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AS9100D TRANSLATED INTO PLAIN ENGLISH8. OPERATIONSControl your product and service oriented processes and projects.111SHL112SHLUse your plans and criteria to control your organization's processes and projects.DO DN NA113SHLUse your plans and criteria to control outsourced processes and projects.DO DN NA114SHLControl changes in the processes and projects that your organizationneeds in order to meet product and service requirements.DO DN NA115SHLControl planned process and project changes and modifications.DO DN Review uncontrolled process and project modifications.Review all unintended effects and consequences.DO DN NAAlso see section 8.4, below.DO DN NADO DN NAMitigate adverse effects and consequences.DO DN NARetain operational process planning and control documents and records.Retain and maintain documented information that can demonstratethat your processes and projects have been carried out as planned.Control documents and records that monitor how yourorganization’s processes and projects are performing.Retain and maintain documented information that canshow that your products and services meet requirements.Control documents and records that monitorand control product and service conformity.DO DN NADO DN NADO DN NADO DN NADO DN NA8.1.1 ESTABLISH AN OPERATIONAL RISK MANAGEMENT PROCESSPlan your operational risk management process.124SHLDO DN NA125SHL126SHLMake sure that your risk management process is appropriatefor your organization and the products and services it provides.DO DN NA127SHLPlan the assignment of risk management responsibilities.DO DN NA128SHLClarify and define your operational risk assessment criteria.DO DN NA129SHLDevelop a process to manage your operational risks.DO DN NAFigure out how you’re going to determine the likelihood of an occurrence.ORGANIZATION:YOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:JUN 2017PART 8DO DN NAWithin the aviation, space,and defense industry, a risk is anevent or outcome that has twocharacteristics: it is both likely tooccur and likely to have severeconsequences.While risk management isdiscussed in both section 6.1 and8.1, the focus is different. Whilesection 6.1 asks you to considerthe risks and opportunities thatcould influence the performanceof your QMS, section 8.1, on theother hand, asks you to considerthe operational risks related to theprovision of products and services.PLAIN ENGLISH QUALITY MANAGEMENT STANDARDCOPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 81

AS9100D TRANSLATED INTO PLAIN ENGLISH8. OPERATIONS130SHLFigure out how you’re going to evaluate potentially negative consequences.DO DN NA131SHLFigure out how you’re going to make operational risk acceptance decisions.DO DN NA132SHL133SHLFigure out how operational risks will be identified.DO DN NA134SHLFigure out how operational risks will be assessed.DO DN NA135SHLFigure out how operational risks will be communicated.DO DN NA136SHL137SHL138SHLFigure out how you’re going to identify the actionsthat must be taken to mitigate operational risks.DO DN NA139SHLFigure out how you’re going to implement the actionsthat must be taken to mitigate operational risks.DO DN NA140SHLDefine how residual operational risks will be controlled.DO DN NA141SHL142SHLImplement your operational risk management process.DO DN NA143SHLAssign operational risk management responsibilities.DO DN NA144SHLManage your product and service management risks.DO DN NA145SHLIdentify your product and service management risks.DO DN NA146SHLAssess your product and service management risks.DO DN NA147SHL148SHL149SHLEvaluate potentially severe consequences.DO DN NA150SHLMake operational risk acceptance decisions.DO DN NADescribe how operational risks will be managed.DO DN NASpecify how risk management initiatives will be taken.DO DN NAFigure out how to manage the actions that must be taken to mitigate theoperational risks that exceed the limits set by your risk acceptance criteria.Figure out how you’re going to control the acceptable operational risksthat remain after you’ve taken action to mitigate unacceptable risks.Determine the likelihood that events will occur.Determine the likelihood or probability that an undesirableoccurrence or outcome will actually occur in the future.YOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:PART 8This approach to risk asks twofundamental questions: what isthe probability that a potentialevent will occur in the future?And what consequences wouldthis event produce or whatimpact would it have if itactually occurred?DO DN NADO DN NAORGANIZATION:JUN 2017DO DN NAA note in section 8.1.1 of AS9100Dsays that “Within the aviation,space, and defense industry, riskis expressed in terms of thelikelihood of occurrence and theseverity of the consequences”.DO DN NAPLAIN ENGLISH QUALITY MANAGEMENT STANDARDCOPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 82

