An Overview. of the. TL 9000 Standard

Transcription

1 An Overview of the TL 9000 Standard

2 Objectives To provide an overview of the TL 9000 rev. 5 requirements and to show how these fit into the ISO 9001 framework. To provide an understanding of the terminology and activities associated with a TL 9000 quality management system. 2 QBS Quality Business Solutions Inc.

3 TL 9000 Background TL 9000 is a quality management standard designed by the QuEST Forum in 1998 to enhance quality management practices across the telecommunications section. It defines a set of performance-based measurements to evaluate the results of QMS implementation. QBS Quality Business Solutions Inc. 3

4 TL 9000 Background QuEST Forum is a collaboration of information and communication technologies (ICT) service providers and suppliers across the world who are dedicated to improving operational and supply chain quality and performance. It provides benchmarking data to participating companies against a set of defined measurements. QBS Quality Business Solutions Inc. 4

5 Fitting into the ISO 9001 Framework. ISO 9001 is intended to be compatible with other internationally recognized standards: Currently aligned with ISO for Environmental Management, QuEST Form has made the commitment to keep pace with the ISO 9001 Standard. QBS Quality Business Solutions Inc. 5

6 Scope of ISO 9001 The ISO 9001 standard specifies requirements for a Quality Management system where an organization needs: To demonstrate ability to consistently provide product that meets customer and applicable statutory and regulatory requirements. To enhance customer satisfaction through effective application of the system including processes for continual improvement and the assurance of conformity to customer and applicable regulatory requirements. QBS Quality Business Solutions Inc. 6

7 TL 9000 Scope What is different with TL 9000? TL 9000 encompasses ALL requirements of ISO 9001 plus: Add-on requirements applicable to the telecom industry; Requirements for collection of metrics and reporting of metrics to a central repository. QBS Quality Business Solutions Inc. 7

8 TL 9000 Scope What is different with TL 9000? The standard is contained in 2 separate publications: The TL 9000 Quality Management System Requirements Handbook (rev. 5), and The TL 9000 Quality Management System Measurements Handbook (rev. 5). QBS Quality Business Solutions Inc. 8

9 TL 9000 Measurements Defined by: Product Category Measurement Handbook lists Product Categories and applicable metrics. The Product Category sets the terms for data collection and submission. Application to Hardware, Software and Service. QBS Quality Business Solutions Inc. 9

10 TL 9000 Scope Hardware Add-on requirements have an H in the requirement number. Software Add-on requirements have an S in the requirement number. Service Add-on requirements have a V in the requirement number. Common Add-on requirements are denoted by a C. QBS Quality Business Solutions Inc. 10

11 Review of the Standard The following slides will provide an overview of the requirements of the ISO 9001 and TL 9000 standards. QBS Quality Business Solutions Inc. 11

12 4 Quality Management System Requirements 4.1 General Requirements 4.2 Documentation Requirements QBS Quality Business Solutions Inc. 12

13 4.1 General requirements The organization shall: establish, document, implement, maintain and continuously improve the QMS Identify processes needed for QMS Determine sequence and interaction Determine criteria and methods for control to ensure the processes are effective Ensure resources and supporting information is available Monitor, measure and analyze processes Implement action for continual improvement Ensure and identify control over processes that are outsourced. QBS Quality Business Solutions Inc. 13

14 TL 9000 Add-On Requirements For 4.1 General Requirements None QBS Quality Business Solutions Inc. 14

15 4.2 Documentation Requirements General QMS documentation shall include: Quality policy and quality objectives Quality manual Required documented procedures Documents needed by the organization Records required by this standard. QBS Quality Business Solutions Inc. 15

16 4.2.2 Quality Manual The organization shall establish and maintain a manual to include: Scope of the QMS Details/justification for any exclusions Documented procedures or references Description of the interaction of the QMS processes. QBS Quality Business Solutions Inc. 16

17 4.2.3 Control of Documents QMS documents shall be controlled. A Procedure needs to be established to control: Approval prior to issue Review, update and re-approval Identification of changes and current revision Relevant versions available at points of use Legible and readily identifiable External documents Obsolete documents. QBS Quality Business Solutions Inc. 17

18 TL 9000 Add-On Requirements For Control of Documents C.1 The organization must have a procedure for the control of customer-supplied documents and data. QBS Quality Business Solutions Inc. 18

19 4.2.4 Control of Records Records shall be established and maintained as evidence of conformance to requirements Records will remain legible, readily identifiable and retrievable Documented procedure must be established for: Identification storage retrieval Protection retention time disposition. QBS Quality Business Solutions Inc. 19

20 5.1 Management commitment Top management shall provide evidence of commitment to develop and improve the QMS effectiveness: Communicate the importance of meeting requirements Establish the quality policy Ensure quality objectives are established Conduct management reviews Ensure availability of resources. QBS Quality Business Solutions Inc. 20

21 5.2 Customer Focus Top management shall ensure: Customer requirements are determined and met with the aim of enhancing customer satisfaction. QBS Quality Business Solutions Inc. 21

