Supplier Audits organization

A supplier may be contacted informally to discuss the most appropriate audit route, prior to any formal approach being made to conduct an audit. Any proposal or bid made by a supplier should contain the contact details for the quality managers and personnel so that the auditor can easily liaise with the appropriate representative in the supplier s organization to discuss the next steps. When the auditor contacts the supplier to organize an audit, the supplier should also get the auditor s details (full name, postal address, telephone, fax, e-mail, and even video conference details where appropriate) for future communications. 

New owner conduct Supplier Audit on divesting organization as external service provider Formal contract of supply required Service Level Agreement established for maintenance and inspection support... 

Supplier Audits should be conducted where practical for bespoke and critical applications. Emphasis will be placed on the level of support available from the supplier. Remember that the supplier may be a function within the pharmaceutical or healthcare company s organization. In such instances, the Supplier Audit becomes an internal audit and document search. 

When an audit is conducted, the Supplier Audit Report will be the documentary evidence approved by the pharmaceutical manufacturer, which will identify any issues raised during the audit and provide recommendations for any corrective actions. It is expected that these corrective actions will be implemented as part of the approval of the LIMS Supplier/integrator for the project and will form part of the commercial contract between the two organizations. 

All suppliers, system integrators, and consultants contributing to the supply of systems and advice that may impact GxP regulations must be audited. Often the supplier development organization is... 

The Supplier Audit shall establish whether the controls applied to the development of the core product and application confignration are consistent with GxP requirements and whether the organization is technically, organizationally, and commercially capable of supporting the application for its anticipated life. The Snpplier Audit will collate information for review and, where reqnired, corrective action, and determine whether a follow-np andit is reqnired. An example postal andit questionnaire is presented in Table 31.6. The qnestionnaire is not exhaustive. However, it clearly demonstrates the objective and scope of the postal andit. 

Supplier audits must establish whether such contiguration management requirements are implemented by the supplier organization. Experience shows that rarely are all controls applied. However, there is an increasing use of standard contiguration management products that provide access control and modification of software, contiguration, and documentation tiles. 

This expectation is exactly the same for any third-party systems used, for example, logistics systems. Organizations can expect regulatory authorities to inquire about whether this topic was covered during the Supplier Audit phase. 

Central development and support teams should ensure that the quality of suppliers supporting central activities have been assessed. Centrally organized supplier audits should be conducted in conjunction with regulatory groups that are familiar with the organization s operating model. Suppliers supporting local modifications should also be subject to supplier assessment. 

Summary This chapter describes a four-component program of a program to avoid materials mix-ups on your site 1) effective identification of materials and parts in your procurement database. 2) selection of competent suppliers. 3) organization of efficient receiving inspections, and 4) implementing field audit before parts are used. The regulatory background that drives us to avoid materials mix-ups is also described. 

Before utilizing such organizations, the pharmaceutical company must be satisfied that the preferred organizations will meet the technical, regulatory, budgetary and program constraints defined in the project terms of reference. The vehicle most commonly adopted to assess the capability of an organization is the Supplier Audit. 

The audit scope must enable the establishment of a "... high degree of assurance. .." in the supplier organization. A typical scope is presented in Table 2.3. Supplier audits are discussed in more detail in Chapters 14 and 15. 

Supplier Audit Reports should avoid the detailed specification of corrective actions. It is the supplier s responsibility to define how observations will be addressed within the context of the supplier organization and quality systems. 

SAP developed a standard procedure for these Supplier Audits as an offer to customers and prospects coming in to perform an audit. SAP now offers two different events per month to everyone asking for an audit and organizes a joint audit ... 

ORGANIZATION OF A SUPPLIER AUDIT Objective of Supplier Audits... 

The inspection of the capability of the process in order to gain the required assurance as to the fitness for purpose of the developed software—a measure of its validatabillty—is referred to here as a software quality assurance audit. The software quality assurance audit is occasionally referred to as a Supplier Audit (e.g., in the GAMP Guide). However, a Supplier Audit is also used to audit original equipment manufacturers, hardware suppliers, independent contractors and even an internal department with a pharmaceutical organization. There may be no "software" involved at all. For that reason, the term software quality assurance audit is more preferable than Supplier Audit. 

Second party audits are audits of suppliers or potential suppliers undertaken directly by a purchasing organization including the purchase of products by one company from another within the same group. 

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. 

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