A S D T R A N S L A T E D I N T O P L A I N E N G L I S H 8. O P E R A T I O N S

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1 8.1 DEVELOP, IMPLEMENT, AND CONTROL YOUR OPERATIOL PROCESSES 1 Plan the implementation and control of your operational processes. Black identifies ISO 9001 task. 2 Consider how you're going to implement and control the processes that you need in order to meet product and service requirements. Processes were discussed in Consider how you're going to implement and control outsourced processes. See 8.4, below, for more detail. 4 Consider how you're going to perform and control the actions that you need in order to address risks and opportunities (actions are built into processes) asked you to make these actions part of your processes. 5 Consider how you're going to manage and control projects, programs, and contracts while staying on budget and on schedule. 6 Consider how you're going to plan and control the transfer of work while ensuring that risks are managed and requirements continue to be met. Blue identifies AS9100 task. 7 Consider how you're going to plan and control the permanent transfer of work. 8 Consider how you're going to plan and control the temporary transfer of work. 9 Prepare operational process implementation and control plans. 10 Carry out product and service planning activities. 11 Determine product and service requirements. 12 SHD Determine your product requirements. Blue SHD identifies AS9100 task. 13 SHD Consider product safety requirements. 14 SHD Consider personal safety requirements. 15 SHD Consider product quality requirements. 16 SHD Consider product reliability requirements. 17 SHD Consider product purity requirements. 18 SHD Consider the need to control foreign objects. 19 SHD Consider the need to detect foreign objects. 20 SHD Consider the need to remove foreign objects. PART 8 COPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 76

2 21 SHD Consider the need to prevent foreign objects. 22 SHD Consider product availability requirements. 23 SHD Consider product suitability requirements. 24 SHD Consider suitability requirements for parts and materials to be used in products. 25 SHD Consider suitability requirements for software to be embedded in products. 26 SHD Consider suitability requirements for software that you plan to purchase. 27 SHD Consider suitability requirements for software that you plan to develop. 28 SHD Consider product production requirements. 29 SHD Consider product producibility requirements. 30 SHD Consider product inspectability requirements. 31 SHD Consider product maintenance requirements. 32 SHD Consider product maintainability requirements. 33 SHD Consider product handling requirements. 34 SHD Consider product packaging requirements. 35 SHD Consider product preservation requirements. 36 SHD Consider product obsolescence requirements. 37 SHD Consider product recycling requirements. 38 SHD Consider product disposal requirements. 39 SHD Consider final disposal requirements. 40 SHD Determine your service requirements. 41 SHD Consider service safety requirements. 42 SHD Consider service reliability requirements. 43 SHD Consider service suitability requirements. PART 8 COPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 77

3 44 SHD Consider service availability requirements. 45 SHD Consider service maintainability requirements. 46 SHD Consider service endurability requirements. 47 SHD Consider service obsolescence requirements. 48 Determine criteria for products and services. Black identifies ISO 9001 task. 49 Establish acceptance criteria for products. 50 CAN Use statistical techniques to support products. Blue CAN identifies AS9100 task. 51 CAN Use statistical techniques to verify product designs. 52 CAN Use statistical techniques to verify product safety. 53 CAN Use statistical techniques to verify product reliability. 54 CAN Use statistical techniques to verify product maintainability. 55 Establish acceptance criteria for services. 56 Determine the products and services that are needed. Blue identifies AS9100 task. 57 Determine the products that external providers must provide. 58 Determine the services that external providers must provide. 59 Determine the resources needed for products and services. 60 Identify the resources needed to ensure that product requirements can be met. 61 Identify the resources needed to ensure that service requirements can be met. 62 Identify the resources needed to meet on-time delivery of products. 63 Identify the resources needed to meet on-time delivery of services. 64 Carry out process and control planning activities. 65 Select the people that should be involved in operational planning. 66 Ask people from affected organizational functions to participate. PART 8 COPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 78