22 TL 9000 Add-On Requirements For 5.2 Customer Focus 5.2.C.1 Top management shall demonstrate active involvement in establishing and maintaining mutuallybeneficial relationships between the organization and its customers. 5.2.C.2 The organization shall establish methods for communicating with selected customers to share expectations and to ensure product quality improvement. The outcome of these communications should generate actions for resolving identified issues. QBS Quality Business Solutions Inc. 22

23 5.3 Quality Policy Top management shall ensure policy: Is appropriate to the purpose of the organization Includes commitment to comply with requirements and continually improve the QMS Provides a framework for quality objectives Is communicated and understood internally Is reviewed for continuing suitability. QBS Quality Business Solutions Inc. 23

24 5.4 Planning Quality Objectives Top management shall ensure quality objectives are: Established at relevant functions and levels Are measurable and consistent with quality policy Quality Objectives include those needed to meet product requirements QBS Quality Business Solutions Inc. 24

25 TL 9000 Add-On Requirements For Quality Objectives C.1 Quality Objectives must include targets for TL 9000 measurements. Measurements are defined in the TL 9000 Quality Management System Measurement Handbook by product category. QBS Quality Business Solutions Inc. 25

26 TL 9000 Common Measurements The following measurements are applicable to all product categories: NPR number of problem reports FRT problem report fix time OFR overdue problem report fix responsiveness OTD on-time delivery QBS Quality Business Solutions Inc. 26

27 TL 9000 Common Measurements Each type of measurement has rules for calculation and counting: e.g. NPR (# Problem Reports): > count # Minor, Major and Critical PRs > for defined calculation periods > normalized > based on NPRs per unit or per network, as described in measurement tables. QBS Quality Business Solutions Inc. 27

28 TL 9000 Common Measurements Critical PR condition that severely impacts primary functionality of the product Major PR product is usable, but product is seriously degraded. Minor PR all else. **Customer generally determines severity level. QBS Quality Business Solutions Inc. 28

29 TL 9000 Measurements Other examples: Service Impact Outage Measurement (SO) Software Fixed Quality Measurement (SFQ) Field Replaceable Unit Returns Measurement (FR) QBS Quality Business Solutions Inc. 29

30 TL 9000 Measurements - FR FR breaks down into Early Return Index (returns during 1 st 6 months) One-Year Return Index (returns after 6-18 months) Long-term Return Index (19 or more months) QBS Quality Business Solutions Inc. 30

31 5.4.2 Quality Management System Planning Top management shall ensure: Planning is carried out to meet requirements of 4.1 To meet quality objectives To maintain integrity of the QMS during times of change to the QMS. QBS Quality Business Solutions Inc. 31

32 TL 9000 Add-On Requirements For QMS Planning C.1 - The organization's quality planning activities shall include long- and short-term plans with goals for improving quality and customer satisfaction C.2 Customer Input - The organization shall implement methods for soliciting and considering customer input for quality planning activities C.3 Supplier Input - The organization shall implement methods for soliciting and using supplier input for quality planning activities. QBS Quality Business Solutions Inc. 32

33 5.5.1 Responsibility and Authority Top management shall: Define responsibilities and authorities Communicate these within the organization. QBS Quality Business Solutions Inc. 33

34 5.5.2 Management Representative Appointed by top management from the organization s management Has responsibility and authority to: Ensure processes for QMS are established, implemented and maintained Report to top management on performance of QMS, and any need for improvement Ensure the promotion of awareness of customer requirements. QBS Quality Business Solutions Inc. 34

35 5.5.3 Internal Communication Top management shall ensure appropriate communication processes are established within the organization and that communication takes place regarding effectiveness of the QMS QBS Quality Business Solutions Inc. 35

36 TL 9000 Add-On Requirements For Internal Communication 5.3.C.1 Organization Performance Feedback - The organization shall inform employees of its quality performance and the level of customer satisfaction, including the results of quality management system reviews. QBS Quality Business Solutions Inc. 36

37 5.6 Management Review General Top management shall: Perform reviews of the QMS Conduct these reviews at planned intervals Ensure the QMS is suitable, adequate and effective Assess opportunities for improvement and the need for any system changes Evaluate changes to policy and objectives. Records of management reviews are required. QBS Quality Business Solutions Inc. 37

38 5.6.2 Review Input Input to Management Review: Results of audits Customer feedback Process performance and product conformity Status of preventive and corrective actions Follow-up actions from previous reviews Planned changes that could affect the QMS Recommendations for improvement. QBS Quality Business Solutions Inc. 38

39 5.6.3 Review Output Review output shall include decisions and take actions related to: Improvement of the effectiveness of the QMS and its processes Improvement of product related to customer requirements Resource needs. QBS Quality Business Solutions Inc. 39

40 TL 9000 Add-On Requirements For 5.6 Management Review None QBS Quality Business Solutions Inc. 40

41 6.1 Provision of Resources The organization shall determine and provide resources needed to: Implement and maintain the QMS Continually improve its effectiveness Enhance customer satisfaction. QBS Quality Business Solutions Inc. 41

