Audit product/service

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. 

A.4. Summary of product/service under audit (product literature)... 

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. 

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... 

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. 

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. 

The process audit to verify that the result-producing processes control products and service within the defined limits. This is now required in ISO/TS 16949 clause... 

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. 

We five in the age of quality. Quality is measured, analyzed, and discussed. The simplest product and the most trivial service come from quality-assured organizations. Conspicuously embracing quality is the standard of the age. Even university faculty are now subject to quality audits of their teaching. Some of these new-found enthusiasms may be more appropriate than others, but I have no doubt that proper attention to quality is vital for analytical chemistry. Analytical measurements affect every facet of our modern, first-world fives. Health, food, forensics, and general trade require measurements that often involve chemical analysis, which must be accurately conducted for informed decisions to be made. A sign of improvement in developing countries is often a nation s ability to measure important aspects of the lives of its citizens, such as cleanliness of water and food. 

This safety audit is used for identifying inputs and material flows, processes and intermediates, and final products - but with special attention paid to human-material/process/equipment interactions that could result in (a) sudden and accidental releases/spills, (b) mechanical failure-based injuries, and (c) physical injuries - cuts, abrasions, and so on, as well as ergonomic hazards. Additional sources of adverse effects/safety problem areas are records/ knowledge of in-plant accidents/near misses, equipment failures, customer complaints, inadequate secondary prevention/safety procedures and equipment (including components that can be rendered non-operable upon unanticipated events), and inadequacies in suppliers of material and equipment or maintenance services. 

The purchaser should verify that the supplier of raw materials, components, and services for the manufacture of excipients has the capability to consistently meet the agreed-upon requirements. This may include periodic audits of the vendor s plant, if deemed necessary. Purchasing agreements should contain data clearly describing the product ordered, including where applicable, the following ... 

All relevant departments are provided with adequate resources and trained personnel for the activities related to product realization including inspection, test, monitoring of the design, production, installation, and servicing of the process and/or product. Verification and audit activities are carried out by personnel independent of those having direct responsibility for the work being performed. 

DHS. 1989. Waste Audit Study Fabricated Metal Products Industry. Department of Health Services, Toxic Substances Control Division, Alternative Technology Section. Prepared by Jacobs Engineering Group. Contract No. 87-T0096. 

PDA Technical Report 32. Auditing of Suppliers Providing Products and Services for Regulated Pharmaceutical Operations. International Association for Pharmaceutical Science and Technology (1999). 

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

Auditing of Suppliers Providing Computer Products and Services 32 1999... 

Prior to a site visit, assess the vendor remotely through product literature and submission of a preaudit questionnaire. When a vendor site audit becomes necessary, plan the audit s scope and focus and identify the audit team. Audit team members should include user group lead, information services groups (IT/IS/MIS), compliance, purchasing, and validation personnel. 

---