SAE AS 6414A:2017 pdf free download – Manufacturing Processing Requirements for Molded Elastomer Components Used in Aerospace Applications.
3.1.2 A captive compounder shall be qualified as part of the manufacturer’s AS9100 registration.3.2Control 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 workenvironment per AS9100 to ensure conformity of ingredient requirements.
3.2.2 The compounder shall have a process to identify and maintain initial shelf ife of compounding ingredients not to exceed the chemical manufacturer’s expiration date.
3.2.3 lf 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 theverification data per the manufacturer’s standard of work.
3.3 Process for Combination of Compounding Ingredients3.3.1 Formulation Control
3.3.1.1 The compounder shall have a controlled recipe that specifies formulation or the compounder shall use the manufacturer’s supplied formulation.
3.3.1.2 The compounder shall not change any ingredient in the formulation without the prior written approval of the manufacturer who may require verification testing up to and including full qualification testing prior to approving achange.
3.3.1.3 lf required by the customer contract or purchase order,the manufacturer shall notify the customer of any formulation change.
3.3.2Mixing
3.3.2.1 The Compounder shall have a documented procedure for the mixing of the compound and shall have evidence
that weill include but are not limited to:
COMPOUND INGREDIENTS AND PROPORTIONS THEREOF WITHIN ESTABLISHED LIMITSSEQUENCE OF MIXING COMPOUND lINGREDIENTS
TYPE OF MIXING EQUIPMENT (OPEN MILL OR INTERNAL MIXER)
The Compounder shall have evidence that the procedure has been followed and verified.
The supplier shall identify those changes which require customer acceptance in accordance with contractual requirementsprior to making any change.
Changes affecting processes,production equipment, tools and programs shall be documented. Documented proceduresshall be available to control their implementation.
The results of changes to production processes shall be assessed to confirm that the desired effect has been achievedwithout adverse effects to product quality.
3.3.3 Testing at the Compounder
3.3.3.1 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 availableupon request by the manufacturer. If required by the manufacturer, the compounder shall also prepare a duplicateseries of test samples for the manufacturer.
3.3.4.1 Material that fails to meet the initial manufacturer’s PO 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 meetsthe inital manufacturer’s Po requirements for acceptance, then the compound can be shipped with provisionalapproval pending the manufacturer’s review of the compounder’s data and the manufacturer’s acceptance testing.
3.3.5 Rejected Compound
3.3.5.1 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, userspecifications, or print on a Purchase Order (PO) that calls out this document for aerospace applications.
4.MANUFACTURING REQUIREMENTS
4.1General 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,”Hold for Testing””“Approved”, “Rejected”).
4.1.2 The manufacturer shall have a documented acceptance procedure for approving compound before it is released to
production.
4.1.3Storage and ldentification
4.1.3.1 All compounded material shall bear a unique identification batch number for traceability of test results.4.1.3.2 Manufacturer shall have a procedure for storage of compounded material and maintaining shelf life control.4.1.3.2.1 For AMS7XXX series specifications, user specifications, or print on a Purchase Order (PO) that calls out this
document for aerospace applications, prior to use, the manufacturer shall run batch acceptance tests on storedcompound if it has exceeded its initial shelf life per the applicable specification. Iif all the values are within theacceptance testing requirements per the applicable specification, then the material is still approved for use.This process shall not exceed a maximum of 1 year forall specifications and if beyond 1 year the manufacturershall have a process to run a batchlacceptance test prior to extending the shelf life for an additional shelf lifecycle per the applicable specification.
lf testing indicates that the compound is outside the allowable limits, it cannot be reworked and must be clearlyidentified and segregated and excluded from use in products requiring AMS7XXX series specifications, userspecifications, or print on a Purchase Order (PO) that calls out this document for aerospace applications.