42 6.2 Human Resources General The organization shall select and assign competent personnel for positions doing work affecting product quality. Competence is based on: Appropriate education Training Skills Experience QBS Quality Business Solutions Inc. 42

43 6.2.2 Competence, awareness and training The organization shall: Identify competency needs Provide training or take other actions to satisfy these needs Evaluate effectiveness of actions taken Inform employees of the importance of their work Ensure they understand how they contribute to the quality objectives. Records of education, training, skills and experience are required. QBS Quality Business Solutions Inc. 43

44 TL 9000 Add-On Requirements For Competence, Training and Awareness C.1 The organization shall ensure consistency in course planning, development, and delivery for internally developed courses C.2 Those employees who have a direct impact on the quality of the product, including top management, shall be trained in and apply the fundamental concepts of continual improvement, problem solving, and customer satisfaction C.3 The organization shall ensure employees are enabled to participate in product quality training. QBS Quality Business Solutions Inc. 44

45 TL 9000 Add-On Requirements For Competence, Training and Awareness CONT C.4 All employees with functions that involve handling, storage, packaging, preservation, or delivery of ESD-sensitive products shall receive training in ESD protection prior to performing their jobs C.5 The organization shall offer appropriate levels of advanced quality training C.6 Where applicable, staff shall receive training on Hazardous Conditions. QBS Quality Business Solutions Inc. 45

46 TL 9000 Add-On Requirements For Competence, Training and Awareness CONT HV.1 Where applicable, criteria shall be established for qualification and re-qualification of personnel HV.1-NOTE Examples of processes which may require personnel qualification and re-qualification include wire wrapping, soldering, welding, and laboratory processes. QBS Quality Business Solutions Inc. 46

47 6.3 Infrastructure The organization needs to determine, provide and maintain the infrastructure needed to achieve product conformity including: Buildings, workspace and associated facilities Process equipment (hardware and software) Supporting services (transport or communication) QBS Quality Business Solutions Inc. 47

48 TL 9000 Add-On Requirements For 6.3 Infrastructure 6.3.C.1 The organization shall identify critical areas of the infrastructure and provide for the security needed to protect these areas. > this can be done for example on a coded security map, with personnel keys linked to specific code zones. QBS Quality Business Solutions Inc. 48

49 6.4 Work Environment The organization needs to: Identify work environment factors that affect product conformity to requirements Manage these factors as needed to achieve product conformity. QBS Quality Business Solutions Inc. 49

50 TL 9000 Add-On Requirements For 6.4 Work Environment 6.4.C.1 Areas used for handling, storage, and packaging of products shall be clean, safe, and organized to ensure that they do not adversely affect product quality or personnel performance. QBS Quality Business Solutions Inc. 50

51 7.1 Planning of Product Realization Processes need to be planned and developed consistent with QMS requirements. Determine as appropriate: Quality objectives and requirements Necessary processes and product resources Monitoring, inspection/test, verification and validation activities and criteria for acceptability Records for evidence of conformity. QBS Quality Business Solutions Inc. 51

52 TL 9000 Add-On Requirements For 7.1 Planning of Product Realization 7.1.C.1 The organization shall establish and maintain a life cycle model(s) for its products. 7.1.C.2 The organization shall establish and maintain documented plans for disaster recovery and security restoration. 7.1.C.3 The organization shall establish and maintain a documented procedure for the discontinuance of manufacturing and/or support of a product. QBS Quality Business Solutions Inc. 52

53 TL 9000 Add-On Requirements More on the Disaster Recovery Plan 7.1.C.2 DR Plan shall enable ability to recreate and service the product throughout its life cycle. DR Plan shall include crisis management, business continuity and information management. DR Plan shall be periodically evaluated for effectiveness. QBS Quality Business Solutions Inc. 53

54 TL 9000 Add-On Requirements For 7.1 Planning of Product Realization 7.1.C.4 Tools Management - The organization shall ensure that internally developed software and/or tools used in the product life cycle are controlled. 7.1.HS.1 The organization shall establish and maintain a configuration management plan. 7.1.V.1 Service Delivery Plan - The delivery or implementation of a service shall comply with the Project Plan and Risk Management requirements (7.3.1.C.1, C.4). QBS Quality Business Solutions Inc. 54

55 7.2 Customer-related Processes Determination of requirements related to the product The organization shall determine: Requirements specified by the customer including delivery and post-delivery activity Requirements not stated by the customer but necessary for specific or intended use Statutory or regulatory requirements Any additional requirements determined by the organization. QBS Quality Business Solutions Inc. 55

56 7.2.2 Review of Requirements related to Product The organization shall review requirements before committing to supply a product to a customer and shall: Ensure requirements are defined Resolve any differences from initial order Ensure you has ability to meet requirements Confirm requirements when not documented by the customer Amend documents to reflect any changes Maintain Records of reviews and follow up actions. QBS Quality Business Solutions Inc. 56

