit procedure is documented and it has to be understood both by the auditors and those being audited. The objective of the internal audit is to contribute to the improvement of the organization via the elimination... 

As databases were automated that review function became increasingly problematic, and increasingly a concern of both outside FDA and internal QA auditors. As a response to the difficulty in tracking a data point change in an electronic file automated audit trails were developed, encouraged, and finally (in Part 11) required. 

Gilhooley lA. Improving the relationship between internal and external auditors. J Acc EDP 1 (1) 4-9, Spring 1985. 

Morris R HI. The internal auditors and data processing. Internal Aud Aug. 1978. 

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. 

Training, or arranging the training, of all personnel selected to be internal auditors. 

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 ... 

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. 

A quality manual has to document those procedures and policies that are carried out in the laboratory that can affect an analysis. In addition details of the organisational relationships, responsibilities and authorities of all of the more senior staff and the internal auditors are described. The manual will probably include descriptions of the resources of the laboratory, examples of records used, calibration and audit schedules, and routines such as the periodic review of the quality system. 

---