Systematic process improvement using ISO 9001:2000 and CMMI

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254 Appraisal/Registration readiness for a formal audit. The preassessment reviews the quality manual, procedures, and implementation of those procedures. Gaps in documentation are noted and the date for the formal audit is determined based on the severity and magnitude of the detected gaps. During the documentation review, the assessor reviews the organization’s quality manual and the procedures required by the standard. Findings are documented and reported. The documents to be reviewed fall into three categories: organizational (typically plans), implementation (such as procedures, work instructions, and process descriptions), and control (such as measurements, reports, and checklists). Documentation deficiencies have to be corrected before the organization can be recommended for registration. If documentation was initially reviewed during the preassessment, the auditor may choose to review only revised documentation during the assessment to ensure that recommended changes were implemented correctly. An example of the review form is shown in Table 8.5. On the first day of the assessment, the auditor typically presents an overview of the assessment process. The assessment follows the ISO 19011:2002 standard [8] and, in some instances, additional procedures that were developed by the registrars themselves. The auditor then conducts indepth reviews of the organization’s procedures and evaluates their implementation for conformance with the ISO 9001:2000 standard. In addition to the documentation review, the assessment will include interviews and observations to determine the extent of the implementation of the standard. Interview questions are typically derived from the requirements of the ISO 9001 standard. If there is more than one auditor, specific areas of activity may be examined in parallel. Through reviews, interviews, and observations, the auditors examine objective evidence of process conformance to the organizational documentation and conformance with the standard. Most assessors develop tools to facilitate data collection and analysis. For example, Tables 8.4 and 8.5 can be combined into one spreadsheet that will indicate the documentation collected, documentation reviewed, the staff to be interviewed, and the interview responses. Table 8.5 Example of Typical Assessment Records Clause Description Typical Evidence Reference Comments 6.2.2 Competency, • Records of course/ awareness, seminar completion and training • Course attendance lists • Mentoring/OJT records • Résumés/waivers
8.2 ISO 9001:2000 registration process 255 Several excellent references provide guidelines for auditing [9–11]. A very interesting approach to auditing is described in [12]. The author provides a detailed framework for auditing that emphasizes a business perspective rather than following the ISO requirements structure. The framework consists of five ‘‘audit trails’’ each covering a path through the complete ISO standard using threads that are designed to examine related ISO requirements. It outlines what to audit and the evidence required for showing that the ISO requirements were satisfied. These five audit trails are defined next: A—Business planning and management review: Addresses the relationships between customer requirements, quality objectives, quality policy, quality planning, provision of resources, management reviews, customer satisfaction, and internal audits B—Process monitoring and improvement: Addresses the relationships between general requirements for process improvement, monitoring and measurement of processes, analysis of data, improvement, and the need for corrective and preventive actions. C—New product development: Addresses the customer-related processes, such as requirement definition and review, planning of the product realization, design and development including their reviews, verification and validation, and general measurement, analysis and improvement activities. D—Provision: Addresses the control of production and service provision, purchasing, identification and traceability, control of nonconforming product, analysis of data, and improvement. E—Administration and resources: Addresses a set of tasks that support activities in all other trails, such as responsibility, authority and communication, management representative, internal communication, documentation requirements, human resources, infrastructure, and work environment. Those five audit trails are shown in Table 8.6. For example, the New Product Development audit trail (Trail C) covers the requirements of these ISO 9001 sections: 7.1 Planning of product realization; 7.2 Customer-related processes; 7.3 Design and development; 8.1 General (measurement, analysis, and improvement).
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Systematic Process Improvement Usin
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Systematic Process Improvement Usin
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To our wives, Mirta and Susan, and
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Contents Foreword . . . . . . . . .
