ISO9001：2015一整套程序文件英文版Procedure: [Change Mgmt Doc Title]1.0SUMMARY1.1.The purpose of this procedure is to define the methods for managing changes to processes andother aspects of the management system in a controlled manner.1.2.Where this document discusses changes to processes, this shall be understood to mean the top-level processes identified in the [Quality Manual Doc Title].1.3.The [who?] is responsible for implementation and management of this procedure.2.0REVISION AND APPROVALRev.Date Nature of Changes Approved By[RevNumber][Date of Issue]Original issue.[Procedure Approver Name]3.0CHANGES TO PROCESSES3.1.Management system processes will undergo changes, typically when:3.1.1.Improvement opportunities have been identified, typically to improve processeffectiveness3.1.2.Nonconformities within a process are identified and require corrective action3.1.3.Conditions in the industry or company change, requiring a process to be updated3.1.4.New processes are added which impact on existing processes, requiring changes3.1.5.Customer requirements result in a need to change processes3.1.6.Any other reason determined by management3.2.In such cases, the process must be changed in a controlled manner to ensure proper authorizationand implementation of the changes.3.3.At a minimum, process changes shall include the steps herein:3.3.1.The request for a process change shall be documented, typically in a [CAR Form Name]per the procedure [Corrective Preventive Action Proc. Title]. The justification for thechange shall be recorded.3.3.2.The change shall be reviewed by appropriate management, including the senior mostmanager responsible for the process. Changes must be approved prior toimplementation.3.3.3.The appropriate [Process Definition Doc Title] will be updated to reflect the change.This document will undergo review and approval per the procedure [Control ofPage 1 of 2Documents Proc. Title]. The revision indicator of the [Process Definition Doc Title] willbe incremented, and the nature of the change recorded. [ Delete last sentence if youare not using Process Definition documents.]3.3.4.The follow-up verification step of the [CAR Form Name] process shall seek to ensurethe change has had the intended effect, and/or has improved the process. If not, thechange may be rolled back or a new change made to correct any new issues that ariseas a result of the change.4.0CHANGES TO DOCUMENTATION4.1.Management system documents undergo changes when there is a need to revise them.4.2.Changes to documentation are done in accordance with the procedure [Control of DocumentsProc. Title].5.0CHANGES TO ORDERS OR CONTRACTS5.1.Changes to active orders or contracts may occur when the customer changes the requirementsafter the work has begun, or may be initiated by [Short Client Name] when unforeseencircumstances are encountered.5.2.Changes to orders or contracts are done in accordance with the procedure [Quoting and OrdersDoc Title].Page 2 of 2Procedure: [Identification & Traceability Proc. Title]1.SUMMARY1.1.This procedure defines the methods used to identify and (where applicable) provide uniquetraceability for [Short Client Name] products. This procedure includes methods:1.1.1.To define the methods for identifying products (what they are)1.1.2.To define the methods for identifying products as to their current inspection or teststatus1.1.3.To define the methods for segregating and discriminating between product andtooling when their appearance is similar1.1.4.To define the methods for providing traceability, including unique serialization, orproduct as applicable1.2.The [who?] is responsible for implementation and management of this procedure.2.REVISION AND APPROVALRev.Date Nature of Changes Approved By[Rev Number][Date ofIssue]Original issue.[ProcedureApproverName]3.APPLICATION3.1.This procedure applies to all departments which use, handle, transport, store, inspect ormanufacture product, raw materials and tooling, at all [Short Client Name] facilities.3.2.This procedure not only applies to typical product, but also deliverables from services, such asreports, schedules, etc.3.3.Non-critical materials or supplies, which are not incorporated into final product or which serveonly to support facilities or operations, are not subject to this procedure.4.DEFINITIONS4.1.Product4.1.1.“Product” includes any of the following:∙Any part, assembly or item ordered by the customer∙Deliverable reports or documents∙Product may refer to finished product, or work in process (WIP)Page 1 of 44.2.Raw Materials4.2.1.“Raw materials” include any of the following:∙Any materials or items (metals, plastics, components, pre-built assemblies, small parts) which become part of the finished product’s physical construction; some of these itemsmay sometimes be referred to as “consumables”.∙Coatings, paint, plating, adhesives, chemicals or materials which will be incorporated into (or onto) the final product.4.3.Tooling4.3.1. “Tooling” can include any of the following:∙Devices used by manufacturing for setup or production, including fixtures and jigs.