4 67 Establish criteria that your operational processes should meet. 68 CAN Select statistical techniques that you can use to support processes. 69 CAN Select statistical techniques that you can use to help control processes. Blue CAN identifies AS9100 task. 70 CAN Select statistical techniques that you can use to identify key characteristics. A key characteristic is a feature or an attribute that has a significant 71 CAN Select statistical techniques that you can use to verify key characteristics. impact when it varies. Whenever a key characteristic varies, it has 72 CAN Select statistical techniques that you can use to measure process capability. an effect on the performance, form, fit, function, producibility, or service life of the product. 73 CAN Select statistical techniques that you can use to monitor process performance. Therefore, key characteristic variations must be controlled. 74 CAN Select techniques that you can use to establish statistical process control. 75 CAN Select statistical techniques that you can use to design process experiments. 76 CAN Select statistical techniques that you can use to verify process performance. 77 CAN Select statistical techniques that you can use to carry out process analyses. 78 CAN Select techniques for doing failure mode, effects, and criticality analyses. 79 Determine the processes and controls that are needed to meet requirements. 80 Determine the processes needed to support products and services. Blue identifies AS9100 task. 81 Determine processes to support the use of products and services. 82 Determine processes to support the provision of products and services. 83 Determine processes to support the maintenance of products and services. 84 Determine the processes and controls needed to manage critical items. Items are critical if they have a major impact on the provision and 85 Determine production controls when key characteristics are identified. 86 Determine the processes and controls needed to prevent unintended deliveries. 87 Determine the processes and controls needed to prevent the delivery of nonconforming products to customers. use of products and services. Items are critical if they have a significant effect on the safety, performance, form, fit, function, producibility, or life of products or services. Critical items require specific actions to ensure that they are adequately managed. 88 Determine the processes and controls needed to prevent the delivery of nonconforming services to customers. PART 8 COPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 79

5 89 Plan the management and provision of projects, programs, and contracts. 90 Ensure that projects, programs, and contracts are managed in a controlled way. 91 Make sure that projects, programs, and contracts will meet requirements at an acceptable risk and within agreed upon resource and schedule constraints. 92 Make sure that your planning outputs are suitable for your operations. 93 Establish plans to manage and control projects, programs, and contracts. 94 Describe the QMS processes that will be applied to each project, program, and contract. 95 Describe the resources that will be applied to each project, program, and contract. 96 Allocate the resources needed to support processes and projects Allocate the resources needed to manage and control your critical items. Allocate the resources needed to manage and control projects and contracts. Items are critical if they have a major impact on the provision and use of products and services. Items are critical if they have a significant 99 Allocate the resources needed to manage and control products and services. effect on the safety, performance, form, fit, function, producibility, or life of products or services. Critical 100 Allocate the resources needed to support the use of products and services. items require specific actions to ensure that they are adequately managed. 101 Allocate resources for the provision of products and services. 102 Allocate resources for the maintenance of products and services. 103 Carry out work transfer planning activities. 104 Make sure that risks are managed and requirements continue to be met. 105 Plan how you're going to manage and control the transfer of work. Also see sections 8.4 and Plan how you're going to transfer work within your own organization. 107 Plan how you're going to transfer work to and from external providers. 108 Plan how you're going to transfer work between external providers. 109 Use your plans to implement and control operational processes. 110 Implement the processes and projects that your organization needs in order to meet product and service requirements. PART 8 COPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 80

6 111 Control your product and service oriented processes and projects. 112 Use your plans and criteria to control your organization's processes and projects. 113 Use your plans and criteria to control outsourced processes and projects. Also see section 8.4, below. 114 Control changes in the processes and projects that your organization needs in order to meet product and service requirements. 115 Control planned process and project changes and modifications. 116 Review uncontrolled process and project modifications. 117 Review all unintended effects and consequences. 118 Mitigate adverse effects and consequences. 119 Retain operational process planning and control documents and records. 120 Retain and maintain documented information that can demonstrate that your processes and projects have been carried out as planned. 121 Control documents and records that monitor how your organization s processes and projects are performing. 122 Retain and maintain documented information that can show that your products and services meet requirements. 123 Control documents and records that monitor and control product and service conformity ESTABLISH AN OPERATIOL RISK MAGEMENT PROCESS 124 Plan your operational risk management process. Within the aviation, space, and defense industry, a risk is an 125 Develop a process to manage your operational risks. 126 Make sure that your risk management process is appropriate for your organization and the products and services it provides. 127 Plan the assignment of risk management responsibilities. 128 Clarify and define your operational risk assessment criteria. 129 Figure out how you re going to determine the likelihood of an occurrence. event or outcome that has two characteristics: it is both likely to occur and likely to have severe consequences. While risk management is discussed in both section 6.1 and 8.1, the focus is different. While section 6.1 asks you to consider the risks and opportunities that could influence the performance of your QMS, section 8.1, on the other hand, asks you to consider the operational risks related to the provision of products and services. PART 8 COPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 81

