Under part 21 §21.303(h), the applicant must establish and maintain an FIS.   The description of the FIS may be in any form acceptable to the FAA, however, for durability and easy reference, it is suggested that this description be in the form of a manual, indexed as necessary, describing the methods, procedures, inspections, and tests which the applicant and his suppliers intend to use to meet the requirements of part 21 §21.303(h)(1)-(9), provisions for reporting under part 21 §21.3 and provisions for identifying the product in accordance with part 45 §45.15.  The description may result in a lengthy document, or it might contain only a few pages, dependent upon the size of the applicant's facilities and the number and complexity of parts being manufactured.   In describing the FIS, references to other documents or data maintained by the applicant may be utilized in lieu of a detailed description of a particular procedure, provided that a brief description is included in the manual and the referenced documents provide a complete description of the system.   All referenced documents must be submitted for approval as part of the FIS description.   If procedures or data are kept at or controlled by the original design/production approval holder under a contractual arrangement with the applicant, the applicant must demonstrate contractual provisions or provide other appropriate written assurance of the procedure for communicating design and manufacturing changes to the applicant.   The applicant should also demonstrate that termination of the contractual relationship would not affect the applicant's ability to maintain compliance with the established FIS.   For record purposes, the description should also include a facsimile of the applicant's symbol, trademark or prefix/suffix.   The following paragraphs, headed by the section of part 21 to which they apply, provide an example of the material usually found in an acceptable description.   [NOTE: items in RED are applicable parts of 14 CFR §21.303 referenced in the order.   They are not actually part of FAA Order 8110.42, Appendix 8.   Ed.]

1. Section 21.303(h)(1)
   [Incoming materials used in the finished part must be as specified in the design data.]
   

   The portion of the FIS established to comply with this section would usually include the procedures that ensure conformity to approved design data of all supplier-furnished materials and services.   Generally, this part of the FIS description would describe the manner by which the applicant ensures that:
   

   1. All incoming materials conform to approved design data prior to their acceptance and release to production.
   2. Provisions are made for the evaluation and surveillance of suppliers by the applicant when it relies to any degree upon a supplier's inspection system.   The surveillance of suppliers of proprietary parts must enable the applicant to determine that incoming materials conform and that supplier services are performed correctly.
   3. Suppliers, including suppliers of proprietary parts upon whom an applicant relies for controlling conformity and quality, should be formally advised that their inspection system and materials being supplied are subject to inspection by the FAA.   When a supplier from a country other than the U.S. is involved, the FAA will determine whether the performance of any FAA duties at the supplier's facilities would result in an undue burden being placed on the FAA.   If such FAA duties would be required, a means acceptable to the FAA of relieving any undue burden must be found, or it will be necessary for the applicant to perform all required functions in the U.S.
   4. Positive control is exercised over the design configuration and condition of all parts obtained from suppliers.   The fact that the supplier does not hold a production approval for the part re-emphasizes the PMA holder's responsibilities for the design configuration of the part.
   5. All material review actions and design changes made by suppliers, including suppliers of proprietary over which the applicant does not exercise direct design control, are evaluated by the applicant and approved as applicable in accordance with part 21§21.303 (d) and part 21, Subpart D.
   6. Records are maintained of all inspections and tests performed by or for the applicant in controlling the conformity of all supplier-furnished materials.
   7. All incoming materials and services, including related inspection and test records are identified with appropriate acceptance, rejection, or rework stamps as applicable.



2. Part 21 §21.303(h)(2)
   [Incoming materials must be properly identified if their physical and chemical properties cannot otherwise be readily and accurately determined.]
   

   The FIS description will include the system the applicant will utilize, with respect to compliance with this section, to ensure that the physical and chemical properties of incoming material are as specified in the approved design data.



3. Part 21 §21.303(h)(3)
   [Materials subject to damage and deterioration must be suitably stored and adequately protected.]
   