∙Devices used by inspection for determining acceptance of product, including test fixtures.∙Shop aids, which are simple devices (blocks, spacers, shapes) used to assist in production or development, but which are not precision tools and which can be usedfor a variety of applications.4.3.2.Tooling does not include:∙Cutting tools, drill bits, etc.∙Hand tools∙Machining equipment5.PRODUCT5.1.There are many ways to identify product; this procedure presents the most typical, acceptablemethods. Additional product identification methods may be called out in the design or production documentation.5.2.Identification typically includes the part number, revision, Work Order # and unique serialnumber (if applicable).5.3.Identification is done through any of the following methods:5.3.1.Part marking, by way of ink marking, etching or some other method.5.3.2.Bag-and-tag methods, especially for small parts.5.3.3.Placement of parts on shelves or in containers that are properly marked, withsignage or other methods.5.3.4.Placement of parts near associated paperwork, for the purpose of identification andtraceability, may be used if the paperwork can clearly be identified as relating to theparts in question, typically by way of the inclusion of a drawing which can becompared to the product.5.3.5.Segregating entire areas of the production floor with belt stanchions and attachedsignage, indicating what type of items are allowed, or disallowed, within the enclosedarea.Page 2 of 45.4.Where unique serialization is required for traceability, the parts shall be identified with a serialnumber in accordance with customer requirements, or in a manner developed to ensure that no two parts are given the same number. Serial number logs may be used to control this; workorders shall reference the serial numbers under which the unique parts were built.5.5.All product may be assumed to be inspected and/or tested and found to be acceptable for use ifidentified in accordance with the rules above, unless it is marked as nonconforming product. For the methods of identifying nonconforming product, see procedure [Control of NCP Proc. Title].6.RAW MATERIALS6.1.Raw materials requiring traceability back to heat lot numbers, manufacturer lot or batchnumbers, certificates of conformity or analysis, etc., must be marked in a way that provides this traceability. This is typically done by marking the raw materials with the [Short Client Name]purchase order number under which the items were purchased, and the supplier’s lot number.6.2.When raw materials are used, any remaining material that will be returned to stock and used inthe future must be re-identified before re-entry into inventory.6.3.Raw materials which are determined to require identification and traceability, but which lacksuch identification, may not be used for flight hardware. These may be used for tooling stock or other non-product purposes.6.4.All raw materials may be assumed to be inspected and/or tested and found to be acceptable foruse if identified in accordance with the rules above, unless it is marked as nonconforming. For the methods of identifying nonconforming raw materials, see procedure [Control of NCP Proc.Title].7.PRODUCTION TOOLING7.1.Tooling used for production (fixtures, molds, jigs, setup devices, product supports or stands,etc.) shall be designed and built according to engineering data, and then validated to ensure the tool performs the intended function without risk or harm to product. Validation of tooling istypically done by using the tooling and inspecting the resulting parts to ensure the tooling results in parts that meet dimensional or other requirements.7.2.Once validated and approved for use, the tool will be marked with a tooling ID number, which istypically the part number for which the tool is to be used.7.3.Tools that produce production hardware or are used to accept hardware must undergoinspection before release. [QC or QA Preferred Term] must stamp or mark the tool as accepted before it can be used.7.4.Shop aids for setup of production operations, supporting a part temporarily, or other simple ortemporary use, may not require identification with a unique identifier. Instead, these must beidentified as tooling by either marking the item itself as “TOOLING” (or similar language) orplacement in an area, shelf, cabinet or other container that is properly marked as “TOOLING” or “SHOP AIDS”(or similar language). The marking must allow tooling to clearly be distinguishedfrom raw material or product (whether flight or development).Page 3 of 47.5.Tooling used for lifting shall be proof load tested and include an upper load lift limit, as requiredby regulations.7.6.Tooling found to be nonconforming shall be tagged to prevent use until fixed, repaired ordeemed acceptable. Segregation of nonfonconforming tooling from the production area should be performed when possible.7.7.When approved tooling undergoes modification, the