Understanding (and Untangling) Verification and Validation Requirements ISO 9001 vs. CMMI-Dev 1.2.

Understanding (and Untangling) Verification and Validation

RequirementsISO 9001 vs. CMMI-Dev 1.2

www.platinumregistration.com (303) 639-9001 [email protected] 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)


Dissimilar Scope and Focus

• CMMI for Development

• ISO 9001 - Generic

• CMMI - “Improving Processes for Better Products”

• ISO 9001 - “Quality management systems – Requirements


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)


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.”


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


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)


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.



• 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.


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.



– 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.



– 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.



• 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 organization’s processes and process assets.


ISO 9001 Verification

1. Verification shall be performed in accordance with planned arrangements (see 7.3.1)…

2. …to ensure that the design and development outputs have met the design and development input requirements.

3. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).


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.”


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.”


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.”


ISO 9001 Validation1. Design and development validation shall be performed

in accordance with planned arrangements (see 7.3.1)…2. …to ensure that the resulting product is capable of

meeting the requirements for the specified application or intended use, where known.

3. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product.

4. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).


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.”


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.”


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?


More at www.pr-inc.com


Closing Credits

Matt Leiphart

Platinum Registration

303 639-9001

[email protected]

www.platinumregistration.com

Understanding (and Untangling) Verification and Validation Requirements ISO 9001 vs. CMMI-Dev 1.2.

Documents

Transcript of Understanding (and Untangling) Verification and Validation Requirements ISO 9001 vs. CMMI-Dev 1.2.