External audits

Aud/f/ng the operation of a system may be done by an external audit team composed of qualified people from within or outside the operating company. However, involvement... 

The external audit results are used to determine the accuracy of the measurements. Accuracy is calculated from percentage differences, dj, for the audit concentrations and the instrument response. 

The differences with the existing automotive quality system requirements need careful examination. There are additions, deletions, and movements that users of QS-9000 Third Edition, AVSQ 94, EAQF 94, and VDA 6.1 1998 need to be aware of, as they affect not only supplier quality systems but the internal and external auditing practices. As the national requirements are not similarly structured comparisons are impossible to illustrate in a single table. Readers are therefore advised to compare specific text in each to discover the actual differences. The source of the requirements is depicted in the tables that follow. A dash (-) indicates that there is no matching requirement. 

Your corrective action procedures need to cover the collection and analysis of product nonconformity reports and the collection and analysis of process data to reveal process nonconformities. The corrective action provisions of your internal audit procedure need to address the causes of the nonconformities and you will need an additional procedure to deal with external audits, investigating the cause of any nonconformities and recording the results. The procedure also needs to cover the investigation of customer complaints as the previous requirement only deals with the handling of complaints. 

External audits carried out by second or third parties. They include a documentation audit, implementation audit, and the determination of the effectiveness of the system. 

External audits carried out by personnel who are neither employees of the customer nor the supplier and are usually employees of certification bodies or registrars. 

Peer review This involves setting up mechanisms for mutual review of dmg regulation systems. It serves as a means of external auditing, whereby the performance of one agency can be compared with that of others. Systems for international peer comparison of QC laboratories are one example. Proficiency tests are performed by the participating laboratories in such a way that each laboratory learns how well it is performing in comparison with the others. 

Each area of operation should be audited periodically, usually once every twelve months. However, new areas may be audited on a more frequent basis. Ideally, they are planned mid-way between external audits. This process should be planned well in advance and written down in the Quality Manual as a structured audit programme, covering both the timing and the coverage of the audit process. The audit programme can be of two types, either ... 

Results from external audits (second- and third-party)... 

External audit Audits conducted by external independent organizations (third-party audits) or by persons having an interest in the organization, e.g. customers (second-party audits). 

It is necessary to ensure suppliers of materials have in place appropriate quality systems and that they are reliable. External audits may be required to inspect and confirm the supplier s facility and quality system. 

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. 

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). 

The frequency of the validation review should be addressed in the final validation report and may be determined against elapsed time or the number of batches processed, anomalies in results of in-process and end-product testing, and questions arising from internal or external audits. 

The organization has ensured continual improvement in the effectiveness of the quality management system through management review (measurement and analysis), internal and external audits, and corrective actions. 

A well-conducted program of internal self-audits is important to a site s overall safety and loss prevention efforts. The discussion in this section is applicable to internal audits as well as to external audits conducted by audit teams from other Dow units. 

It should therefore be clear that the protocol is a key communication tool not only for the owner, but also for internal and external auditing parties. As a communication tool, the protocol should be capable of completely informing the reader of every critical thing that happened—from beginning to end—within the activity. 

Requires a commitment on the part of the purchaser to an external audit for GMP and/or ISO 9000 compliance Requires more internal quality control on the part of the purchaser beyond certificate of analysis acceptance... 

The performance of the laboratory QC system is assessed through internal and external systems audits. Laboratory QA section performs internal audits and identifies the weaknesses of the quality system or the deviations from approved internal procedures. The state, the EPA, a client or any other body that oversees the quality of laboratory work conducts external audits as part of initial and ongoing laboratory... 

Only experienced quality auditors, such as the chemists who are knowledgeable in the analysis being audited, should conduct external audits. Audit findings give rise to corrective action that is implemented and documented by laboratory operations personnel. However, even the most detailed and frequent audits may be ineffective in disclosing data fraud (Popek, 1998b). External audits are expensive and are usually conducted for government project or major industry client work. 

External audits of raw material suppliers and contracted services should be handled in much the same way as the internal QAP. Audit protocols should be customized and tailored to the specific organization to be audited. For example, an assessment of a contract laboratory service should be conducted under the auspices of the internal audit team and follow similar procedures in terms of identifying deficiencies, installing corrective and preventative measures, and reports issuing. It is an advantage to employ the same personnel for both the internal and external audits. This approach assures a standardized and uniform audit procedure across the board. 

Most companies have set in place procedures to meet the requirements of the international quality standard e.g. ISO 9001 or national equivalents, as discussed in Section B, 3.2.23. The requirement of these standards are that procedures are in place for all activities carried out in the workplace, that these procedures are recorded and that the activities are carried out, by staff, as described in the procedures. The operation of these procedures is subject to an external audit, to confirm that there is compliance in the day-to-day activities of a work group. It should be noted that having procedures written down does not necessarily mean that an organisation has the best procedures in place. They will need to be constantly monitored and modified in the light of experience. 

Subject to external audit, the industry has agreed to work towards these limits from 1998 for VCM and S-PVC, and 2003 for E-PVC. 

Assessor Audit schedule Audit trail External audit Horizontal audit Internal audit... 

An external audit is one carried out by an auditor external to the laboratory. This may be a representative of an accreditation or certification body or possibly a client. 

Internal and external audits will be examined, usually annually, to check that the quality system meets current needs and/or that the procedures arc being implemented. This formal process is known as management review. 

In order to demonstrate its compliance with the standard a laboratory will normally apply to an external accreditation body or certification body for accreditation or certification against tbe standard. Certification involves confirmation that the quality management system in place in the laboratory is fully implemented and in compliance with the requirements of the standard. Accreditation, however, adds a further element and involves a peer review of the methods used by the laboratory to confirm that they are suitable for the purpose for which they are being offered. Certification involves checking that what is described in the quality manual is carried out, i.e. an external audit (see Section... 

Quality assurance is not just a process it is a way of thinking. All staff should be well trained and motivated and be working to a common goal the production of a pharmaceutical product of a quality that is safe for the patient. The procedures should not be seen as a chore or burden to make work more difficult, but essential steps in the production of a safe, satisfactory product. Self-inspection and external audit of procedures are important processes in maintaining standards of cleanliness. Even after manufacture and distribution it is vital that the products are used properly, especially multi-use containers that are subject to potential in-use contamination. 

At the same time, internal quality control must be carried out to verify the performance stability of the limited-scope performance of the method. Triply redundant verification methods are carried out with regard to control of first, second and/or third line, each set of methods applied to a particular type of test. The first line of verification involves pro forma repetition of all the steps of the test, in order to establish repeatability or reproducibility for quantitative tests, and to verify the range of sensitivity or detection for qualitative tests. This verification is performed by the experimenter himself, as part of the proper performance of the test. A second line of verification is put into operation by administrative decision, and includes testing with blind samples, repetition of samples, internal audit procedures, etc. If necessary, a third line of verification can be set up by the use of certified reference materials (or spiking materials), or through collaborative trials. These procedures are based on external cooperation. External audit procedures and complaints handling procedures are also part of this third line of verification. 

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