57 TL 9000 Add-On Requirements For 7.2 Review of Requirements Related to Product C.1 Closure Tracking - All actions resulting from requirements reviews shall be tracked to closure C.2 Contract Review - The organization shall establish and maintain a contract review process that should include. next slide QBS Quality Business Solutions Inc. 57

58 TL 9000 Add-On Requirements More on Contract Review C.2 Contract review process should include: product acceptance criteria, methods of handling problems after contract award, plans for correction of NCRs after warranty, risks, contingencies, protection of proprietary information, customer s responsibilities and facilities/tools to be provided, Referenced standards and procedures. QBS Quality Business Solutions Inc. 58

59 7.2.3 Customer Communication The organization shall determine and implement effective arrangements for communicating with customers relative to: Product information Inquiries, contracts, order handling, and amendments Customer feedback, including complaints. QBS Quality Business Solutions Inc. 59

60 TL 9000 Add-On Requirements For Customer Communication C.1 The organization shall establish and maintain a documented procedure to notify all customers who may be affected by a Critical Problem Report C.2 The organization shall assign severity levels to customer-reported problems based on the impact to the customer: critical, major, and minor problems. The severity level shall be used in determining the timeliness of the organization's response. QBS Quality Business Solutions Inc. 60

61 TL 9000 Add-On Requirements For Customer Communication C.3 Problem Escalation -The organization shall establish and maintain a documented escalation procedure to resolve customer-reported problems C.4 Problem Report Feedback The organization shall provide the customer with feedback on their problem reports in a timely and systematic manner HS.1 Product Replacement The organization shall establish and maintain a documented procedure for identifying and replacing products that are unfit to remain in service. QBS Quality Business Solutions Inc. 61

62 TL 9000 Add-On Requirements More on providing timely feedback on reported PRs The standard common metric FRT Problem Report Fixed Response Time explains what timely means in specific terms. For product categories 1 through 5.. >major problems due within 30 days >minor problems due within 180 days > critical problems require non-stop immediate corrective action regardless of time of day or day of the week QBS Quality Business Solutions Inc. 62

63 TL 9000 Add-On Requirements For Customer Communication CONT HS.2 On customer request, the organization shall report on a set of jointly agreed design/development process measures. QBS Quality Business Solutions Inc. 63

64 7.3 Design and development Design and development planning The organization shall: Plan and control product design/development Determine stages of design/development Set review, verification, validation activities Establish responsibility and authority Manage interfaces between involved groups Ensure effective communication and roles Update plan output as design progresses. QBS Quality Business Solutions Inc. 64

65 TL 9000 Add-On Requirements For Design and Development Planning C.1 The organization's project planning activities shall be based on the defined product life cycle model. The project plan should include: a) project organizational structure, b) roles, responsibilities, and accountabilities of the project team, c) roles, responsibilities, and accountabilities of related teams or individuals, within and outside the organization, and interfaces between them and the project team, d) means for scheduling, tracking, issue resolution, and management reporting, e) budgets, staffing, and schedules associated with project activities, f) identification of method(s), standards, documented procedure(s), and tools to be used (If such items are clearly defined as part of the product life cycle model, a reference to that life cycle model is sufficient.), g) references to related plans (e.g., risk management, development, testing, configuration management, and quality),.. QBS Quality Business Solutions Inc. 65

66 TL 9000 Add-On Requirements For Design and Development Planning CONT. h) project-specific development or service delivery environment and physical resource considerations (e.g., resources to address development, user documentation, testing, operation, required development tools, secure computing environment, lab space, workstations, etc.), i) customer, user, and supplier involvement during the product life cycle (e.g., joint reviews, informal meetings, and approvals), j) management of project quality, including appropriate quality measures, k) design for 'x' plans as appropriate to the product life cycle (Plan examples include, but are not limited to, Manufacturability, Reliability, Regulatory, Serviceability, Safety, Sustainability, and Testability.), I) lessons learned from previous post-project analyses, m) project-specific training requirements, n) required certifications (e.g., product certifications or employee technical certifications), 0) proprietary, usage, ownership, warranty, licensing rights, and p) post-project analysis and improvement activities, including root cause analysis of project lessons learned, and corrective actions to be taken to preclude repetition in future projects. QBS Quality Business Solutions Inc. 66

67 TL 9000 Add-On Requirements For Design and Development Planning CONT C.2 Requirements Traceability - The organization shall establish and maintain a method to trace documented requirements through design and test C.3 Test plans shall be documented and should include a) through l) C.4 The organization shall develop and document a risk management plan which should include next slide QBS Quality Business Solutions Inc. 67

68 TL 9000 Add-On Requirements More on Risk Management Plan C.4 The Risk Management Plan should be done through all phases of development and include: Determination of risk categories, probability vs severity ratings Identification of critical failure modes Means of managing risks Inputs from other disciplines Mechanism for capturing lessons learned. QBS Quality Business Solutions Inc. 68

