Understanding and Untangling Verification and Validation Requirements

1
Understanding (and Untangling) Verification and
Validation Requirements

• ISO 9001 vs. CMMI-Dev 1.2

2
Objectives

• Discuss design verification vs. validation
• Get a taste of both ISO 9001 and CMMI
• Perform a quick comparison of the two standards
  (with a limited scope)

3
Dissimilar Scope and Focus

• CMMI for Development
• ISO 9001 - Generic
• CMMI - Improving Processes for Better Products
• ISO 9001 - Quality management systems
  Requirements

4
Validation vs. Verification

• CMMI Says It Best
• Verification You built (designed) it right
• Validation You built (designed) the right
  thing.
• verification addresses whether the work product
  properly reflects the specified requirements.
• Validation demonstrates that the product, as
  provided, will fulfill its intended use
• (CMMI-Dev 1.2, pp 483)

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How ISO 9000 Explains It

• 3.8.4 Verification - Confirmation, through the
  provision of objective evidence (3.8.1), that
  specified requirements (3.1.2) have been
  fulfilled.
• NOTE 1 The term verified is used to designate
  the corresponding status.
• NOTE 2 Confirmation can comprise activities such
  as
• - performing alternative calculations,
• - comparing a new design specification (3.7.3)
  with a similar proven design specification,
• - undertaking tests (3.8.3) and demonstrations,
  and
• - reviewing documents prior to issue.
• 3.8.5 Validation Confirmation, through the
  provision of objective evidence (3.8.1), that the
  requirements (3.1.2) for a specific intended use
  or application have been fulfilled.
• NOTE 1 The term validated is used to designate
  the corresponding status.
• NOTE 2 The use conditions for validation can be
  real or simulated.

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Source of Requirements

• Verification
• ISO 9001 section 7.3.5 Design and Development
  Verification
• CMMI Part Two, Verification (VER)
• SG 1-3, SP 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2
• Validation
• ISO 9001 section 7.3.6 Design and Development
  Validation
• CMMI Part Two, Validation (VAL)
• SG 1-2, SP 1.1, 1.2, 1.3, 2.1, 2.2

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Referenced Requirements

• ISO 9001
• 7.3.1 Design and Development Planning
• 4.2.4 Control of Records
• CMMI
• Generic Goals
• Generic Practices
• (Limited to Levels 1-3 Capability/Maturity)

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Generic Goals Practices (1)

• GG 1 Achieve Specific Goals
• The process supports and enables achievement of
  the specific goals of the process area by
  transforming identifiable input work products to
  produce identifiable output work products.
• GP 1.1 Perform Specific Practices
• Perform the specific practices of the process
  area to develop work products and provide
  services to achieve the specific goals of the
  process area.

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Generic Goals Practices (2)

• GG 2 Institutionalize a Managed Process
• The process is institutionalized as a managed
  process.
• GP 2.1 Establish an Organizational Policy
• Establish and maintain an organizational policy
  for planning and performing the process.
• GP 2.2 Plan the Process
• Establish and maintain the plan for performing
  the process.

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Generic Goals Practices (2) Cont.

• GP 2.3 Provide Resources
• Provide adequate resources for performing the
  process, developing the work products, and
  providing the services of the process.
• GP 2.4 Assign Responsibility
• Assign responsibility and authority for
  performing the process, developing the work
  products, and providing the services of the
  process.
• GP 2.5 Train People
• Train the people performing or supporting the
  process as needed.

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Generic Goals Practices (2) Cont.

• GP 2.6 Manage Configurations
• Place designated work products of the process
  under appropriate levels of control.
• GP 2.7 Identify and Involve Relevant Stakeholders
• Identify and involve the relevant stakeholders of
  the process as planned.
• GP 2.8 Monitor and Control the Process
• Monitor and control the process against the plan
  for performing the process and take appropriate
  corrective action.

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Generic Goals Practices (2) Cont.

• GP 2.9 Objectively Evaluate Adherence
• Objectively evaluate adherence of the process
  against its process description, standards, and
  procedures, and address noncompliance.
• GP 2.10 Review Status with Higher Level
  Management
• Review the activities, status, and results of the
  process with higher level management and resolve
  issues.

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Generic Goals Practices (3)

• GG 3 Institutionalize a Defined Process
• The process is institutionalized as a defined
  process.
• GP 3.1 Establish a Defined Process
• Establish and maintain the description of a
  defined process.
• GP 3.2 Collect Improvement Information
• Collect work products, measures, measurement
  results, and improvement information derived from
  planning and performing the process to support
  the future use and improvement of the
  organizations processes and process assets.

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ISO 9001 Verification

• Verification shall be performed in accordance
  with planned arrangements (see 7.3.1)
• to ensure that the design and development
  outputs have met the design and development input
  requirements.
• Records of the results of the verification and
  any necessary actions shall be maintained (see
  4.2.4).

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CMMI Verification (SG 1)

• SG 1 Prepare for Verification, Preparation for
  verification is conducted.
• SP 1.1 Select Work Products for Verification,
  Select the work products to be verified and the
  verification methods that will be used for each.
• SP 1.2 Establish the Verification Environment,
  Establish and maintain the environment needed to
  support verification.
• SP 1.3 Establish Verification Procedures and
  Criteria, Establish and maintain verification
  procedures and criteria for the selected work
  products.

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CMMI Verification (SG 2)

• SG 2 Perform Peer Reviews, Peer reviews are
  performed on selected work products.
• SP 2.1 Prepare for Peer Reviews, Prepare for
  peer reviews of selected work products.
• SP 2.2 Conduct Peer Reviews, Conduct peer
  reviews on selected work products and identify
  issues resulting from the peer review.
• SP 2.3 Analyze Peer Review Data, Analyze data
  about preparation, conduct, and results of the
  peer reviews.

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CMMI Verification (SG 3)

• SG 3 Verify Selected Work Products, Selected
  work products are verified against their
  specified requirements.
• SP 3.1 Perform Verification, Perform
  verification on the selected work products.
• SP 3.2 Analyze Verification Results, Analyze the
  results of all verification activities.

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ISO 9001 Validation

• Design and development validation shall be
  performed in accordance with planned arrangements
  (see 7.3.1)
• to ensure that the resulting product is capable
  of meeting the requirements for the specified
  application or intended use, where known.
• Wherever practicable, validation shall be
  completed prior to the delivery or implementation
  of the product.
• Records of the results of validation and any
  necessary actions shall be maintained (see
  4.2.4).

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CMMI Validation (SG 1)

• SG 1 Prepare for Validation, Preparation for
  Validation is Conducted.
• SP 1.1 Select Products for Validation, Select
  products and product components to be validated
  and the validation methods that will be used for
  each.
• SP 1.2 Establish the Validation Environment,
  Establish and maintain the environment needed to
  support validation.
• SP 1.3 Establish Validation Procedures and
  Criteria, Establish and maintain procedures and
  criteria for validation.

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CMMI Validation (SG 2)

• SG 2 Validate Product or Product Components, The
  product or product components are validated to
  ensure that they are suitable for use in their
  intended operating environment.
• SP 2.1 Perform Validation, Perform validation on
  the selected products and product components.
• SP 2.2 Analyze Validation Results, Analyze the
  results of the validation activities.

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How Do You Select?

• Do you need to select?
• Worry about processes first, the standard second
• Improve businesses first, satisfy the standard
  second
• What does the customer want?

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Closing Credits

• Matt Leiphart
• Platinum Registration
• 303 639-9001
• matt_at_platinumregistration.com
• www.platinumregistration.com