7 130 Figure out how you re going to evaluate potentially negative consequences. 131 Figure out how you re going to make operational risk acceptance decisions Describe how operational risks will be managed. Figure out how operational risks will be identified. Figure out how operational risks will be assessed. A note in section of AS9100D says that Within the aviation, space, and defense industry, risk is expressed in terms of the likelihood of occurrence and the severity of the consequences. 135 Figure out how operational risks will be communicated. 136 Specify how risk management initiatives will be taken. 137 Figure out how to manage the actions that must be taken to mitigate the operational risks that exceed the limits set by your risk acceptance criteria. This approach to risk asks two fundamental questions: what is the probability that a potential event will occur in the future? And what consequences would this event produce or what impact would it have if it actually occurred? 138 Figure out how you re going to identify the actions that must be taken to mitigate operational risks. 139 Figure out how you re going to implement the actions that must be taken to mitigate operational risks. 140 Define how residual operational risks will be controlled. 141 Figure out how you re going to control the acceptable operational risks that remain after you ve taken action to mitigate unacceptable risks. 142 Implement your operational risk management process. 143 Assign operational risk management responsibilities. 144 Manage your product and service management risks. 145 Identify your product and service management risks. 146 Assess your product and service management risks. 147 Determine the likelihood that events will occur. 148 Determine the likelihood or probability that an undesirable occurrence or outcome will actually occur in the future. 149 Evaluate potentially severe consequences. 150 Make operational risk acceptance decisions. PART 8 COPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 82

8 151 Communicate your product and service management risks. 152 Apply the actions that must be taken to mitigate the operational risks that exceed the limits set by your risk acceptance criteria. 153 Identify the actions that must be taken to mitigate operational risks. 154 Implement the actions that must be taken to mitigate operational risks. 155 Control the risks that remain after you ve implemented actions to mitigate unacceptable operational risks. 156 Control your operational risk management process. 157 Make sure that your operational risk management process is appropriate for your organization. 158 Make sure that your operational risk management process is appropriate for your organization s products and services ESTABLISH A CONFIGURATION MAGEMENT PROCESS 159 Plan your configuration management process. Blue identifies AS9100 task. 160 Make sure that your configuration management process can be used to identify and control physical and functional attributes throughout the product and service lifecycle. 161 Make sure that your configuration management process is appropriate for your organization and the products and services it provides. 162 Implement your configuration management process. 163 Use your configuration management process to identify and control your organization s product and service attributes. 164 Control product and service identities and characteristics. 165 Control product and service traceability to requirements. 166 Control product and service changes and modifications. 167 Control product and service documents and records. 168 Make sure that your product and service documents and records are consistent with the actual attributes of your products and services. PART 8 COPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 83

9 169 Ensure that requirements documentation is consistent with actual attributes. 170 Ensure that your design documentation is consistent with actual attributes. 171 Ensure that your validation documentation is consistent with actual attributes. 172 Ensure that your verification documentation is consistent with actual attributes. 173 Ensure that your acceptance documentation is consistent with actual attributes. 174 Control your configuration management process ESTABLISH PRODUCT SAFETY MAGEMENT PROCESSES 175 Plan your product safety management processes. This section is new for AS9100D. 176 Make sure that your safety processes are appropriate for your organization. 177 Make sure that safety processes are appropriate for your products. 178 Make sure that safety processes apply to the entire product life cycle. 179 Develop your product safety management processes. 180 Develop a process to manage safety hazards. 181 Develop a safety hazard assessment process. 182 Develop a safety risk management process. Also see section 8.1.1, above. 183 Develop a process to manage critical safety items. 184 Develop a process to manage events that affect safety. 185 Develop a process to analyze events that affect product safety. 186 Develop a process to report events that affect product safety. 187 Develop a process to manage product safety training activities. 188 Develop a process to manage product safety communications. 189 Implement your product safety management processes. 190 Control your product safety management processes. PART 8 COPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 84

10 8.1.4 ESTABLISH COUNTERFEIT PART MAGEMENT PROCESSES 191 Plan your counterfeit part management processes. 192 Ensure that counterfeit part management process is designed to prevent the use and inclusion of suspicious or counterfeit parts in products delivered to customers. 193 Make sure that your counterfeit part management process is appropriate for your organization and the products it delivers to its customers. 194 Develop your counterfeit part management processes. 195 Develop a process to teach people about counterfeit parts. 196 Develop a process to monitor counterfeit parts and components. 197 Develop a process to monitor obsolete parts and components. 198 Develop a process to control the acquisition of parts and components. 199 Develop a process to detect suspicious and counterfeit parts and components. 200 Develop methodologies to test and to verify your parts and components. 201 Develop methodologies to detect counterfeit parts and components. 202 Develop a process to quarantine suspicious or counterfeit parts and components. 203 Develop a process to report suspicious or counterfeit parts and components. 204 Develop a process to trace parts and components back to suppliers. 205 Ensure that you can trace them back to original or authorized manufacturers. 206 Implement your counterfeit part management processes. 207 Teach people about counterfeit parts and components. 208 Explain how counterfeit parts can be prevented. 209 Explain how suspicious parts can be detected. 210 Monitor counterfeit parts reported by external sources. 211 Monitor suspicious and obsolete parts and components. PART 8 COPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 85