69 TL 9000 Add-On Requirements For Design and Development Planning CONT C.5 Integration Planning - The organization shall develop and document a plan to integrate the hardware, software, and/or service components into the product to ensure they interact as designed C.6 Estimation - The organization shall establish and maintain a method for estimating and tracking project factors against the project plan throughout the project life cycle HS.1 Migration Planning - The organization shall develop and document a migration plan when a system, hardware or software product is planned to be migrated from an old to a new operational environment. QBS Quality Business Solutions Inc. 69

70 TL 9000 Add-On Requirements For Design and Development Planning CONT HS.2 During the design and development planning phase, the organization shall establish and maintain a method for selecting and reporting appropriate design and development process quality measures for the project S.1 Computer Resources - The organization shall establish and maintain methods for estimating and tracking critical computer resources for the target computer, the computer on which the software is intended to operate. QBS Quality Business Solutions Inc. 70

71 TL 9000 Add-On Requirements For Design and Development Planning CONT S.2 Regression Test Planning - If regression testing is to be performed, test plans shall specify which tests are regression and what features and functions are covered by these regression tests. QBS Quality Business Solutions Inc. 71

72 7.3.2 Design/Development Inputs Design/development inputs shall include: Functional and performance requirements Applicable regulatory and statutory requirements Applicable information derived from similar designs Other essential requirements Inputs reviewed for adequacy Complete, unambiguous, not in conflict Records of design inputs required. QBS Quality Business Solutions Inc. 72

73 TL 9000 Add-On Requirements For Design and Development Inputs C.1 Customer and Supplier Input - The organization shall establish and maintain methods for soliciting and using customer and supplier input during the development of new or revised product requirements C.2 Design and development requirements shall be defined and documented, and should include (note these are C requirements!): a) quality and reliability requirements, b) functions and capabilities of the product, c) business, organizational, and user requirements, d) safety, environmental, sustainability and security requirements, e) manufacturability, installability, usability, interoperability, and maintainability requirements, f) design constraints, g) testing requirements, h) computer resources for the target computer, and i) lessons learned from previous projects. QBS Quality Business Solutions Inc. 73

74 TL 9000 Add-On Requirements For Design and Development Inputs CONT C.3 Requirements Allocation - The organization shall document the allocation of the product requirements to the product architecture H.1 Content of Requirements - The product requirements shall include, but are not limited to a) nominal values and tolerances, b) maintainability needs, and c) end-item packaging requirements S.1 Identification of Software Requirements - The organization shall determine, analyze, and document the software component requirements of the system. QBS Quality Business Solutions Inc. 74

75 7.3.3 Design/Development Outputs Provide outputs to enable verification Approved prior to release Outputs must: Meet input requirements Provide information for purchasing, production and service Contain or reference product acceptance criteria Specify characteristics for safe and proper use. QBS Quality Business Solutions Inc. 75

76 TL 9000 Add-On Requirements For Design and Development Outputs HS.1 Design and development outputs should include, but are not limited to: a) system architecture, b) system detailed design, c) source code, and d) user documentation V.1 The required output from the services design and development shall contain a complete and precise statement of the service to be provided as well as: a) service delivery procedures, b) resource and skill requirements, c) reliance on suppliers, d) service characteristics subject to customer evaluation, and e) standards of acceptability for each service characteristic. QBS Quality Business Solutions Inc. 76

77 7.3.4 Design/Development Review Systematic reviews of design shall be performed at suitable stages, in order to: Evaluate ability to fulfill requirements Identify problems and propose necessary actions Reviews must include representatives from concerned groups. Records of results of reviews and any necessary actions must be maintained. QBS Quality Business Solutions Inc. 77

78 TL 9000 Add-On Requirements For Design/Development Review None QBS Quality Business Solutions Inc. 78

79 7.3.5 Design/Development Verification Design Verification shall be performed, in accordance with planned arrangements Verification shall ensure outputs have met input requirements Records of the results of verification and necessary actions required shall be maintained. QBS Quality Business Solutions Inc. 79

80 TL 9000 Add-On Requirements For Design/Development Verification C.1 Verification of Documentation - The organization shall verify the customer and/or user documentation prior to product delivery HS.1 Stress Testing - The organization shall test the product under stress conditions, including, but not limited to, out-of-boundary and invalid input conditions, high volume and peak load simulations, and operational errors. QBS Quality Business Solutions Inc. 80

81 TL 9000 Add-On Requirements For Design/Development Verification CONT HS.2 Abnormal Conditions - The organization shall test the product under abnormal conditions, which shall include, as appropriate a) hardware errors, b) software errors, c) operations, administration, maintenance and provisioning errors, d) overload traffic, e) invalid user input, and f) system recovery from an outage S.1 System Testing - Each software release shall be subjected to a system test in accordance with a documented system test plan. QBS Quality Business Solutions Inc. 81

82 7.3.6 Design/Development Validation Design/development validation shall: Be performed in accordance with a plan; Ensure product meets requirements for the specified application; Be complete before delivery or implementation when practical. Records of results of validation and necessary actions must be maintained. QBS Quality Business Solutions Inc. 82

