Service audit

The product or service audit to verify that the resultant products and services meet the prescribed requirements. This is now required in ISO/TS 16949 clause 4.17.2.4. VDA 6.5 provides guidance. 

Finished product manufacturing Commercial packaging Adverse event data management Validation services Auditing services... 

QA programme Organization Document control Design control Procurement control Material control Process control Inspection and test control Non-conformance control Corrective actions Records Staff training Servicing Audits... 

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. 

It is also a guideline to ensure product quahty through the suitabihty of the manufacturing equipment, air and water quahty, sanitation, insect and rodent control, and housekeeping. The FDA periodically sends inspectors to audit chemical companies who manufacture bulk pharmaceutical chemicals or inactive ingredients called excipients to ensure conformance. Whereas GMP conformance ensures that the product meets pharmaceutical quahty standards, it does not ensure conformance to customer-service-related requirements. 

A postproject management audit (project audit) is performed to verify that project terms were carried out and that services contracted for were satisfactorily completed. Once these basic objectives have been achieved, it is important that all documents are properly assembled and the project file be closed and stored in a manner permitting rapid reference and retrieval. 

To receive ISO 9000 accreditation, a certification body must meet the requirements of ISO Guide 62 and EN 45012, which invokes ISO 10011. There is normally a mark of accreditation (a Grown and Tick in the case of UKAS accreditation) that certification bodies use to signify their credibility. Once accredited, a certification body may perform audits on suppliers offering products and services within the scope of accreditation. In theory, accreditation is granted only if the certification body has expertise (i.e. competent auditors) for the particular industry sectors (EAG codes) requested. 

Knowledge that the products and services meet your requirements. (This may be gained by personal assessment or reliance on independent audits.)... 

The scope of certification shall include all products supplied to customers subscribing to the certification of ISO/TS 16949. A supplier cannot exclude products and services from the audit scope if any such products and services are provided to subscribing members - hence the auditor needs to know who the subscribing members are. 

By producing defining specifications that prescribe requirements for products or services and also the means by which these requirements are to be verified in-house in terms of the inspections, tests, analyses, audits, reviews, evaluations, and other means of verification... 

The document availability requirement applies to both internal and external documents alike. Customer documents such as contracts, drawings, specifications, and standards need to be available to those who need them to execute their responsibilities. Often these documents are only held in paper form and therefore distribution lists will be needed to control their location. If documents in the public domain are required, they only need be available when required for use and need not be available from the moment they are specified in a specification or procedure. You should only have to produce such documents when they are needed for the work being undertaken at the time of the audit. However, you would need to demonstrate that you could obtain timely access when needed. If you provide a lending service to users of copyrighted documents, you would need a register indicating to whom they were loaned so that you can retrieve them when needed by others. 

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

They mainly apply to products as most of them are concerned with protecting the product from damage and deterioration. They apply to the end product and any items that either form part of the product or are used to produce the product, including any tools, test equipment, and processing materials. Although it is possible for some types of services to deteriorate, this use of the term preservation is covered by the process control and auditing requirements. The only requirements that do apply to services are those for identification, unless product is used in the delivery of a service. If the servicing is done to a product, whether or not the product is owned by the supplier, protection of that product is important. 

Customer complaints Warranty claims Failure analysis reports Process capability studies Service reports Concessions Change requests Subcontractor assessments Performance analysis Deviations and waivers Contract change records Quality cost data External Quality Audit records... 

The requirements for internal audits apply to audits of the quality system, including the policies, practices, products, and services to which the quality system relates. They are not limited to audits of procedures. In order to determine whether the quality system is effective in maintaining control, you need to check that the resultant products and services meet the specified requirements and that prescribed quality objectives are being achieved. If the products and services are not meeting the specified requirements, or the prescribed objectives are not being achieved, something is clearly amiss with the quality system. The requirements do not apply to audits of suppliers or subcontractors as they are covered in clause 4.6 of the standard. 

The related results are the results produced by implementing the policies and procedures. They include documents, decisions, products, and services. It is not enough for internal audits to verify that procedures are being followed. They need to verify whether the outputs of these procedures comply with the prescribed requirements. 

On the importance of the activity, you need to establish to whom is it important to the customer, the managing director, the public, your immediate superior You also need to establish the importance of the activity upon the effect of noncompliance with the planned arrangements. For example, not ordering the correct grade of steel may only delay fabrication if you are lucky but, if not detected in time, may result in the component failing in service. Getting the purchase specification correct is important so this activity should be audited. 

Objective evidence of the achieved features and characteristics of a product or service and the processes applied to its development, design, production, installation, maintenance, and disposal as well as records of assessments, audits, and other examinations of an organization to determine its capability to achieve given quality requirements. 

A special investigation, test, inspection, audit, review, demonstration, analysis, or comparison of data to verify that a system, product, service, or process complies with prescribed requirements. 

The aforementioned reviews and assessments were assimilated to characterize the effect of dielectric, rotational, and mechanical hazards on motor performance and operational readiness. Functional indicators were identified that can be monitored to assess motor component deterioration caused by aging or other accidental stressors. The study also includes a preliminary discussion of current standards and guides, maintenance programs, and research activities pertaining to nuclear power plant safety-related electric motors. Included are motor manufacturer recommendations, responses from repair facilities to a questionnaire, in-service inspection data, expert knowledge, USNRC-IE audit reports, and standards and guides published by the Institute of Electrical and Electronics Engineers (IEEE). 

Energy audits are also leveraged with a system commonly called over the fence energy. In this scheme, the end-user does not buy equipment, but purchases a commodity such as steam, heat, or compressed air from a third party. The third party owns, leases, or operates the equipment used to provide the energy service. It is then in the interest of that third party to ensure that energy audits are routinely carried out and unnecessary energy use is kept to... 

The Audit Commission for England and Wales promotes proper stewardship of public finances and helps local authorities and the NHS to deliver economic, efficient and effective public services. The Commission also owns District Audit, which it appoints to carry out many of the audits for which the Commission is responsible. District Audit operates as an arm s-length agency. 

Ludington, D. and Johnson, E. L. (2003). Dairy Farm Energy Audit Summary Flex Tech Services. New York State Energy Research and Development Authority, Albany, NY. http //www. nyserda.org/publications/dairyfarmenergysummary.pdf. (accessed 24.10.10). 

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