Quality systems must balance conflicting needs

• Your quality system must balance two needs:

  • Your customers' need to have quality  products at a reasonable price.                         

  • Your company's need to make quality  products at a reasonable cost.                 

• When you sell products to customers consider that:

  • Both your customers and you wish to benefit.

    • Your customers must purchase products  that meet their needs and expectations.

    • Your organization must sell products at a price  that allows it to achieve its financial objectives.

• Both your customers and you must control costs.

  • Your customers wish to minimize their purchase, operating, maintenance repair,  and disposal costs.                                 

  • Your organization wishes to minimize its redesign, repair, replacement, reprocessing, production, storage, handling, servicing, and marketing costs.                                     

• Both your customers and you must control risk.

  • Your customers wish to minimize the health, safety, environmental, operational, and financial risks associated with using  your products.                                         

  • Your organization wishes to minimize  the legal, ethical, and financial risks that  faulty products can generate.                 

Senior managers must make a commitment to quality 

• Your senior managers must demonstrate  a continuous commitment to quality.                       

• Your senior managers must define and document:

  • Quality policy.

  • Quality objectives.

  • Quality responsibilities.

• Your senior managers must ensure that your quality policy is understood and applied throughout your organization.

• Your senior managers must ensure that your quality objectives are understood and achieved throughout your organization.

• Your senior managers must ensure that your quality responsibilities are understood and implemented  throughout your organization.                                   

Senior managers must develop a quality system 

• Your senior managers must develop and  implement a quality system in order to:

  • Apply your quality policy.

  • Achieve your quality objectives.

  • Implement your quality responsibilities.

• Your quality system should be able to prove that:

  • Customer needs are being met.

  • Societal obligations are being satisfied.

  • Environmental concerns are being addressed.

• You should be able to prove that your quality  system is understood and implemented.                  

• You should be able to prove that your quality   system is effective and well maintained.

• Your quality system must monitor and control every aspect  of quality. Any activity, function, or process that influences  quality must be monitored and controlled.

  • Your quality system should prevent quality problems. 

  • Your quality system should ensure that quality  problems are routinely solved when they do occur.

Your quality system should control product quality 

• Your quality system should control the quality of your product during every phase of its lifecycle. These phases can include:

  • Market research and product development. 

  • Process research, planning, and development. 

  • Purchasing, production, packaging, and storage. 

  • Marketing, sales, distribution, and delivery. 

  • Product installation, service, and support. 

  • Product disposal or recycling.

Develop an organizational structure to control your quality system 

• Define the organizational structure that you will need  in order to manage and control your quality system.

  • Define and document all quality system activities.

  • Define and document quality system responsibilities.

  • Specify who is responsible for each quality activity.

  • Grant the authority to carry out each responsibility.

  • Clarify the patterns of interaction and communication  that affect quality.                                       

Senior managers must provide all quality system resources 

• Identify and provide the resources that people need in order to implement and maintain your quality system. Make sure that they can:                                                

  • Apply your quality policy.

  • Achieve your quality objectives.

  • Perform quality responsibilities.

• Make sure that people have the following  kinds of quality system resources:                             

  • Skills and knowledge.

  • Tools and equipment.

  • Software and hardware.

  • Facilities and supplies.

  • Data and information.

Develop procedures to control your quality system 

• Develop, document, and implement procedures to:

  • Apply your quality policy.

  • Achieve your quality objectives.

  • Perform your quality responsibilities.

• Quality system procedures should:

  • Define the quality activities that must be performed.

  • Explain how quality activities should be performed.

Document your quality system 

• Document every aspect of your quality system. Your quality system documentation should include:

  • Policies

  • Procedures

  • Manuals

• Document your quality system using a quality manual.

  • Your quality manual should be used to guide  the implementation of your quality system. 

  • Your quality manual should be used to control  the maintenance of your quality system.

  • Your quality manual must also include a procedure  that controls how the manual will be revised. 

  • Your quality procedures should support,  and be tied into, your quality manual.

Develop
quality 
plans

• A quality plan should be developed for every product,  process, project, or contract. It should define the:

  • Quality objectives that must be achieved. 

  • Practices, processes, procedures, programs, methods, resources, and equipment that will be used to achieve these objectives.                               

• Specifically, quality plans should define the:

  • Practices and processes you intend to use. 

  • Responsibilities that will be allocated. 

  • Procedures that you intend to follow. 

  • Resources that you will need. 

  • Internal audit programs that you will use.

  • Inspections and tests that you will carry out.

  • Methods that you will use to measure success. 

  • Steps that will be taken to modify your plan.

Perform
internal 
quality
audits 

• Regular internal audits should be carried out to ensure that your quality system is implemented and to evaluate its effectiveness.  Your internal quality audit program should clarify:

  • What should be audited.

  • Who should carry out the audits. 

  • What audit procedures should be used.

  • What audit reports should be prepared.

  • How corrective actions should be taken.

  • How corrective measures will be evaluated.

  • How audits should be documented.

  • What audit records should be kept. 

• Your audits should examine:

  • Quality system elements.

  • Procedures and processes. 

  • Tools and equipment.

  • Policies and programs.

  • Products and services. 

  • Documents, reports, and records.

  • Personnel activities and practices.

  • Organizational structure and resources.

Perform management reviews 

• Your senior managers should perform quality system reviews.  These reviews should be planned and performed on a regular  basis. They should:                              

  • Study the results of your internal audits.