83 TL 9000 Add-On Requirements For Design/Development Validation S.1 Release Management - The organization shall establish and maintain a method to ensure that the release and delivery of software products and related documentation are carried out under controlled conditions. Methods should provide for the delivery to the customer of: a) release planning information in advance of the release, b) product introduction and release schedules, c) detailed descriptions of product features delivered, including any changes incorporated in new software products or releases, and d) advisories regarding current or planned changes to contractual terms. QBS Quality Business Solutions Inc. 83

84 7.3.7 Control of Design/Development Changes The organization shall: Identify and keep records of design/development changes; Evaluate effect on constituent parts and product already delivered; Review, verify and validate changes as appropriate; Approve changes before implementation; Keep Records of results of review and necessary actions. QBS Quality Business Solutions Inc. 84

85 TL 9000 Add-On Requirements For Control of Design/Development Changes C.1 The organization shall establish and maintain a documented procedure to ensure that all requirements and design changes, which may arise at any time during the product life cycle, are managed and tracked in a systematic and timely manner appropriate to the life cycle stage C.2 Informing Customers - The organization shall establish and maintain a documented procedure to ensure that customers are informed when design changes affect contractual commitments. QBS Quality Business Solutions Inc. 85

86 TL 9000 Add-On Requirements For Control of Design/Development Changes CONT C.3 Problem Resolution Configuration Management - The organization shall ensure that its configuration management system tracks fixes to problems and incorporates those fixes in future revisions H.1 Component Changes - The organization shall have a documented procedure in place to ensure that material or component substitutions or changes do not adversely affect conformity to product requirements or performance. Note sub requirements a) through e). QBS Quality Business Solutions Inc. 86

87 7.4 Purchasing Purchasing process The organization shall control the purchasing process to ensure purchased product conforms to requirements. Base type and extent of control upon effect on the realization processes and output Evaluate and select suppliers based on their ability to supply product to requirements Establish criteria for selection, evaluation and reevaluation Record results of supplier evaluations and necessary actions. QBS Quality Business Solutions Inc. 87

88 TL 9000 Add-On Requirements For Purchasing Process C.1 The organization shall establish and maintain a documented purchasing procedure C.2 The organization shall plan and perform supplier performance management so that: a) suppliers are qualified to established criteria, b) evaluation results are considered during supplier selection activities, c) suppliers are periodically re-evaluated using established criteria, d) supplier quality performance is tracked and feedback is provided to suppliers to drive continual improvement, and e) for identified key suppliers, alignment toward conformity to TL 9000 requirements occurs. QBS Quality Business Solutions Inc. 88

89 7.4.2 Purchasing Information Information must describe the product to be purchased. As appropriate, include the qualification or approval requirements for: Products, procedures, processes and equipment Qualification of personnel QMS requirements Ensure adequacy before communicating to the supplier. QBS Quality Business Solutions Inc. 89

90 7.4.3 Verification of purchased product/services The organization shall: Identify and implement inspection or other activities to ensure purchased product meets requirements. For verification at supplier premises by the customer, or by the organization, the organization shall specify the terms in a contract or other purchasing document. QBS Quality Business Solutions Inc. 90

91 7.5 Production and Service Provision Control of Production and Service Provision The organization shall plan and carry out activities under controlled conditions, including as applicable: Availability of product characteristics (e.g. drawings) Availability of work instructions, as necessary Use of suitable equipment Use of measuring and monitoring devices Implementation of monitoring and measurement Implementation of defined processes for release, delivery, and post-delivery activities. QBS Quality Business Solutions Inc. 91

92 TL 9000 Add-On Requirements For Control of Production and Servicing C.1 Service Resources - The organization shall provide customer contact employees with appropriate tools, training, and resources necessary to provide effective and timely customer service C.2 Product Delivery - The organization shall establish and maintain methods to minimize interference with the customer's normal site operation and service during product delivery and installation. QBS Quality Business Solutions Inc. 92

93 TL 9000 Add-On Requirements For Control of Production and Servicing CONT HS.1 Emergency Service - The organization shall ensure that services and resources are available to support recovery from emergency failures of product in the field throughout its expected life HS.2 The organization shall establish and maintain a documented installation plan. The installation plan shall identify the resources, the information required, the sequence of events and any necessary records HV.1 Operational Changes - Each time a significant change is made in the established operation (e.g., a new operator, new machine, or new technique), a critical examination shall be made of the first unit(s)/service(s) processed after the change. QBS Quality Business Solutions Inc. 93

94 TL 9000 Add-On Requirements For Control of Production and Servicing CONT S.1 The organization shall establish and maintain a documented software patching procedure S.2 Patch Documentation - The organization shall establish and maintain methods to ensure that all documentation required to describe, test, install, and apply a patch has been verified and delivered with the patch S.3 Replication - The organization shall establish and maintain a documented procedure for replication. QBS Quality Business Solutions Inc. 94

95 TL 9000 Add-On Requirements For Control of Production and Servicing CONT V.1 Software Used in Service Delivery - The organization shall establish and maintain a documented procedure for the maintenance and control of software used in service delivery to ensure continued process capability and integrity (e.g. debugging/diagnostics tools, test scripts, etc.) V.2 Tool Changes - The organization shall establish and maintain a documented procedure to ensure that substitutions or changes to tools used in performing the service do not adversely affect the quality of the service. QBS Quality Business Solutions Inc. 95

