Auditing against requirements

There should be complete agreement on the requirements against which the piant is to be audited. For example Will the plant be audited against corporate standards/requirements, piant standards/requirements, or national/internationai standards The standards or requirements used to conduct the audit should be written and published so that everyone is in agreement on expectations. 

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Ensures fundamentid Securky features provided Security functionality audit against requirements for Security Target level Proper implementation of security functional requirements... 

Most certification body auditors who are currently performing audits against one or more of the national automotive quality system requirements (QS-9000, VDA 6, AVSQ, or EAQF) will qualify. To qualify, auditors need to ... 

As ISO/IEC 17025 does not cover some of the system elements, your laboratory should therefore be subject to audit against the relevant requirements of ISO/TS 16949. 

The detail plan for each audit may include dates if it is to cover several days but the main substance of the plan will be what is to be audited, against what requirements, and by whom. At the detail level, the specific requirements to be checked should be identified based upon risks, past performance, and when it was last checked. Overall plans are best presented as program charts and detail plans as checklists. Audit planning should not be taken lightly. Audits require effort from auditees as well as the auditor so a well-planned audit designed to discover pertinent facts quickly is far better than a rambling audit which jumps from area to area looking at this or that without any obvious direction. 

Have external service/support organizations been assessed (e.g., audited) against contract requirements ... 

In the United States, those companies that have adopted Responsible Care are required to use approved third parties to conduct the certification audits at their headquarters and selected facilities. Companies have the option of being audited against ACC s Responsible Care Management System (RCMS ) Technical Specification or the RC14001 Technical Specification, which contains all of ISO 14001 s requirements as well as additional Responsible Care elements. 

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. 

Table 14-1 lists these requirements and provides a record of compliance for future analysis. Requiring completion of this record for each process incident investigated enhances the probability that all elements are covered. Auditing of incident reports against these requirements provides the forum for continuous improvement in meeting compliance requirements. 

After visiting and inspecting the supplier, the information obtained is analyzed against the acceptance criteria, current company requirements for the validation of computer systems, and the regulatory expectations for computing environments. A report is produced that documents the audit process, provides information on the current state of validation of the supplier and what may be needed for compliance and, based on the audit findings, provides a recommendation on whether the supplier can be used. 

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... 

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. 

Validation must demonstrate that the compnter system is able to store the electronic record for the required time, that the data is made readily available in legible form, and that the electronic record is protected against loss or damage. Both technical and procednral controls shonld be vafidated, including audit trail functionality and the snccessful application of electronic signatnres to records. 

Licences to manufacture medicines are granted subject to a satisfactory audit of the manufacturing site against the requirements of the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods (See Appendix 1). Inspections of premises are carried out by members of the Medsafe Compliance Team. The New Zealand Code of GMP is based upon the international standards agreed by the Pharmaceutical Inspection Convention (PIC). 

Protocols that accept electronic inputs such as the sample dilution factor or number of diluents present one additional complication knowing what the instrument actually did. Just as a manual dilution process requires documentation of the various parameters used in the dilution, so does an automated dilutor. This information may be captured in an audit trail, but it is generally necessary to store this information with the assay documentation where it can easily be cross-checked against the parameters in a LIMS. This creates a requirement for the automated dilutor to generate a report of sample IDs, actual dilutions performed, number of... 

Every laboratory striving for perfection needs to do periodic audits to check that its quality systems are still working properly. Audits of test methods should be conducted (perhaps annually) to confirm adherence to the documented test methods. The performance of the entire test should be observed and checked against the official specified test method. Many errors in results are derived from taking liberties with the test method s detailed requirements. 

Compliance with the requirements of ISO/IEC 17025 2005 is essential if a laboratory is to become accredited for particular analytical procedures. External audit by a recognized national or international body is a prerequisite for this process. For example, in the United Kingdom, accreditation is awarded by the UK Accreditation Service (UKAS) and in Canada by the Standards Council of Canada. The benefits of accreditation will be discussed in more detail below, but accreditation for a particular function by a recognized body means that the laboratory has been assessed against internationally recognized standards to demonstrate their competence, impartiality, and performance capability. 

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