8/12/2019 Advisory 3 - Recognition and Authority of Management Representative

http://slidepdf.com/reader/full/advisory-3-recognition-and-authority-of-management-representative 1/1

This advisory supersedes any previous version.It is considered part of API’s Program Requirements and is compulsory.

 Advisory 3 January 27, 2006 An equal opportunity employer  

 API Certification Programs1220 L Street, NorthwestWashington, DC 20005-4070 

 ADVISORY 3Recognit ion and Authority of Management Representative

This advisory describes API’s position on recognition and the authority of“management representatives” of licensed and registered organizations.

The purpose of the audit is to verify that the facility has implemented the qualitymanagement system and the personnel responsible for maintaining the system havethe necessary competency and are actively engaged in the process, as well as, toverify manufacturing / service provision capability. In order for API to properlyevaluate a facility, it is extremely important that API and its auditor(s) have directcommunications with the personnel that are responsible for handling the qualitymanagement system issues at the facility on a daily basis.

The Management Representatives of licensed and certified clients must be appointedby the organization’s top management and be employed by the organization on a full-time basis. Consultants hired on a contract or temporary basis, as a general rule, donot satisfy this requirement.

It is acceptable for consultants to be present during audits. They cannot, however,act as the organization’s management representative or interfere with the progress ofthe audit. Authorized observers may attend the audit, but they may not influence orinterfere with the conduct of the audit.

During an API audit, consultants can:

•  Provide support to the audited organization during the course of the audit, but notwhile interviews are being carried out.

•  Provide clarification to the needs of the auditor, relating API audit requirements tothe audited client in terms that the client may understand with respect to their ownquality management system.

During an API audit, consultants cannot:

•  Claim to be the point of contact for the audited organization.

•  Coach interviewees during an interview (other than providing clarification forunderstanding – see above).

•  Directly answer questions posed by the API auditor for the organization.

•  Provide new or revised documentation during the performance of the audit that isnot currently implemented in the organization’s quality management system asevidence of compliance with program requirements.