   An acceptable description of the storage and issuance system established by the applicant would include the procedures that ensure:
   

   1. Identification, segregation, and protection of materials in storage.
   2. Periodic re-inspection and disposition of materials subject to deterioration from prolonged storage.
   3. Protection from damage of materials, and of components being delivered to fabrication or shipping areas, and while stored in fabrication areas prior to use.
   4. Incorporation of all applicable design changes prior to release of stored components for installation in the part.
   5. That only those materials and components which are identified as having passed receipt inspection criteria are received into, and issued from, storage.



4. Part 21 §21.303(h)(4)
   [Processes affecting the quality and safety of the finished product must be accomplished in accordance with acceptable specifications.]
   

   The integrity of processes and services utilized in the manufacture of parts is dependent upon the skill with which the work is performed, the capabilities of the equipment used, and close control of critical factors such as temperatures, solutions, curing time, special tools, etc.   A system to control processes and services, such as welding, brazing, heat treatment, plating, and radiographic, ultrasonic, or magnetic particle inspection, etc., requires that each process be performed by trained and qualified personnel and in accordance with approved specifications containing definitive standards of quality, and that periodic inspection of gauges, solutions, or any critical equipment is controlled and documented.   The description with respect to this section in the FIS manual should explain the procedure by which the applicant will qualify personnel, and control processes performed at the approved facilities, as well as by suppliers, and should generally include a listing of manufacturing processes which are relied upon to assure quality, conformity, and safety of the completed parts.



5. Part 21 §21.303(h)(5)
   [Parts in process must be inspected for conformity with the design data at points in production where accurate determination can be made.   Statistical quality control procedures may be employed where it is shown that a satisfactory level of quality will be maintained for the particular part involved.]
   Compliance with this section requires that procedures be established to control all phases of inspection of the part.   The FIS description should, therefore, provide descriptions of all procedures established by the applicant to ensure that all inspections and tests will be conducted in the proper sequence, when components and processes are in an inspectable condition-"for example, prior to painting or closures."   This is achieved through use of inspection instructions, shop travelers, checklists, or similar media.   Following are examples of inspection functions that would be described to the extent applicable to the complexity of the parts or size of the manufacturer's facilities:
   
   1. Planning Procedures. Such procedures would ensure that each component used in the part is adequately inspected for conformity with the approved design. This function of the planning system would be facilitated if it provided for:
      
      1. Classifying design characteristics and related manufacturing defects to determine their critical nature so that the most effective fabrication inspection methods and process controls will be used with respect to critical and major characteristics and detecting defects, (reference part 21 §21.93; MIL-STD-105, Sampling Procedures and Tables for Inspection by Attributes; and MIL-STD-414, Sampling Procedures and Tables for Inspection by Variables for Percent Defective).
         
      2. Selection of appropriate inspection methods and plans for each classification to ensure that all characteristics affecting safety will be inspected and re-inspected, as appropriate, to ensure conformity to approved design data and to eliminate discrepancies from in-process and completed parts.
   2. Inspection Status. This system would ensure that appropriate stamps or marks are placed on components or other means are used to indicate their inspection status. It would be helpful if this portion of the description also contains copies of all inspection forms, checklists, and imprints of the various inspection and process stamps and their meanings. Procedures should call for suitable acceptance, rework, or rejection stamps to be used, particularly on life-limited, critical or non-conforming parts, as follows:
      
      1. Materials and components which have been subjected to a process such as heat treatment, welding, bonding, etc., or testing and inspection which may include hardness tests, laboratory analysis, magnetic particle inspection, or similar functions.
      2. Materials and components which have been inspected at the specified point in production and are found in conformity with the approved design.
      3. Materials and components that are rejected as being unusable or scrap so as to preclude their installation.
   3. Tool and Gauge Control.   This system should provide control over periodic inspection and calibration of inspection tools, gauges, testing equipment, production jigs, fixtures, templates, etc., which are depended upon as media for inspection product acceptance.   The description of the means utilized for tool and gauge control should include a schedule of periodic or usage inspection and calibration intervals to ensure that tools, gauges, etc. are inspected, adjusted, repaired, and/or replaced prior to their becoming inaccurate.   The inspection system description should also describe the procedures for implementing the tool and gauge control schedules.   Such procedures would basically ensure that each piece of equipment is:
      