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Contents ix 5.6 Summary of ISO requ
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Foreword As we began the work in 19
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Foreword xiii tion’s investment i
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xvi Preface Audience for this book
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xviii Preface organizations have pu
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CHAPTER 1 Contents 1.1 Role of fram
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Introduction 3 Figure 1.1 Framework
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1.2 Process improvement approaches
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1.3 Synergy 7 Figure 1.2 Systematic
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1.3 Synergy 9 • Educated and well
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1.3 Synergy 11 References [1] Shear
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14 Process Improvement • Identifi
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16 Process Improvement life-cycle m
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18 Process Improvement Although the
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20 Process Improvement Figure 2.2 I
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22 Process Improvement To help reso
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24 Process Improvement improvement
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26 Process Improvement 2. Analyze r
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28 Process Improvement Table 2.1 Im
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CHAPTER 3 Contents 3.1 Relationship
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3.1 Relationships between framework
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3.3 CMM ® for software 35 by its u
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3.3 CMM ® for software 37 Table 3.
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3.3 CMM ® for software 39 Figure 3
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3.3 CMM ® for software 41 Figure 3
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3.4 ISO TR 15504 43 • Defect Prev
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3.4 ISO TR 15504 45 Table 3.5 ISO T
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3.5 EIA/IS-731 47 Table 3.7 Managem
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3.5 EIA/IS-731 49 Table 3.8 EIA/IS-
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3.5 EIA/IS-731 51 Table 3.9 EIA/IS-
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3.6 FAA-iCMM ® 53 of the model (su
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3.6 FAA-iCMM ® 55 Table 3.12 Capab
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3.7 Summary 57 Table 3.13 Maturity
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CHAPTER 4 Contents 4.1 ISO 9001:200
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4.1 ISO 9001:2000 61 the current st
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4.1 ISO 9001:2000 63 Principle 4: p
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4.1 ISO 9001:2000 65 agement level
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4.1 ISO 9001:2000 67 for understand
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4.1 ISO 9001:2000 69 • Which tool
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4.1 ISO 9001:2000 71 responsibility
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4.1 ISO 9001:2000 73 It is often sa
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4.1 ISO 9001:2000 75 covery of erro
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4.1 ISO 9001:2000 77 measured, and
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4.2 CMMI ® 79 resistance to this p
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4.2 CMMI ® 81 and staged represent
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4.2 CMMI ® 83 Figure 4.4 Continuou
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4.2 CMMI ® 85 Table 4.6 Category C
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4.2 CMMI ® 87 Table 4.7 Generic Go
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4.2 CMMI ® 89 Table 4.8 Generic Go
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4.2 CMMI ® 91 Why is this importan
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4.2 CMMI ® 97 • Identifying and
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4.2 CMMI ® 99 uous representation
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4.2 CMMI ® 101 SG 2 SP 2.1-1 SP 2.
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4.2 CMMI ® 103 Interfaces between
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4.2 CMMI ® 105 SP 2.6-1 SP 2.7-1 S
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4.2 CMMI ® 107 SG 1 SP 1.1-1 SP 1.
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4.2 CMMI ® 109 Why is this importa
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4.2 CMMI ® 111 from business objec
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4.2 CMMI ® 113 SG 1 SP 1.1-1 SP 1.
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4.2 CMMI ® 115 SG 3 SP 3.1-1 SP 3.
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4.2 CMMI ® 117 Why is this importa
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4.2 CMMI ® 119 [5] Quality managem
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122 ISO 9001:2000 and CMMI ® Syner
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154 Transitioning from Legacy Stand
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Page 271 and 272: 8.1 SCAMPI SM 249 relevant stakehol
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Page 275: 8.2 ISO 9001:2000 registration proc
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Page 283 and 284: 8.5 Summary 261 in Chapter 7, achie
Page 285 and 286: CHAPTER 9 Contents Document Mapping
Page 287 and 288: 9.1 Mapping: ISO 9001:2000 to the C
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Page 291 and 292: 9.2 Inverse mapping: CMMI ® to ISO
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Page 306 and 307: 284 Acronyms FAM FAA-iCMM ® Apprai
Page 308 and 309: 286 Acronyms SCAMPI SM Standard CMM
Page 311 and 312: Index A audience, this book, xv-xvi
Page 313 and 314: Index 291 design and development, 1
Page 315 and 316: Index 293 technical solution (TS),
Page 317 and 318: Index 295 ISO 9001:2000 transition,
Page 319 and 320: Index 297 organizational innovation
Page 321 and 322: Index 299 S supplier agreement mana
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