96 7.5.2 Validation of Processes The organization needs to validate processes when outputs of processes cannot be verified. That is, processes where deficiencies become apparent only after product is in use. Validation process should include: Defined criteria for approval of process Approval of equipment and qualification of personnel Use of specific methods and procedures Records of validation and re-validation required. QBS Quality Business Solutions Inc. 96

97 7.5.3 Identification & Traceability The organization shall identify the product by suitable means throughout production and service operations. This includes: Identifying status of product with respect to monitoring and measurement Control unique identification, when a requirement (e.g. S/N). QBS Quality Business Solutions Inc. 97

98 TL 9000 Add-On Requirements For Identification and Traceability H.1 Traceability for Recall - Field Replaceable Units (FRU) shall be traceable throughout the product life cycle in a way that helps organizations and their customers to identify products being recalled, needing to be replaced, or modified H.2 Traceability of Design Changes - The organization shall define and implement methods necessary to provide traceability of design changes to identifiable manufacturing dates, lots, or serial numbers HS.1 Product Identification - The organization shall establish and maintain a process for the identification of each product and the level of required control. QBS Quality Business Solutions Inc. 98

99 7.5.4 Customer Property The organization shall: Exercise care with customer property Identify, verify, protect and safeguard Report to the customer any lost, damaged, or unsuitable property Records of loss, damage or unsuitability are required. QBS Quality Business Solutions Inc. 99

100 7.5.5 Preservation of product The organization shall preserve the product during internal processing and during delivery to intended destination. This includes identification, handling, packaging, storage and protection. Preservation also applies to constituent parts. QBS Quality Business Solutions Inc. 100

101 TL 9000 Add-On Requirements For Preservation of Product C.1 Protection from Electrostatic Discharge (ESD) Damage - Where applicable, ESD protection shall be employed for components and products susceptible to ESD damage HS.1 Packaging and Labeling Verification - The organization shall establish and maintain methods to ensure that the packaging and labeling of products and components conform to specified requirements. NOTE Packaging and labeling verification is normally performed on products ready to ship and may include marking and labeling (e.g., hazardous material marking, ESD sensitivity, barcoding etc.) QBS Quality Business Solutions Inc. 101

102 TL 9000 Add-On Requirements For Preservation of Product CONT HV.1 Deterioration - Where the possibility of deterioration exists, the organization shall establish and maintain methods to determine when materials that may impact product quality have deteriorated or exceeded their expiration dates, and assess any required subsequent action S.1 Software Virus Protection - The organization shall establish and maintain methods for software virus prevention, detection, and removal from the deliverable product. QBS Quality Business Solutions Inc. 102

103 7.6 Control of Monitoring and Measuring Devices The organization shall identify devices required to measure/monitor the product. Measuring equipment: Shall be calibrated at specified intervals; Be adjusted/re-adjusted as necessary; Be identified as to its calibration status; Be safeguarded from adjustments that would invalidate measurements. Measurement standards must be traceable to international standards. QBS Quality Business Solutions Inc. 103

104 TL 9000 Add-On Requirements For 7.6 Control of Monitoring and Measuring Equipment 7.6.C.1 Equipment Identification - Monitoring and measuring equipment that is either inactive or unsuitable for use shall be visibly identified and not used. All monitoring and measuring equipment that does not require calibration shall be identified. QBS Quality Business Solutions Inc. 104

105 8.1 General The organization shall plan and implement the monitoring, measurement, analysis and improvement processes in order to: Demonstrate conformity of product Ensure conformity of the QMS To continually improve the effectiveness of the QMS. Determine the need for, and use of, applicable methods, including statistical techniques QBS Quality Business Solutions Inc. 105

106 8.2 Measurement and Monitoring Customer satisfaction The organization shall monitor customer perception as to whether customer requirements have been met. QBS Quality Business Solutions Inc. 106

107 TL 9000 Add-On Requirements For Customer Satisfaction C.1 Customer Satisfaction Data - The organization shall establish and maintain a method to collect data directly from customers concerning their satisfaction with provided products. The organization shall also collect customer data on how well the organization meets commitments and its responsiveness to customer feedback and needs. This data shall be analyzed and trended. QBS Quality Business Solutions Inc. 107

108 8.2.2 Internal Audit The organization shall conduct internal audits at planned intervals to determine if: QMS conforms to requirements QMS is effectively implemented and maintained. Planning of the audit program should: Consider status and importance of areas Consider results of previous audits Define audit scope, criteria, frequency, methods Select auditors and conduct audits to ensure objectivity and impartiality. QBS Quality Business Solutions Inc. 108

109 8.2.2 Internal Audit (cont.) There needs to be a documented procedure to address: Responsibility and audit requirements Planning and conduct of audit Recording Results and maintaining records. Take corrective action without undue delay Verify corrective action Report verification results Records of internal audits are required. QBS Quality Business Solutions Inc. 109

