ISO 9000-4 1993 Guidelines in Plain English

Guidelines for Designing and Managing Product Dependability Programs

ISO 9000-4

Product dependability policy and objectives 

• Define and document your product dependability 
  policy and your product dependability objectives.

  • Define a policy that explains your attitude towards product dependability and which specifies dependability characteristics.

  • List the product dependability objectives
    you want to achieve.

Functions and resources 

• Define functions and provide resources.

  • Define the organizational functions and services that 
    you will need in order to manage and maintain your 
    Product Dependability Program.

  • Ensure that your Product Dependability Program has 
    all the resources it needs to carry out these functions 
    and perform these services.

Dependability requirements and customer needs 

• Product dependability requirements should be defined by researching customer needs and expectations.

  • Therefore market research procedures are needed.

Program review

• Develop Program evaluation procedures.

  • Develop and document procedures that senior managers 
    can use to evaluate the performance of your Product Dependability Program.

  • Develop and document procedures that independent groups 
    can use to review product dependability performance, 
    processes, procedures, tools, tasks, results, and costs.

Program documentation 

• Document your Product Dependability Program.

  • Document the methods and procedures 
    used to define dependability characteristics.

  • Document the methods and procedures 
    used to control dependability characteristics.

  • Document the methods and procedures 
    used to evaluate dependability characteristics.

Dependability measurement

• Identify quantitative and qualitative tools to estimate and analyze the dependability of your products.

  • Ensure that these tools are made available to staff.

  • Ensure that they know how to use these tools.

Information system 

• Set up an information system to track 
  and store product dependability data.

• Use this data to design and redesign your 
  products and to plan your maintenance activities.

Documents
and records 

• Product dependability documents and records should be maintained. These documents and records should include product dependability:

  • Plans 

  • Test data

  • Field data

  • Analyses

  • Predictions

  • Instructions

  • Requirements

• Maintain a master list of program dependability documents 
  and records and make sure that only current authorized 
  versions are in circulation.

Planning 

• Develop a product dependability plan. It should:

  • Explain how you intend to meet product 
    dependability requirements and objectives.

  • Describe the resources you will use to meet 
    your dependability requirements and objectives.

  • Define the steps you will take to meet your 
    dependability requirements and objectives.

Contract review 

• Develop procedures to coordinate and control the review of customer contracts. Your contract review procedures should make sure that:

  • Dependability requirements are defined.

  • Operational expectations are clarified.

  • Maintenance obligations are specified.

  • Acceptance tests are described and explained.

  • Dependability differences, between the original 
    tender and the final contract, have been resolved.

  • Management representatives are appointed to 
    supervise and discuss contracts with customers.

  • Records are kept which describe review decisions.

Dependability requirements 

• Define detailed product dependability requirements.

  • Define product availability requirements.

  • Define product reliability requirements.

  • Define product maintainability requirements.

• Clarify your maintenance support assumptions.

• Before you design products, make sure that product 
  dependability requirements are clarified and that 
  the design will meet these requirements.

Design and maintenance 

• Develop product design and maintenance guidelines to ensure that product dependability requirements are met. These guidelines must:

  • Address product reliability, maintainability, and testability issues.

  • Address the human factors that could affect product dependability.

External products 

• Develop procedures to define dependability
  requirements for products provided by outsiders.

  • Make sure that products provided by subcontractors (suppliers)
    clearly meet your product dependability requirements.

  • Make sure that products provided by your customers
    clearly meet your product dependability requirements.

Analysis and review 

• Evaluate product dependability. Analyze, predict, and review 
  the dependability of your products. Consider using the following kinds of tools and techniques:

  • Human factors analysis

  • Fault tree analysis

  • Tradeoff analysis

  • Stress analysis

  • Risk analysis

Verification and validation 

• Verify and validate product dependability. Develop procedures to verify and validate product dependability requirements. Consider using the following kinds of:

  • Planning procedures

    • Verification planning

    • Validation planning

    • Test planning

  • Testing procedures

    • Reliability tests

    • Production tests

    • Acceptance tests

    • Dependability tests

Life-cycle costs 

• Calculate costs. Develop procedures to calculate 
  and analyze product life-cycle costs.

Customer support 

• Support your products. Make sure your customers know how to:

  • Operate your products.

  • Maintain your products.

    • In order to ensure that your customers properly maintain
      your products, make sure they know what kinds of:

      • Spare parts should be used.

      • Test equipment should be used.

      • Maintenance tools should be applied.

      • Skills their maintenance people should have.

Dependability improvement 

• Develop procedures to improve the dependability of your products. Your procedures should ensure that dependability improvement opportunities are identified and exploited. Your procedures should try to:

  • Improve product reliability

  • Improve product availability

  • Improve product maintainability

• Develop procedures to control the product dependability improvement process. Your procedures should ensure that:

  • Changes are reviewed.

  • Previous analyses are repeated.

  • Prior predictions are reconsidered.

  • Old data and documents are re-examined.

Dependability feedback 

• Develop a product dependability feedback system.

  • Develop procedures to collect product dependability data during:

    • Testing

    • Manufacturing

    • Field use

  • Develop procedures to handle, store, 
    and analyze product dependability data.

  • Develop procedures that customers can use to collect product dependability data and to report their experience back to you.

ISO 9000-4

Disclaimer and Limitation of Liability

The publisher and authors have used their best efforts in designing and developing this electronic publication. We make no representation or warranties with respect to accuracy or completeness of the contents of this publication and specifically disclaim any implied warranties or merchantability or fitness for any particular purpose and shall in no event be liable for any loss of profit or any other commercial damage, including but not limited to special, incidental, consequential, or other damages.

Legal Restrictions on the Use of this Page

Thank you for visiting this page. You are, of course, welcome to view our material as often as you wish, free of charge. And as long as you keep intact all copyright notices, you are also welcome to print or make one copy of this page for your own personal, noncommercial, home use.  But, you are not legally authorized to print or produce additional copies.  If you need to make more than one copy, please contact our Order Desk about purchasing a Site License.