SAMPLE COMPANY                                       Page 1 of 10
SOP # 04-2  Revision: 0                Prepared by:             _
Effective Date:                        Approved by:             _


Title:         PREPRODUCTION QUALITY AND PLANNING

Policy:   Intrinsic "quality" is the inherent quality designed
          into a product and the associated manufacturing
          processes.  "Achieved" quality is assured through
          procedures for orderly transfer of the design
          information into the production department followed by
          controlled manufacturing of the product.

          It is the policy of the company that programs and
          procedures will be developed and continually maintained
          and redefined for assuring that appropriate
          preproduction activities are correctly performed that
          will result in the orderly development and transfer
          into production of a new or modified product.


Purpose:  This procedure outlines the steps, planning and reviews
          for implementing the orderly transfer of a new or
          modified product upon completion of its design phase
          into full-scale production.

Scope:    This procedure applies to all departments and
          individuals involved with the development and release
          of a new or modified product prior to full-scale
          production.


Contents:

     1.0 - Design Completion

     2.0 - Design Transfer and Documentation

     3.0 - Production Plan


Procedures:

1.0  Design Completion

1.1  Upon satisfactory completion of the design phase of a
     product, final evaluation of a prototype will be performed
     and changes, modifications or corrections completed prior to
     transferring the product into production.
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     For electromechanical products, a Design Completion
     Checklist For Electromechanical Devices (Exhibit 1) should
     be completed and evaluated.  For non-electromechanical
     products a Design Completion Checklist for Non-
     Electromechanical Devices (Exhibit 2) should be completed
     and evaluated.

1.2  The design completion phase also will encompass evaluating
     that the product satisfies all regulatory requirements in
     all markets (domestic and international) that the product
     will be sold.  Further, applications for any and all
     licenses, permits or approvals required will be completed.
     For example, FDA Premarket Approval, UL or equivalent, CSA,
     etc.

1.3  Upon completion of the design phase, any changes,
     modifications or corrections made to the product or existing
     documentation must adhere to proper document change
     procedures.  See SOP for Engineering Change/Document Change
     Control Procedures.

2.0  Design Transfer and Documentation

2.1  One of the first steps in the transfer of a design into
     production is to inform the quality assurance manager about
     the new or modified product.  The quality assurance manager
     and the project coordinator will designate appropriate
     persons to be responsible for directing, monitoring and
     reporting all activities for orderly transfer of the product
     into production and through post-marketing activities with
     nothing left to chance.

     Preproduction quality planning by this team must include
     consideration of all significant aspects of the product, the
     manufacture of it, and its ultimate use.  Reviews should be
     performed to make certain that the following two goals are
     fully met.

          -    The desired level of intrinsic quality is in or is
          being designed into the product and/or processes before
          the start of production.

          -    The designs are appropriately reflected by the
          device master record documentation as verified by ample
          evidence that the product specifications (the company
          labeling claims) are met.

2.2  Many of the documents in the device master record will have
     been already be drafted upon completion of the design phase
     of the product (See details of device master records and
     their control in SOP Device Master Records).  Most if not
     all of the documents for device master record need to be
     completed prior to pilot production begins on the new or
     modified product.  These documents may be changed later due
     to changes in requirements, corrections and results from
     process validation, pilot production, etc.
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2.3  If a product design is not adequately translated into
     correct specifications as needed to procure components and
     manufacture finished devices, the resulting product may be
     unsafe, ineffective and/or unreliable.  Therefore, a
     complete and adequate device master record, including all
     labeling and data forms, must be drafted and approved before
     full-scale production and before commercial distribution of
     the product.

     A device master record document plan, which is basically an
     index of table of contents, should be drafted and updated as
     necessary to support product specifications and improve
     communications among involved personnel.  By reviewing the
     document plan, one can see which drawings and procedures are
     completed, in-process, or need to be drafted.

3.0  Production Plan

3.1  Production processes should be planned, developed, validated
     and documented to assure they will routinely achieve the
     intrinsic level of quality designed into the new or modified
     product.

     The adequacy of present facilities and equipment or
     requirements for additional space and/or equipment for
     manufacturing the product should be determined in
     conjunction with the anticipated production rate or volume.
     Included in this determination should be the facilities used
     in, and equipment used for:

          - Environmental Control
          - Assembly or Manufacturing
          - Inspection
          - Testing
          - Labeling Control
          - Component or Product Handling
          - Packaging and Shipping


     Manufacturing, customer, or vendor problems associated with
     previous product designs should be analyzed to eliminate or
     reduce similar problems in new or modified products.

3.2  As discussed above, the product, and as appropriate, the
     packaging must be defined in terms of desired attributes,
     such as physical and performance characteristics.  These
     attributes must then be translated into written product
     specifications, as discussed, and manufacturing
     specifications to assure that the finished product conforms
     to the approved design.
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     Acceptable ranges or limits must be established for each
     attribute.  The validity of the acceptance specifications
     should be verified through testing and challenge of the
     product, packaging and manufacturing processes during their
     development and later during pilot-production.

3.3  The manufacturing processes and equipment should be designed
     and/or selected so that in-process and finished product
     specifications are consistently achieved.  This selection
     should be done with the participation of all appropriate
     groups that are concerned with assuring a quality device
     (e.g., Engineering, Production and Quality Assurance).  The
     next step is to arrange, obtain and install and qualify
     equipment and tooling for the processes.

     After process equipment is designed or selected, it should
     be reviewed, calibrated, evaluated and tested to verify that
     it is capable of operating satisfactorily within the
     operating limits required by process specifications.

     Information obtained from qualification studies of process
     equipment and ancillary systems should be documented and
     used to:

          -    establish written equipment calibration and
          maintenance procedures.

          -    establish manufacturing procedures for the
          monitoring, operation and control of the equipment
          including the minimum number of operators.

          -    establish any needed environmental controls and
          procedures.

          -    assure that the work area has sufficient space to
          perform the processing and associated activities.

3.4  The production planning process should also include
     development of programs to train personnel as required to
     produce the new or modified product.  One very valuable
     training technique is to require manufacturing personnel
     assist engineering in assembling and evaluating prototypes.
     This technique:

          -    achieves advance training for manufacturing
          personnel.

          -    reduces production problems by improving the
          producibility of the product based on the expertise and
          input of the manufacturing personnel.

          -    improves communications and technology transfer
          between the various departments.
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3.5  The evaluation of a new product and its associated
     manufacturing processes should usually include pilot
     production of a few units.  Pilot production is recommended
     as it helps debug the product design and overall production
     program.  Thus, pilot production should be planned so that
     manufacturing activities are monitored, problems are
     discovered and resolved and documentation is updated.

3.6  As part of the quality assurance program for new or modified
     products, final prototypes or pilot-production models must
     be evaluated by the product development group to determine
     that the product conforms to specifications.  A Finished
     Product Release form (Exhibit 3) should be completed and all
     evaluation data and associated records should be reviewed by
     the design review group.

     Any discrepancies in the finished products versus the
     specification and other elements of the device master record
     must be resolved before the product is released for full-
     scale production.  If pilot models are to be commercially
     distributed, the pilot units must meet master record
     requirements and be approved for release.  As an alternate,
     pilot models may be used internally for technical writers or
     in training programs for production and service personnel or
     as marketing displays.