SAE AS 6414A:2017 – Manufacturing Processing Requirements for Molded Elastomer Components Used in Aerospace Applications.
2. If the compounder is not currently registered to ISO 9001 then the manufacturer shall annually approve the compounder by on• site audit.
The compounder’s quality record shall be current and on-file at the manufacturers facility.
3.1.2 A captive compounder shall be qualified as part of the manufacturers AS9100 registration.
3.2 Control of Compounding Ingredients
3.2.1 The compounder shall have a process for receiving and storing compound ingredients until they are needed. All compounding ingredients shall be stored according to the chemical manufacturer’s recommendations and In a work environment per AS9100 to ensure conformity of ingredient requirements.
3.2.2 The compounder shall have a process 10 identify and maintain initial shelf life of compounding ingredients not to exceed the chemical manufacturer’s expiration date.
3.2.3 If an extension of shelf life is required, the compounder shall have a process to verify the extension of all compounding ingredients’ shelf lives. Extended shelf life of any ingredient shall be documented along with the verification data per the manufacturers standard of work.
3.3 Process for Combination of Compounding Ingredients
3.3.1 Formulation Control The compounder shall have a controlled recipe that specifies formulation or the compounder shall use the manufacturer’s supplied formulation. The compounder shall not change any ingredient in the formulation without the prior wrilten approval of the manufacturer who may require verification testing up to and including full qualification testing prior to approving a change. If required by the customer contract or purchase order, the manufacturer shall notify the customer of any formulation change.
3.3.2 Mixing The Compounder shall have a documented procedure for the mixing of the compound and shall have evidence that will include but are not limited to:
The Compounder shall have evidence that the procedure has been followed and verified.
The supplier shal identify those changes which require customer acceptance in accordance with contractual requirements prior to making any change
Changes affecting processes, production equipment, tools and programs shall be documented. Documented procedures shall be available to control their implementation.
The results of changes to production processes shall be assessed to confirm that the desired effect has been achieved without adverse effects to product quality.
3.3.3 Testing at the Compounder The compounder shall perform the appropriate tests required by the manufacturer to confirm that the manufacturer’s requirements for each batch have been met and the results shall be documented and available upon request by the manufacturer. If required by the manufacturer, the compounder shall also prepare a duplicate series of test samples for the manufacturer.
3.3.4 Rework at the Compounder MaterIal that faifs to meet the initial manufacturers P0 requirements, may be reworked up to a maximum of three (3) times and retested after each rework prior to Informing the manufacturer. If the reworked compound meets the initial manufacturer’s P0 requirements for acceptance, then the compound can be shipped with provisional approval pending the manufacturer’s review of the compounders data and the manufacturer’s acceptance testing.
3.3.5 Rejected Compound
33.5. I Compound batches that fail the compounder’s quality control requirements or those rejected by the manufacturer shall be clearly identified and excluded from use in products requiring AMS7XXX series specifications, user specifications, or print on a Purchase Order (P0) that calls out this document for aerospace applications.
4.1 General Requirements
4.1.1 The manufacturer shall have a procedure for identification of the status of all batches of compounded material at the production facility (for example, 1-)old for Testing. Approved’. ‘Rejected).
4.1.2 The manufacturer shall have a documented acceptance procedure for approving compound before it is released to production.
4.1.3 Storage and Identification All compounded material shall bear a unique identification batch number for traceability of test results. Manufacturer shall have a procedure for storage of compounded material and mamtaining shelf life control. For AMS7XXX series specifications, user specifications, or print on a Purchase Order (P0) that calls out this document for aerospace applications, prior louse, the manufacturer shall run batch acceptance tests on stored compound if it has exceeded its initial shelf life per the applicable specification. If all the values are within the acceptance testing requirements per the applicable specification, then the material is still approved for use. This process shall not exceed a maximum ot 1 year br all specifications and if beyond 1 year the manufacturer shall have a process to run a batch/acceptance test prior to extending the shelf life for an additional shell life cycle per the applicable specification. If testing indicates that the compound is outside the allowable limits. it cannot be reworked and must be clearly identified and segregated and excluded from use in products requiring AMS7XXX series specifications, user specifications, or print on a Purchase Order (P0) that calls out this document for aerospace applications.