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directly involved in all of the reconditioning activities, having an auditor independent of
the process could be unduly burdensome or impractical. Under such circumstances, the
requirement for independence may be waived. However, if DSHS finds, as a result of
inspection or by other means that this waiver has compromised the quality system, DSHS
may require that future audits be performed by individuals independent of the process,
increase the frequency of DSHS inspections, or take other appropriate regulatory action.
Individual(s) responsible for conducting audits should be sufficiently trained and
experienced to detect variations and problems in the quality system. As with any quality
system related training, a record shall be maintained of the audit training given each
employee. An auditor is expected to objectively compare existing employee training,
reconditioning processes, facilities, environmental control, device master records, device
history records, test/inspection activities, equipment calibration system, label control
systems, feedback, etc., against what they should be. To do this, the individual(s) should
have a working knowledge of:
! the reconditioning process,
! all process controls activities,
! knowledge of how changes are controlled, and
! the quality assurance principles that apply.
Because audit results require documentation, auditors should have sufficient writing
skills to
effectively communicate their findings and recommendations to management. The
effectiveness of the audit begins with the audit planning. Management should start by
defining the purpose and scope of their audit, while keeping in mind their quality systems
requirements. Auditors should be identified early in the planning process. The auditors
should possess skill and knowledge of quality system principles. Preparing an audit
checklist or worksheet will help to ensure that the auditor covers all of the quality system
requirements. Review of previous audits and their resulting reports is an excellent way
for the auditor(s) to correctly evaluate their quality system audit program. The
background preparation should also include becoming familiar with company policies,
operations, and the types of medical devices that are reconditioned. The auditor(s) should
notify the parties they will audit and, if there are several auditors involved (an audit
team), then the audit team should hold a pre-audit conference among the audit team
members to clarify exactly what the audit will include and what the objective(s) of their
audit will be. Thus, preparing for an audit should include elements such as:
! selecting a knowledgeable auditor or audit team,
! preparing an audit checklist or worksheet,
! developing a planned and systematic audit procedure,
! structuring the audit to determine both positive and negative trends, and
! structuring the audit and report to promote follow-up actions.