AS9100D TRANSLATED INTO PLAIN ENGLISH8. OPERATIONSCommunicate your product and service management risks.151SHL152SHL153SHLIdentify the actions that must be taken to mitigate operational risks.DO DN NA154SHLImplement the actions that must be taken to mitigate operational risks.DO DN NA155SHL156SHLControl your operational risk management process.DO DN NA157SHLMake sure that your operational risk managementprocess is appropriate for your organization.DO DN NA158SHLApply the actions that must be taken to mitigate the operationalrisks that exceed the limits set by your risk acceptance criteria.Control the risks that remain after you’ve implementedactions to mitigate unacceptable operational risks.DO DN NADO DN NADO DN NAMake sure that your operational risk management processis appropriate for your organization’s products and services.DO DN NA8.1.2 ESTABLISH A CONFIGURATION MANAGEMENT PROCESSPlan your configuration management process.159SHLDO DN NA160SHL161SHL162SHL163SHL164SHLControl product and service identities and characteristics.DO DN NA165SHLControl product and service traceability to requirements.DO DN NA166SHLControl product and service changes and modifications.DO DN NA167SHLControl product and service documents and records.DO DN NA168SHLMake sure that your configuration management process canbe used to identify and control physical and functional attributesthroughout the product and service lifecycle.Make sure that your configuration management process is appropriatefor your organization and the products and services it provides.Implement your configuration management process.Use your configuration management process to identify andcontrol your organization’s product and service attributes.Make sure that your product and service documents and records areconsistent with the actual attributes of your products and services.YOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:PART 8DO DN NADO DN NADO DN NAORGANIZATION:JUN 2017Blue SHL identifies AS9100 task.DO DN NADO DN NAPLAIN ENGLISH QUALITY MANAGEMENT STANDARDCOPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 83

AS9100D TRANSLATED INTO PLAIN ENGLISH8. OPERATIONS169SHLEnsure that requirements documentation is consistent with actual attributes.DO DN NA170SHLEnsure that your design documentation is consistent with actual attributes.DO DN NA171SHLEnsure that your validation documentation is consistent with actual attributes.DO DN NA172SHLEnsure that your verification documentation is consistent with actual attributes.DO DN NA173SHLEnsure that your acceptance documentation is consistent with actual attributes.DO DN NA174SHLControl your configuration management process.DO DN NA8.1.3 ESTABLISH PRODUCT SAFETY MANAGEMENT PROCESSESPlan your product safety management processes.175SHLDO DN NA176SHL177SHLMake sure that safety processes are appropriate for your products.DO DN NA178SHLMake sure that safety processes apply to the entire product life cycle.DO DN NA179SHL180SHL181SHLDevelop a safety hazard assessment process.DO DN NA182SHLDevelop a safety risk management process.DO DN NA183SHLDevelop a process to manage critical safety items.DO DN NA184SHLDevelop a process to manage events that affect safety.DO DN NA185SHLDevelop a process to analyze events that affect product safety.DO DN NA186SHLDevelop a process to report events that affect product safety.DO DN NA187SHLDevelop a process to manage product safety training activities.DO DN NA188SHLDevelop a process to manage product safety communications.DO DN NA189SHLImplement your product safety management processes.DO DN NA190SHLControl your product safety management processes.DO DN NAMake sure that your safety processes are appropriate for your organization.Develop your product safety management processes.Develop a process to manage safety hazards.DO DN NAYOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:PART 8DO DN NADO DN NAORGANIZATION:JUN 2017This section is new for AS9100D.Also see section 8.1.1, above.PLAIN ENGLISH QUALITY MANAGEMENT STANDARDCOPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 84

