SAMPLE COMPANY                                        Page 1 of 5
SOP # 17-1  Revision: 0                Prepared by:             _
Effective Date:                        Approved by:             _


Title:         QUALITY ASSURANCE AUDITS

Policy:   Quality Assurance is an integrated effort or total
          systems approach to satisfy the quality, performance
          and safety for each product and usermarket.  It does
          not simply consist of inspection and testing, or spot
          solutions or "fire fighting".  To evaluate and
          continually improve Quality Assurance, periodic and
          unscheduled audits of completed products, processes and
          product flow shall be performed to assure compliance
          with regulatory and company requirements.


Purpose:  To describe the Quality Assurance Audit process and
          corrective action as a vital component of the total
          quality assurance system.

Scope:    All production and manufacturing operations.


Procedures:

1.0  Audit Guide

1.1  Routine quality audits of selected areas shall be conducted
     at the discretion of the Quality Assurance Manager.  An
     "Action Audit" may be performed more than once and any time
     a special problem arises.  A routine audit must be performed
     a minimum of once in a twelve month cycle.

1.2  The Quality Assurance Manager may appoint an audit team to
     assist with identifying and correcting deficiencies.  If an
     audit team is used, it shall consist of the Quality
     Assurance Manager (team leader) plus one or more individuals
     from other areas with no direct responsibility to the area
     being inspected.

2.0  Audit Process

2.1  Audit Preparation:  The audit team should review good
     manufacturing practices, master product records, product
     history and complaint files plus any other documents
     relevant to the audit.

2.2  Audit Initiation:  The Quality Assurance Manager will
     prepare the Quality Assurance Audit Checklist (Exhibit 1) to
     assure a systematic examination of the department or area.
     The Quality Assurance Manager will inform the area manager
     at the start of the audit and will review any observations
     made.
QUALITY ASSURANCE AUDITS                              Page 2 of 5


2.3  Audit Report:  The Quality Assurance Manager will review the
     data gathered and verify important details.  A written
     report will be issued to the Vice-President of Operations
     and the department manager within five (5) days of
     completion of the audit.  If conditions are critical, the
     Quality Assurance Manager will verbally address the
     appropriate manager within one (1) working day after the
     audit to discuss and implement corrective action or
     interruption of operations until corrective action can be
     implemented.

     The audit report should be in the following outline:


     a.   Purpose and area description - Describe initiating
          factors for the audit, limitations of audit, and area
          being audited.

     b.   Major facts - Summarize for management review, the most
          undesirable conditions and practices in order of their
          relative importance.

     c.   Observations and deficiencies - Give a detailed account
          of the current practices and list the deficiencies in
          procedures, standards, documentation, safety, etc.,
          along with identity of relevant regulation or ISO 9001
          Standard.

     d.   Follow-up - State plans for follow-up review to
          establish individual responsibilities and completion
          dates.



3.0  Corrective Action

3.1  If deficiencies in quality assurance are discovered during
     the audit,  the department manager or an individual
     designated by the manager, will submit a corrective action
     program within five (5) working days after notification.
     The corrective action program should sufficiently address
     all areas described with adequate measures to resolve the
     issues.  The Quality Assurance Manager may challenge the
     validity of a corrective action program.  In this situation,
     the department manager should prepare a written statement
     directly addressing the specific area and submit it to the
     Vice-President of Operations and the Quality Assurance
     Manager.  The Vice-President of Operations will in this
     situation represent final arbitration.
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4.0  Audit Records

4.1  The Quality Assurance Manager will maintain a master log of
     audits listing deficiencies, individual with assigned
     responsibilities, target correction date and mandatory
     completion date.  If conditions dictate, administrative
     action may be taken if directed by the Vice-President of
     Operations.

4.2  The master log of audits shall be maintained and in the
     possession of the Quality Assurance Manager.  The audit log
     file shall include a copy of the most recent audits with a
     minimum of one (1) audit per department and a listing of
     projected audits and tentative dates (month and year).  All
     audit reports and the master log will be available for
     inspection by regulatory authorities, otherwise these
     records are classified as confidential on  a "need to know"
     access basis.  Access to reports must be requested and
     approved from the Quality Assurance Manager in writing.