11 212 Control the acquisition and use of parts and components. 213 Acquire parts and components from original or authorized manufacturers. 214 Acquire items from authorized distributors or other approved sources. 215 Test and verify parts and components and detect all counterfeit items. 216 Quarantine and report suspicious or counterfeit parts and components. 217 Maintain a parts and components traceability process. 218 Control your counterfeit part management processes. 8.2 DETERMINE AND DOCUMENT PRODUCT AND SERVICE REQUIREMENTS COMMUNICATE WITH CUSTOMERS AND MAGE CUSTOMER PROPERTY 219 Communicate with customers. Also see 7.4 on communication. 220 Provide information to customers. 221 Share information about products and services. 222 Discuss contingency plans (when relevant). 223 Clarify specific requirements for actions. 224 Obtain information from customers. 225 Obtain information about orders and contracts. 226 Receive information about changes to orders and contracts. 227 Obtain information about products and services. 228 Gather customer feedback about products and services. 229 Gather complaints about your products and services. 230 Obtain information about property supplied by customers. 231 Manage customer property. 232 Handle or control property supplied by customers. PART 8 COPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 86

12 8.2.2 CLARIFY ALL PRODUCT AND SERVICE REQUIREMENTS AND CAPABILITIES 233 Determine requirements for products and services offered to customers. 234 Determine statutory and regulatory requirements for products and services. 235 Determine your organization's own requirements for products and services Determine any additional special requirements for products and services. Verify that you are capable of meeting product and service requirements. A special requirement is one that may be especially difficult to achieve. Special requirements may be difficult to achieve because they 238 Identify the operational risks that could affect your ability to meet requirements. force you to operate at the limit of your organization s technical or process capability or at the limit of your industry s capability. 239 Consider whether you have the capacity or are capable of meeting requirements. 240 Consider whether product or service delivery time frames can be accommodated. 241 Consider whether the use of new technologies could influence your performance REVIEW PRODUCT AND SERVICE REQUIREMENTS AND RECORD RESULTS VERIFY REQUIREMENTS BEFORE YOU ACCEPT ORDERS FROM CUSTOMERS 242 Review product and service requirements before you accept an order. According to a note to section , In some situations, such 243 Review product and service requirements before you make a commitment to supply products and services to customers. 244 Coordinate reviews with applicable functions within your organization. 245 Review all documented requirements before you accept an order. 246 Review product and service requirements specified by customers. 247 Review delivery and post-delivery requirements before you proceed. 248 Review product and service requirements specified by regulatory bodies. 249 Review statutory and regulatory requirements that apply in your case. 250 Review product and service requirements specified by interested parties. 251 Review product and service requirements specified by your organization. 252 Review all undocumented requirements before you accept an order. as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information, such as catalogues or advertising material. PART 8 COPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 87

13 253 Review unstated requirements needed for the specified or intended use. 254 Clarify all differences between your original proposal and the final order. 255 Review all orders and contractual requirements that have been modified. 256 Coordinate the review of contracts and orders that have been modified. 257 Resolve all differences between your original proposal and the final order. 258 Negotiate mutually acceptable requirements with customers whenever some customer requirements cannot be met. 259 Amend all relevant documented information to reflect changes in customers product and service requirements. 260 Distribute amended information to all relevant people. 261 Confirm that you can meet specified product and service requirements. 262 Confirm that you can meet undocumented customer requirements before you make a commitment to supply products and services DOCUMENT YOUR REVIEW OF PRODUCT AND SERVICE REQUIREMENTS 263 Document the results of product and service requirement reviews. 264 Retain and control documents that record results of requirement reviews. 265 Document any new or changed product and service requirements. 266 Retain and control documents that record new or changed requirements AMEND DOCUMENTS WHEN PRODUCT AND SERVICE REQUIREMENTS CHANGE 267 Control documents that record changes in product and service requirements. 268 Amend all relevant documented information to reflect changes in customers' product and service requirements. 269 Retain documents and records that describe new or modified product and service requirements. 270 Share amended information with relevant personnel. PART 8 COPYRIGHT 2017 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 88