identification must be updated to reflect thechange; this is typically done by editing or re-marking the item with the latest revision of theengineering part number.8.SERVICE DELIVERABLES (← delete if not applicable)8.1.Service deliverables, such as reports and schedules, shall be identified with a title and, ifapplicable, reference to the project or contract under which they are developed.8.2.Customer contracts may indicate additional methods for identification of service deliverables.8.3.In all cases, the deliverable will be identified in a way that makes it clearly understood forwhich contract or project the deliverable is subject to.8.4.As required, service deliverables may be subject to date and revision control, to distinguishearlier versions or submittals.9.STAMP CONTROL (← delete this section if QC stamps are not used)9.1.Quality stamps or employee initials are used to indicate product acceptance or for other quality-related notations. Individual authorities for signing off for inspection, testing and operations are defined on the Stamp & Signature Control Log; this log is maintained to identify the owner of each stamp.9.2.The [who?] shall maintain the Stamp and Signature Control Log.9.3.Stamps are numbered, and taken out of service for six months after an employee leaves thecompany; after the six-month period, the stamp may be reissued to a different employee.9.4.No employee may use any stamp except that which was issued to them.Page 4 of 4Procedure: [Control of NCP Proc. Title]1.0SUMMARY1.1.This procedure defines the requirements for identifying, processing and dispositioningnonconforming product (“NCP”).1.2.While nonconforming product is typically found during an inspection or test, it can be discoveredat any time, by any person or organization, including the customer, regulatory authorities, etc.1.3.The [who?] is responsible for implementation and management of this procedure.2.0REVISION AND APPROVALRev.Date Nature of Changes Approved By[RevNumber][Date of Issue]Original issue.[Procedure Approver Name]3.0DEFINITIONS SPECIFIC TO THIS PROCEDURE3.1.Nonconforming product: This is any product, at any point along its life cycle, which is found tonot conform to requirements. These requirements may be customer requirements, designrequirements, statutory/regulatory requirements, or any other requirement deemed by [ShortClient Name]. “Nonconforming Product” is referred to herein as “NCP”.3.2.Rework: Parts may be “reworked” when additional machining or processing is conducted withoutaffecting the design of the part. Typically this means simply doing more of the already-approvedprocesses or activities listed on the traveler (additional machining, etc.)3.3.Repair: Any work done on NCP which affects the original design is considered “repair” and issubject to the special controls defined below. Such work includes but is not limited to the addingwelds to correct a problem, adding or removing material beyond design specifications, addingplating or metal finishing not originally included in the design specs, or adding any other materials(epoxy, patches, etc.) not provided for in the original design.[This procedure is divided into two sections, one for companies which utilize an Material Review Board (MRB), and one for companies that do not. Delete whichever section does not apply, and modify theremaining section accordingly.]4.0CONTROLLING NCP [ use if MRB is utilized.]4.1.Discovery and Reporting of NCP4.1.1.When NCP is discovered, the operator must report this immediately to the [who?]4.1.2.The [who?] will review the problem to confirm the nonconformity. If the nonconformityis confirmed, the product will be identified clearly to distinguish it from acceptablePage 1 of 4product, or product awaiting inspection or test. [enter method here: tagging,segregating, MRB cage, etc.?].4.1.3.The [who?] will determine if the nature of the nonconformity necessitates full MRBreview. A full MRB review is required if the [who?] thinks that any of the followingdispositions may be required:∙Accept as is, with customer waiver∙Accept as is, with regulatory approval∙Repair – see special rules below below.4.1.4.Typically, a full MRB is not required if the [who?] determines the part only needsrework, or if it can be scrapped without impacting the quantity required for an order,if applicable.4.1.5.If full MRB is not deemed necessary, the [who?] may direct a disposition of rework orscrap.4.1.6.The operator may scrap nonconforming parts that are not serialized during production,provided that the operator makes a note of this action on the traveler.4.2.Disposition Authority4.2.1.Disposition authority is granted to the following personnel:∙Title∙Title∙Title4.2.2.The selection of these staff members has been made by top management, and is basedon their role in the company, previous experience, and knowledge of [Short ClientName]’s processes and products.4.3.MRB Review4.3.1.When a part is submitted for Material Review Board (MRB) review, this must beindicated