      1. Checked prior to first usage and at the proper periodic interval and marked to indicate that it is under calibration control and the date that the next inspection is due; and
      2. Removed from inspection and shop areas or conspicuously identified to prohibit usage after expiration of the inspection due date.
   4. Final Inspection.   This function of the inspection system would ensure that each completed part is subjected to a final inspection to determine conformity with approved design data; compliance with applicable FAA airworthiness directives and, whether the part is safe for installation on type certificated products.   Such a system would usually incorporate procedures to ensure that:
      
      1. Each part is inspected for completeness, adjustments, safety, calibration, markings, placards, etc., as applicable to the complexity of the part.
      2. If applicable, each completed part or appropriate sample is subjected to a functional test to ensure that the operating characteristics meet the approved design provisions.


6. Part 21 §21.303(h)(6)
   [Current design drawings must be readily available to manufacturing and inspection personnel, and used when necessary.]
   

   The description of the system established for compliance with this rule includes:

   1. The procedures utilized to ensure that current design drawings are readily available to manufacturing and inspection personnel, and use when necessary, and
   2. The procedures utilized to ensure that drawings and data which are obsolete, or affected by superseding data, or FAA airworthiness directives are promptly removed from production and inspection areas or otherwise controlled to prevent their improper use.



7. Part 21 §21.303(h)(7)
   [Major changes to the basic design must be adequately controlled and approved before being incorporated in the finished part.]
   

   The description of the drawing change controls required by this regulation should include procedures to ensure that, prior to final acceptance of articles and completed parts, all changes required to be FAA-approved have been approved and are incorporated in the applicable drawings or covered by change notices attached to such drawings.   The inspection system manual would, therefore, include a section describing or referring to the drawing change control system.   If the drawing change control system refers to or relies upon the original design approval holder's system through a contractual relationship, the applicant should demonstrate contractual provisions or provide other appropriate written assurance sufficient to ensure that all changes will be incorporated into the finished parts) manufactured by the applicant.   In such a case, the applicant should also indicate how it would establish a new system to maintain the FIS should the contractual relationship with the original design/production approval holder be changed or terminated.



8. Part 21 §21.303(h)(8)
   [Rejected materials and components must be segregated and identified in such a manner as to preclude their use in the finished part.]
   

   The description of the procedures established for compliance with this regulation includes provisions for engineering evaluation of rejected materials and articles to determine whether they can be reworked, repaired, or accepted "as is" without affecting the airworthiness of the part.   Approval for the PMA applicant to utilize this provision shall consider the ability of the applicant to substantiate the effects of non-conformance or repair to the safe performance of the part and its parent system(s).   If the procedures proposed by the applicant to demonstrate compliance with the FAR rely upon a contractual relationship with the original design approval holder, the applicant must demonstrate contractual provisions or provide other appropriate written assurance indicating how compliance by the applicant with applicable requirements will be ensured.   In such a case, the applicant should also indicate whether it would need to establish a new system to maintain the FIS should this aspect of the contractual relationship with the original design/production approval holder be changed or terminated.



9. Part 21 §21.303(h)(9)
   [Inspection records must be maintained, identified with the completed part, where practicable, and retained in the manufacturer's file for a period of at least 2 years after the part has been completed.]
   

   Compliance with this section requires that procedures be established for maintaining inspection records.   This includes all inspections accomplished on the parts from raw materials to finished parts.   There should be a procedure established for identifying inspection records where practicable with parts, such as serial numbers, dates, codes, etc.   The applicant must file and retain the inspection records for a period of at least 2 years after the part has been completed.