AS9100D TRANSLATED INTO PLAIN ENGLISH8. OPERATIONS8.1.4 ESTABLISH COUNTERFEIT PART MANAGEMENT PROCESSESPlan your counterfeit part management processes.191SHLDO DN NA192SHL193SHL194SHL195SHLDevelop a process to teach people about counterfeit parts.DO DN NA196SHLDevelop a process to monitor counterfeit parts and components.DO DN NA197SHLDevelop a process to monitor obsolete parts and components.DO DN NA198SHL199SHL200SHL201SHL202SHLDevelop a process to quarantine suspicious or counterfeit parts and components.DO DN NA203SHLDevelop a process to report suspicious or counterfeit parts and components.DO DN NA204SHL205SHL206SHLImplement your counterfeit part management processes.DO DN NA207SHLTeach people about counterfeit parts and components.DO DN NA208SHLExplain how counterfeit parts can be prevented.DO DN NA209SHLExplain how suspicious parts can be detected.DO DN NA210SHL211SHLEnsure that counterfeit part management process is designed to prevent the useand inclusion of suspicious or counterfeit parts in products delivered to customers.Make sure that your counterfeit part management process is appropriatefor your organization and the products it delivers to its customers.Develop your counterfeit part management processes.Develop a process to control the acquisition of parts and components.Develop a process to detect suspicious and counterfeit parts and components.Develop methodologies to test and to verify your parts and components.Develop methodologies to detect counterfeit parts and components.Develop a process to trace parts and components back to suppliers.Ensure that you can trace them back to original or authorized manufacturers.Monitor counterfeit parts reported by external sources.DO DN NADO DN NADO DN NADO DN NADO DN NADO DN NADO DN NAMonitor suspicious and obsolete parts and components.DO DN NAYOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:PART 8DO DN NADO DN NAORGANIZATION:JUN 2017DO DN NAPLAIN ENGLISH QUALITY MANAGEMENT STANDARDCOPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 85

AS9100D TRANSLATED INTO PLAIN ENGLISH8. OPERATIONSControl the acquisition and use of parts and components.212SHLDO DN NA213SHL214SHL215SHLTest and verify parts and components and detect all counterfeit items.DO DN NA216SHLQuarantine and report suspicious or counterfeit parts and components.DO DN NA217SHL218SHLAcquire parts and components from original or authorized manufacturers.Acquire items from authorized distributors or other approved sources.Maintain a parts and components traceability process.DO DN NADO DN NADO DN NAControl your counterfeit part management processes.DO DN NA8.2 DETERMINE AND DOCUMENT PRODUCT AND SERVICE REQUIREMENTS8.2.1 COMMUNICATE WITH CUSTOMERS AND MANAGE CUSTOMER PROPERTYCommunicate with customers.219SHLDO DN NA220SHL221SHLShare information about products and services.DO DN NA222SHLDiscuss contingency plans (when relevant).DO DN NA223SHL224SHL225SHL226SHL227SHL228SHLGather customer feedback about products and services.DO DN NA229SHLGather complaints about your products and services.DO DN NA230SHL231SHL232SHLProvide information to customers.DO DN NAClarify specific requirements for actions.DO DN NAObtain information from customers.DO DN NAObtain information about orders and contracts.DO DN NAReceive information about changes to orders and contracts.Obtain information about products and services.Obtain information about property supplied by customers.Manage customer property.DO DN NADO DN NAHandle or control property supplied by customers.DO DN NAYOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:PART 8DO DN NADO DN NAORGANIZATION:JUN 2017Also see 7.4 on communication.PLAIN ENGLISH QUALITY MANAGEMENT STANDARDCOPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 86

