Understanding (and Untangling) Verification and Understanding (and Untangling) Verification and...

Understanding (and Untangling)Verification and Validation

Requirements

ISO 9001 vs. CMMI-Dev 1.2

www.platinumregistration.com (303) 639-9001 info@platinumregistration.com 2

Objectives

• Discuss design verification vs. validation

• Get a taste of both ISO 9001 and CMMI

• Perform a quick comparison of the twostandards (with a limited scope)

Dissimilar Scope and Focus

• CMMI for Development

• ISO 9001 - Generic

• CMMI - “Improving Processes for BetterProducts”

• 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 workproduct properly reflects the specifiedrequirements.”

• “Validation demonstrates that the product, asprovided, 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 designspecification,- 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 orapplication 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 DevelopmentVerification

– 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 DevelopmentValidation

– 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 ofthe specific goals of the process area by transformingidentifiable input work products to produce identifiableoutput work products.

• GP 1.1 Perform Specific Practices

– Perform the specific practices of the process area todevelop work products and provide services toachieve the specific goals of the process area.

• GG 2 Institutionalize a Managed Process

– The process is institutionalized as a managedprocess.

– GP 2.1 Establish an Organizational Policy

• Establish and maintain an organizational policy forplanning and performing the process.

– GP 2.2 Plan the Process

• Establish and maintain the plan for performing theprocess.

Generic Goals & Practices (2) Cont.

– GP 2.3 Provide Resources• Provide adequate resources for performing the

process, developing the work products, andproviding the services of the process.

– GP 2.4 Assign Responsibility• Assign responsibility and authority for performing

the process, developing the work products, andproviding 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 correctiveaction.

– GP 2.9 Objectively Evaluate Adherence

• Objectively evaluate adherence of the processagainst its process description, standards, andprocedures, and address noncompliance.

– GP 2.10 Review Status with Higher LevelManagement

• Review the activities, status, and results of theprocess with higher level management and resolveissues.

• 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 andperforming the process to support the future use andimprovement of the organization’s processes and processassets.

ISO 9001 Verification

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

2. …to ensure that the design and developmentoutputs have met the design and developmentinput requirements.

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

CMMI Verification (SG 1)

• SG 1 Prepare for Verification, “Preparation forverification is conducted.”– SP 1.1 Select Work Products for Verification, “Select

the work products to be verified and the verificationmethods that will be used for each.”

– SP 1.2 Establish the Verification Environment,“Establish and maintain the environment needed tosupport verification.”

– SP 1.3 Establish Verification Procedures and Criteria,“Establish and maintain verification procedures andcriteria for the selected work products.”

• SG 2 Perform Peer Reviews, “Peer reviews areperformed on selected work products.”

– SP 2.1 Prepare for Peer Reviews, “Prepare for peerreviews of selected work products.”

– SP 2.2 Conduct Peer Reviews, “Conduct peerreviews on selected work products and identify issuesresulting from the peer review.”

– SP 2.3 Analyze Peer Review Data, “Analyze dataabout preparation, conduct, and results of the peerreviews.”

• SG 3 Verify Selected Work Products,“Selected work products are verifiedagainst their specified requirements.”

– SP 3.1 Perform Verification, “Performverification on the selected work products.”

– SP 3.2 Analyze Verification Results, “Analyzethe results of all verification activities.”

ISO 9001 Validation

1. Design and development validation shall be performedin accordance with planned arrangements (see 7.3.1)…

2. …to ensure that the resulting product is capable ofmeeting the requirements for the specified applicationor intended use, where known.

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

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

CMMI Validation (SG 1)

• SG 1 Prepare for Validation, “Preparation forValidation is Conducted.”– SP 1.1 Select Products for Validation, “Select

products and product components to be validated andthe validation methods that will be used for each.”

– SP 1.2 Establish the Validation Environment,“Establish and maintain the environment needed tosupport validation.”

– SP 1.3 Establish Validation Procedures and Criteria,“Establish and maintain procedures and criteria forvalidation.”

CMMI Validation (SG 2)

• SG 2 Validate Product or Product Components,“The product or product components arevalidated to ensure that they are suitable for usein their intended operating environment.”

– SP 2.1 Perform Validation, “Perform validation on theselected products and product components.”

– SP 2.2 Analyze Validation Results, “Analyze theresults of the validation activities.”

How Do You Select?

• Do you need to select?

• Worry about processes first, the standardsecond

• Improve businesses first, satisfy thestandard second

• What does the customer want?

More at www.pr-inc.com

Closing Credits

Matt Leiphart

Platinum Registration

303 639-9001

matt@platinumregistration.com

www.platinumregistration.com

Understanding (and Untangling) Verification and Understanding (and Untangling) Verification and...

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