on the Nonconforming Part Disposition form, and the parts staged in an MRBquarantine area.4.3.2.The nature of the nonconformity, along with all necessary product information,including serial numbers, shall be recorded on the Nonconforming Part Dispositionform. The description of must be a detailed explanation as to why a part or parts arebeing rejected; the form must include nominal/tolerance and actual measurements.4.3.3.The MRB consists of [list members by title here].4.3.4.The MRB shall research the issue and determine a possible disposition:∙Accept as is∙Repair (see special rules for repair below)Page 2 of 4∙Rework∙Scrap (see rules for processing scrap below)∙Return to Vendor4.3.5.If “accept as is” will require the acceptance of the part which deviates from acustomer’s design, the customer approval must be obtained and documented on theNonconforming Disposition Form. In addition, in some case regulatory authorityapproval may also be required to be obtained and recorded.4.3.6.The processing of NCP must take into consideration any actions necessary to containthe effect of the nonconformity on other processes or products.5.0CONTROLLING NCP [ use if MRB is NOT utilized.]5.1.Discovery and Reporting of NCP5.1.1.When NCP is discovered, the operator must report this immediately to the [who?][NOTE: in some companies, operators are allowed to scrap parts without any otherapproval, provided they note it on the traveler. If so, add that language here.]5.1.2.The [who?] shall confirm if a nonconformity exists, and if so document it on the [whatform?]5.1.3.The NCP shall then be identified clearly to distinguish it from acceptable product, orproduct awaiting inspection or test. [enter method here: tagging, segregating, MRBcage, etc.?].5.1.4.The NCP shall then be dispositioned. Disposition authority is granted to the followingpersonnel:∙Title∙Title∙Title5.1.5.The selection of these staff members has been made by top management, and is basedon their role in the company, previous experience, and knowledge of [Short ClientName]’s processes and products.5.1.6.Possible dispositions are:∙Accept as is∙Repair (see special rules for repair below)∙Rework∙Scrap∙Return to VendorPage 3 of 45.1.7.All repair or reworked product must be re-inspected, with the results recorded on[what form?]5.1.8.If “accept as is” will require the acceptance of the part which deviates from acustomer’s design, the customer’s approval must be obtained and documented on the[what form?] form. In addition, when applicable, regulatory authority approval(s) mayalso be required to be obtained and recorded.5.1.9.The disposition, dispositioning authority and any subsequent work and re-inspectionare to be recorded on the [what form?]5.1.10.The processing of NCP must take into consideration any actions necessary to containthe effect of the nonconformity on other processes or products.6.0SPECIAL RULES FOR REPAIRS ( delete this section if not applicable)6.1.“Repair” is defined in section 1 above.6.2.Any repair affecting a customer designed part must be approved by the customer in advance.6.3.Repairs without customer approval are disallowed in all circumstances!6.4.All approvals must be documented and the records maintained with the part records.7.0NONCONFORMANCE DATA ANALYSIS & TRENDING7.1.The [who?] will present product quality trend data regularly to top management as part ofperiodic Management Review Meetings.Procedure: [Purchasing Proc. Title]1.0SUMMARY1.1.This procedure defines the requirements for evaluation and selection of critical suppliers,purchasing critical materials and services, and monitoring supplier performance.1.2.The receipt and receiving inspection of incoming purchased items is defined in the procedure[Receiving Proc. Title].1.3.“Critical materials or services” are those materials or services which are incorporated into finalproduct, or which have a direct impact on the company’s product or quality system, or which areotherwise deemed as critical by management.1.4.Office supplies, administrative consumables, furniture, etc. are not critical materials, andtherefore not subject to this procedure.1.5.[Short Client Name] understands it is responsible for the conformity of all products purchasedfrom suppliers, including product from sources defined by the customer.1.6.The [who?] is responsible for implementation and management of this procedure.2.0REVISION AND APPROVALRev.Date Nature of Changes Approved By[RevNumber][Date of Issue]Original issue.[Procedure Approver Name]3.0SUPPLIER EVALUATION, SELECTION AND CONTROL3.1.The [who?] evaluates new suppliers. This person/these individuals has/have both theresponsibility and authority to approve and disapprove suppliers.3.2.New suppliers are evaluated in accordance with the following criteria:•Modify this list as needed•Pricing•Availability•Reputation / references•Location•Shipping terms and capabilities•Quality system certification status (ISO 9001 certification preferred)•Quality of samples received (incl. testing results)。