AS9100D TRANSLATED INTO PLAIN ENGLISH8. OPERATIONS8.2.2 CLARIFY ALL PRODUCT AND SERVICE REQUIREMENTS AND CAPABILITIESDetermine requirements for products and services offered to customers.233SHL234SHLDetermine statutory and regulatory requirements for products and services.DO DN NA235SHLDetermine your organization's own requirements for products and services.DO DN NA236SHLDetermine any additional “special requirements” for products and services.DO DN NA237SHL238SHL239SHL240SHLConsider whether product or service delivery time frames can be accommodated.DO DN NA241SHLConsider whether the use of new technologies could influence your performance.DO DN NAVerify that you are capable of meeting product and service requirements.Identify the operational risks that could affect your ability to meet requirements.Consider whether you have the capacity or are capable of meeting requirements.DO DN NADO DN NADO DN NAA special requirement is onethat may be especially difficult toachieve. Special requirements maybe difficult to achieve because theyforce you to operate at the limit ofyour organization’s technical orprocess capability or at the limitof your industry’s capability.DO DN NA8.2.3 REVIEW PRODUCT AND SERVICE REQUIREMENTS AND RECORD RESULTS8.2.3.1 VERIFY REQUIREMENTS BEFORE YOU ACCEPT ORDERS FROM CUSTOMERSReview product and service requirements before you accept an view product and service requirements specified by regulatory bodies.DO DN NA249SHLReview statutory and regulatory requirements that apply in your case.DO DN NA250SHLReview product and service requirements specified by interested parties.DO DN NA251SHLReview product and service requirements specified by your organization.DO DN NA252SHLReview product and service requirements before you makea commitment to supply products and services to customers.Coordinate reviews with applicable functions within your organization.Review all documented requirements before you accept an order.Review product and service requirements specified by customers.Review delivery and post-delivery requirements before you proceed.Review all undocumented requirements before you accept an order.ORGANIZATION:YOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:JUN 2017PART 8DO DN NADO DN NADO DN NAAccording to a note to section8.2.3.1, “In some situations, suchas internet sales, a formal reviewis impractical for each order.Instead, the review can coverrelevant product information,such as catalogues or advertisingmaterial”.DO DN NADO DN NADO DN NADO DN NAPLAIN ENGLISH QUALITY MANAGEMENT STANDARDCOPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 87

AS9100D TRANSLATED INTO PLAIN ENGLISH8. OPERATIONSReview unstated requirements needed for the specified or intended use.253SHL254SHL255SHLReview all orders and contractual requirements that have been modified.DO DN NA256SHLCoordinate the review of contracts and orders that have been modified.DO DN NA257SHL258SHLNegotiate mutually acceptable requirements with customerswhenever some customer requirements cannot be met.DO DN NA259SHLAmend all relevant documented information to reflectchanges in customers’ product and service requirements.DO DN NA260SHLDistribute amended information to all relevant people.DO DN NA261SHL262SHLClarify all differences between your original proposal and the final order.Resolve all differences between your original proposal and the final order.Confirm that you can meet specified product and service requirements.Confirm that you can meet undocumented customer requirementsbefore you make a commitment to supply products and services.DO DN NADO DN NADO DN NADO DN NADO DN NA8.2.3.2 DOCUMENT YOUR REVIEW OF PRODUCT AND SERVICE REQUIREMENTS263SHL264SHL265SHL266SHLDocument the results of product and service requirement reviews.Retain and control documents that record results of requirement reviews.Document any new or changed product and service requirements.Retain and control documents that record new or changed requirements.DO DN NADO DN NADO DN NADO DN NA8.2.4 AMEND DOCUMENTS WHEN PRODUCT AND SERVICE REQUIREMENTS CHANGE267SHL268SHL269SHL270SHLControl documents that record changes in product and service requirements.Amend all relevant documented information to reflectchanges in customers' product and service requirements.DO DN NARetain documents and records that describe newor modified product and service requirements.DO DN NAShare amended information with relevant personnel.DO DN NAORGANIZATION:YOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:JUN 2017PART 8DO DN NAPLAIN ENGLISH QUALITY MANAGEMENT STANDARDCOPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 88

as9100d translated into plain english 8. operations organization: your location: completed by: date completed: jun 2017 plain english quality management standard edition 1.0 do dn na shl do dn na do dn na do dn na do dn na do dn na do dn na do dn na do dn na do