110 8.2.3 Monitoring and Measurement of processes The organization shall apply suitable methods of monitoring, and where applicable, measurement of QMS processes to confirm the ability of processes to achieve planned results. Where planned results are not achieved, take correction and corrective action, as appropriate. QBS Quality Business Solutions Inc. 110

111 TL 9000 Add-On Requirements For Monitoring and Measurement of Processes C.1 Process measurements shall be identified, documented, and monitored at appropriate points to ensure continued suitability and promote increased effectiveness of processes. This includes the establishment of appropriate design process measurements. Key process measurements that impact conformity to product requirements should have specific performance targets or control limits established. QBS Quality Business Solutions Inc. 111

112 8.2.4 Monitoring and measurement of product The organization shall monitor and measure product characteristics to verify that requirements for product are met. This includes: Carrying out inspection/tests at appropriate stages of realization in accordance with plans; Maintaining evidence that test criteria have been met; Successfully completing all activities before release and delivery. QBS Quality Business Solutions Inc. 112

113 8.2.4 Monitoring and measurement of product In addition, records of inspection and testing must: indicate the name of the tester/inspector. QBS Quality Business Solutions Inc. 113

114 TL 9000 Add-On Requirements For Monitoring and Measurement of Product H.1 Periodic Retesting - The organization shall establish and maintain a documented procedure that ensures products are periodically retested to assess the product's ability to continue to meet design requirements H.2 Content of Testing - The initial test and periodic retest shall be more extensive than the routine quality tests H.3 Frequency of Testing - The organization shall establish and document the frequency for test and periodic retest. QBS Quality Business Solutions Inc. 114

115 TL 9000 Add-On Requirements For Monitoring and Measurement of Product CONT H.4 Testing of Repair and Return Products - Repair and return products shall be subjected to the appropriate evaluation(s) and/or test(s) to ensure functionality to product specification HV.1 Inspection and Test Documentation - Each inspection or testing activity throughout the product life cycle shall have detailed documentation. Details should include. a) through h). QBS Quality Business Solutions Inc. 115

116 TL 9000 Add-On Requirements For Monitoring and Measurement of Product CONT HV.2 Inspection and Test Records - Inspection or test records shall include a) product identification, b) quantity of product, c) documented procedure(s) followed, d) person(s) performing the test or inspection, e) calibrated equipment used, f) date performed, and g) number, type, and severity of defects found. QBS Quality Business Solutions Inc. 116

117 TL 9000 Add-On Requirements For Monitoring and Measurement of Product CONT S.1 Test Documentation - Software tests shall be conducted per the test plan according to a documented procedure(s). Records of testing shall include a) test results, b) analysis of test results, c) conformity to expected results, and d) problem reporting for nonconforming items. QBS Quality Business Solutions Inc. 117

118 8.3 Control of Nonconforming Product The organization shall identify and control nonconforming product to prevent its unintended use or delivery. There needs to be a documented procedure for controls and responsibilities. Records of nonconforming product are required Corrected product needs to be re-verified before release. QBS Quality Business Solutions Inc. 118

119 8.4 Analysis of Data The organization needs to collect and analyze data on its quality system in order to: Demonstrate suitability and effectiveness of QMS Evaluate areas for continual improvement. Analysis of data should provide information on: Customer satisfaction Conformity to product requirements Characteristics and trends of product, processes, and opportunities for preventive action Suppliers. QBS Quality Business Solutions Inc. 119

120 TL 9000 Add-On Requirements For 8.4 Analysis of Data 8.4.C.1 Trend Analysis of Nonconforming Product - Trend analysis of discrepancies found in nonconforming product shall be performed on a defined, regular basis and results utilized as input for corrective and preventive action. 8.4.HS.1 Field Performance Data - The quality management system shall include the collection and analysis of field performance data which can be used to help identify the cause and frequency of product failure. 8.4.V.1 Service Performance Data - The quality management system shall include the collection and analysis of service performance data, which can be used to identify the cause and frequency of service failure. QBS Quality Business Solutions Inc. 120

121 8.5 Improvement Continual Improvement The organization shall continually improve the effectiveness of the QMS through the use of: Quality policy Quality objectives Audit results Analysis of data Corrective and preventive action Management review QBS Quality Business Solutions Inc. 121

122 TL 9000 Add-On Requirements For Continual Improvement C.1 The organization shall establish and maintain a continual improvement program that includes a focus to improve: customer satisfaction, quality and reliability of the product, and other processes/products/services used within the organization C.2 Employee Participation - The organization shall implement methods for encouraging employee participation in the continual improvement program. QBS Quality Business Solutions Inc. 122

123 8.5.2 Corrective Action The organization shall eliminate causes of nonconformity and prevent recurrence. A documented procedure defining how to: Review nonconformity, including customer complaints Determine the root cause Evaluate the need for action Determine and implement needed action Retain Records of results of action taken Review the effectiveness of action taken. QBS Quality Business Solutions Inc. 123