SUPPLIER QUALITY SYSTEM REQUIREMENTS
GPIS Form PR 7-03B Rev. E 12/29/15
941.216.3500
2236 72nd Avenue East
Sarasota, FL, 34243
Certified by NSF
Suppliers providing products and services to General Pneumatics Inflation Systems, LLC (referred to as GPIS) agree to the implementation and maintenance of the following Quality System requirements.
Planning of Production: clauses
The supplier shall plan and develop the processes needed for production. Planning of production shall be consistent with the requirements of the other processes of the quality system. In planning production, the supplier shall determine the following as appropriate:
quality objectives and requirements of the product the need to establish processes, documents and provide resources specific to the product
required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance
Have Counterfeit Parts Awareness and Prevention practices in place to assure authentic material and parts are provided to GPIS (Use AS6174 as guidance).
records needed to provide evidence that the production processes and resulting product meets requirements
Production and Service Provision:
The supplier shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:
the availability of information that describes the characteristics of the product
the availability of work instructions, as necessary
the use of suitable equipment
the availability and use of monitoring and measuring devices
the implementation of monitoring and measurement
the implementation of release, delivery and post-delivery activities
FIRST ARTICLE INSPECTION REPORTS
First Article Inspection report(s) for source controlled part number items must accompany your first shipment of such part(s) in satisfaction of this Purchase Order. Any FAI performed must comply with the guidelines of AS9102, Aerospace First Article Inspection Requirement. In addition, any FAI report form generated shall not contain open fields. To ensure each field of the FAI has been reviewed, the supplier shall mark all open or unused fields “N/A”.
CoC/CoA:
Certification of Conformance / Compliance (CoC) shall accompany each shipment. A Certificate of Analysis may replace a CoA for raw materials and chemicals that assures conformance to all applicable material specification requirements. The Certificate of Conformance shall provide a statement of conformity (e.g. “I hereby certify the materials / service supplied was produced in accordance with the Purchase Order, applicable drawings and specification.”) and as a minimum include,
Supplier name and address
Signature and title of authorized supplier representative,
Date of Certification,
Supplier Part number Revision Level and description,
Quantity,
Country of origin,
Serial#, batch# or lot numbers (as applicable)
Manufacturing expiration date (as applicable)
CAGE Code (if applicable)
Non-Conformation Notification and Corrective Action:
The supplier must notify GPIS of all nonconforming products that is submitted as part of contract fulfillment, and obtain approval prior to submittal. GPIS will notify supplier in writing upon detection of nonconforming product with product/lot information and a description of the nonconformance. Within five work days of receiving a Non-conformance Notification, the supplier shall provide a statement of corrective action. When a containment action is required, the supplier shall respond within 24 hours. All rejected material resubmitted by supplier to GPIS shall bear adequate identification, including reference to the rejection.
Changes in Product and or Process Definition:
The supplier shall notify GPIS of any changes in product and /or process definition within ten days of the subject changes, and obtain GPIS’s approval if required by contract.
Validation and GPIS approval of special processes:
The supplier shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring and measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results. Note: These processes are frequently referred to as special processes. The supplier shall request and receive approval from GPIS for special processes that are planned to be used on products and services provided to GPIS.
Use of Special Process Sub-tier suppliers:
Unless authorized in writing to the contrary, all special process sub-tier suppliers must be approved for use by GPIS, or their customers, prior to the issuance of contracts by the supplier.
Identification and traceability:
Where appropriate, the supplier shall identify the product by suitable means throughout product realization. The supplier shall identify the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the supplier shall control and record the unique identification of the product.
Preservation of Product:
The supplier shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of the product.
Design and Development:
When design and development activities are contracted, the supplier shall submit a plan for approval to GPIS that controls the design and development activities/stages as follows:
identification of the design and development activities/stages
determination of the review, verification and validation activities for each design and development stage
responsibilities and authorities for the design and development activities
design and development inputs and outputs
records of the results of the above reviews, verification and validation activities
records of design and development changes
Control of Monitoring and Measuring Devices:
The supplier shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. The supplier shall establish processes to ensure that monitoring and measurement are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment shall:
be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded
be adjusted or re-adjusted as necessary
be identified to enable the calibration status to be determined
be safeguarded from adjustments that would invalidate the measurement result
be protected from damage and deterioration during handling, maintenance and handling
In addition, the supplier shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The supplier shall take appropriate action on the equipment and any product affected. Records of the result of calibration and verification shall be maintained.
Records:
The supplier shall establish and/or maintain records that provide objective evidence that applicable above requirements have been complied with. These records shall be:
maintained for a minimum period of seven years from the completion date of the contract
stored in a manner to assure they are legible, readily identifiable and retrievable
available to GPIS personnel (or their designated representatives) within three working days after notification
Flow down of requirements to sub-tier suppliers: