This advisory supersedes any previous version.

It is considered part of APIs Program Requirements and is compulsory.

Advisory 3 J anuary 27, 2006 An equal opportunity employer


API Certification Programs
1220 L Street, Northwest
Washington, DC 20005-4070


ADVISORY 3
Recognition and Authority of Management Representative

This advisory describes APIs 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 quality
management system and the personnel responsible for maintaining the system have
the necessary competency and are actively engaged in the process, as well as, to
verify manufacturing / service provision capability. In order for API to properly
evaluate a facility, it is extremely important that API and its auditor(s) have direct
communications with the personnel that are responsible for handling the quality
management system issues at the facility on a daily basis.

The Management Representatives of licensed and certified clients must be appointed
by the organizations 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, do
not satisfy this requirement.

It is acceptable for consultants to be present during audits. They cannot, however,
act as the organizations management representative or interfere with the progress of
the audit. Authorized observers may attend the audit, but they may not influence or
interfere 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 not
while interviews are being carried out.
Provide clarification to the needs of the auditor, relating API audit requirements to
the audited client in terms that the client may understand with respect to their own
quality 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 for
understanding 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 is
not currently implemented in the organizations quality management system as
evidence of compliance with program requirements.