Limited Shelf Material Control Procedure

Transcription

1 Page: 1 of 7 Limited Shelf Material Control Procedure

2 Page: 2 of PURPOSE AND SCOPE 1.1 Purpose The purpose of this procedure is to define the method for Limited Shelf Material Control used at our Company. 1.2 Scope This procedure applied to all customer orders at our Company. 2.0 APPLICABLE DOCUMENTATION The following documents are applicable as the extent specified herein: Industrial/Commercial/Government Documents ISO 9001 Quality Management System - Requirements Internal Document(s) ATS-PGP-3001 ATS-QAP-1005 ATS-QAP-1008 ATS-SOP-1010 Form(s) FORM ATS FORM ATS FORM ATS Receiving Inspection Nonconforming Material System Internal Audits Stockroom Material Control Quarantine QC Passed Released 3.0 RESPONSIBILITIES 3.1 General Production Operations shall be responsible for maintaining this document Receiving Inspection/Stock Room - is responsible for labeling limited shelf materials as defined in this document All Employees - that handle or store materials (records, documentation and electronic data.) shall be responsible for following this procedure.

3 Page: 3 of REQUIREMENTS 4.1 Process Set Up Information The following steps shall be used to set up before starting this process: Step A Receiving Inspection shall have vendor information regarding normal shelf life of perishable materials marked on item, etc. Performance characteristics for the material shall also be available should a request be made to extend the expiration beyond the initial date Materials Obtain the raw material part number and quantity as required: Item No. Part Number Qty Manufacture 1 FORM ATS , A/R ATS Quarantine 2 FORM ATS , QC Passed 3 FORM ATS , Released 4 A/R A/R ATS ATS Fixtures/Tool and Die/Equipment Obtain the Tool(s) and Equipment(s) as required defined in this section: Item No. Model/Part Number Manufacture 1 None 2 3

4 Page: 4 of Process Steps The process steps that shall be used are as follows: Step A When limited shelf material as defined in this document is initially received from a vendor, Receiving Inspection (ATS-PGP-3001) will ensure that item is identified with an expiration date. When the manufacture's label or other written means on the item's packaging (i.e. box, container, etc.) contains the expiration date (i.e. Expires 12/01/15, EXP Dec 2015, Exp. 12/15, etc.), no additional marking is required on the item. The Receiving Inspector shall ensure that the received item(s) from the vendor has at least 80% of the shelf life remaining prior to placing the item(s) into stock to avoid having purchased items shelf life expiring before planned use. When the vendor ships more than one item in a box and the exterior box contains the expiration label, the Receiving Inspector shall ensure each item in the box is also marked or labeled with the expiration date. When a limited shelf life item is received, as specified by figure 1, and is not labeled or marked with an expiration date, the Receiving Inspector shall mark or label the item's packaging with a default 1 year expiration date and record Receiving Inspector's initials as follows: Example (EXP. MM/DD/YY Initials): EXP. 12/01/15 DRC As needed, "Released" and "QC Passed" forms are used to record this information. See Figure 2 - Typical Labels used for control purposes for additional information. The Expiration date will usually be based upon information provided by the vendor. Non- Production perishable material shall be marked/labeled with the item s description/part Number and stored in area clearly identifying the material as Non-Production (no Limited Shelf Life Material label is required). See Figure 1 Production Perishable Materials List Labeling and Label Requirements. Production materials that are defined as not perishable material (i.e. no shelf life requirement) are marked only with the item's Part Number information. Step B Material will be forwarded to production stock only after being identified with valid "Expiration Date" information. Step C Production Operations personnel are responsible for ensuring that perishable material is marked or labeled with "Expiration Date" information using the "Released" and "QC Passed" forms as defined by Figure 1. When an "Expiration Date" is required and not present, the material should be immediately submitted to Receiving Inspection/Quality Assurance for review. Non- Production perishable material shall be marked/labeled with the item s description/part Number and stored in area clearly identifying the material as Non-Production (no Limited Shelf Life Material label is required).

5 Page: 5 of 7 Step D Production Operations will not use shelf life material that is expired, and will remove from use by Quarantine form tagging or returning the expired material to Receiving Inspection as soon as possible. Step E Receiving Inspection will return any material that has reached its expiration date to the vendor unless there is a need to re-qualify the material for further use. NOTE: Receiving Inspection/Quality Assurance may wish to re-certify expired material if sufficient quantities exist to warrant the re-certification effort. Details of this effort follow. Step F Re-certification of the material, or extending its expiration date, may be done by Quality Assurance/Receiving Inspection after an evaluation as to the effectiveness of the material for continued use in production. A typical evaluation includes preparing a work sample using the material to ensure it meets its visual and functional requirements. Items used in the Bio-chemical Lab may not have their shelf life extended. Items used for Service or Value-Added Assembly jobs may have their shelf life extended once the item has been found to be acceptable and will perform its intended function. Step G If the evaluation of expired material indicates that there has been no change to its form, fit, or function, its expiration date may be extended. There is no requirement to retain re-certification samples or visual/test inspection results. Step H If the evaluation of expired material indicates that there has been some change to its form, fit, or function, its expiration date may not be extended, and the material must be scrapped. Material will be scrapped in accordance with ATS-QAP-1005, Nonconforming Material System. 5.0 QUALITY ASSURANCE 5.1 Audits Quality Assurance shall audit this process as scheduled per ATS-QAP-1008, Internal Audits. 5.2 Nonconforming Material All nonconforming material shall be positively identified, segregated, documented, and dispositioned in accordance with ATS-QAP-1005, Nonconforming Material System. Expired for defective shelf life items shall be identified with a Quarantine label and segregated from acceptable items to prevent use.

6 Page: 6 of 7 Item No. Figure 1 Production Perishable Materials List and Label Requirements Part Number (*1) Description (*1) Is Limited Shelf Label Required? Special Expiration Period? 1 All P/Ns Epoxy/Bonding Yes 12 Months, or as specified 2 All P/Ns Oil None Required No Expiration Date 3 All P/Ns Grease None Required No Expiration Date 4 All P/Ns Spray Paints (non- None Required No Expiration Date Production) 5 All P/Ns Primer Paints (non- None Required No Expiration Date Production) 6 All P/Ns 99% Alcohol Isopropyl None Required No Expiration Date 7 All P/Ns Acetone None Required No Expiration Date 8 All P/Ns RTV None Required No Expiration Date 9 All P/Ns Solder Flux None Required No Expiration Date 10 All P/Ns Marking Inks None Required No Expiration Date 11 All P/Ns None Required No Expiration Date 12 All P/Ns Loctite Yes 12 Months, or as specified 13 All P/Ns None Required No Expiration Date 14 All P/Ns Lab Bio-Chemicals & Standards Yes 12 Months, or as specified 15 All P/Ns Yes 12 Months, or as specified 16 All P/Ns Yes 12 Months, or as specified 17 All P/Ns Yes 12 Months, or as specified Notes: (*1) All chemicals require basic material identification labeling (i.e. part number/description), and safety information as required by the manufacture.

7 Page: 7 of 7 Figure 2 - Typical Labels used for control purposes Figure 1 - Released and QC Passed forms use Figure 2 - Released and QC Passed forms use Figure 3 - Released and QC Passed forms use Figure 4 - Quarantine form use