  • Evaluate your quality policy and objectives.

    • Evaluate how well your policy is being applied.

    • Evaluate how well objectives are being achieved.

  • Review and evaluate the activities that support  your quality policy and objectives.                             

  • Determine whether your quality system should be updated response to changes in technologies, quality concepts,  corporate strategies, or the business environment.

Encourage continuous
improvement

• Your quality system should create an environment  that supports continuous quality improvement.

  • An environment of continuous quality improvement is one that encourages everyone to improve the efficiency and effectiveness of all activities and processes for the benefit of both the organization and its customers. 

  • An environment of continuous improvement:

    • Encourages a supportive management style. 

    • Promotes values that support improvement. 

    • Expects people to set quality improvement goals.

    • Shows people how to make quality improvements.

    • Supports teamwork and good communication. 

    • Recognizes achievements and contributions. 

Measure the financial effectiveness of your quality system

• Measure the financial effectiveness of your quality system.  Consider using one of the following methods:

  • The quality-cost approach.

  • The process-cost approach. 

  • The quality-loss approach. 

Quality-cost approach

• The quality-cost approach divides costs as follows:

  • Investments, which are divided into:

    • Prevention costs. This is money spent trying  to prevent and avoid quality system problems,  faults, failures, and nonconformities. 

    • Appraisal costs. This is money spent on testing  and inspection, as well as quality system reviews, evaluations, and audits.

  • Losses, which are divided into:

    • Internal failures. This is money spent dealing with products, which fail to meet quality requirements, before they are sold.                         

    • External failures. This is money spent dealing with  problematic products after they've been sold.

Process-cost approach

• The process-cost approach selects a process, and then  figures out what it costs to serve the needs of its customers.  It divides costs as follows:                                   

  • The cost of conformity. This adds up all the money spent ensuring that the process continues to work properly. 

  • The cost of nonconformity. This adds up all the money that must be spent because the process fails to work properly.

Quality-loss approach 

• The quality-loss approach focuses on losses that are  caused by poor quality. It divides losses as follows:

  • Tangible losses. These are losses that result  from rework, repair, warranty work, and so on.

  • Intangible losses. These are losses due to lost  opportunities, systemic inefficiencies, and so on.

Prepare
financial
quality
reports 

• Financial quality reports should be prepared and  submitted to senior management. They should:

  • Discuss the effectiveness of your quality system. 

  • Identify quality system weaknesses and problems. 

  • Formulate quality and cost objectives.

Set up
a market research
system 

• Before you develop a product, do market research. 

  • Ask your marketing people to find out:

    • How many customers need the product. 

    • What grade of product customers want. 

    • What price customers are prepared to pay.

    • What customer needs and expectations are.

  • Ask your marketing people to ensure that everyone:

    • Understands what customers need. 

    • Agrees that you can meet customer needs. 

  • Ask your marketing people to specify customer  requirements. Ask them to specify:

    • Performance or functional requirements. 

    • Aesthetic or sensory requirements. 

    • Installation or layout requirements. 

    • Packaging and storage requirements. 

    • Quality assurance and verification requirements.

• Ask your marketing people to set up a customer feedback system in order to monitor the experience customers have  with your products. This will help you to make market  oriented improvements.                                          

Prepare
product
design
plans 

• Prepare design plans. Make sure that your design  manager prepares a design plan for each product.  Make sure that this plan:                           

  • Describes what tasks and activities must be  performed and who will be responsible for  performing each task and activity. 

  • Defines the product development process that will be followed including the hold-points that dictate when prototypes will be evaluated before the development process is allowed to continue.                         

Control your design process 

• Control your product design process. Make sure that your  design team identifies those special product characteristics that constitute the quality of the product. These may include characteristics or qualities such as:

  • Dependability

  • Serviceability

  • Disposability

  • Suitability

  • Longevity

• Control your design team. Make sure that they:

  • Translate customer needs into specifications.

  • Prove that the specified product can be made  at a cost that ensures a reasonable profit. 

  • Provide the technical data that other staff members  will need to purchase materials, to produce the product,  and to verify its quality.                               

  • Verify design outputs by means of calculations  and the testing of models and prototypes.

  • Validate your designs by evaluating product performance, durability, and dependability, and by determining whether  your design features will meet customer needs.

  • Confirm that your designs conform to all safety,  environmental, and other regulations.

Control your testing and measurement process 

• Explain how products and processes will be evaluated.

  • Explain how your products and processes will be  evaluated and accepted during the design phase.

    • Specify product testing and measurement  methods, techniques, tools, and equipment.

    • Specify process testing and measurement  methods, techniques, tools, and equipment.

  • Explain how your products and processes will be  evaluated and accepted during the production phase.

    • Specify product testing and measurement  methods, techniques, tools, and equipment.

    • Specify process testing and measurement  methods, techniques, tools, and equipment.

Prove that your designs meet requirements 

• Review and verify your product designs in order to identify  and prevent problems. Carry out design reviews in order to:

  • Prove that your product will meet all customer  needs, expectations, and requirements.

  • Prove that your product will perform properly  under all real world operating conditions.

  • Prove that your product will be durable and  dependable in all operational situations.

  • Prove that your product will meet all  aesthetic and sensory requirements.                

  • Prove that your product will comply with  all relevant health and safety regulations.

  • Prove that your product will comply with  all relevant environmental regulations.          

  • Prove that your product will comply with all  relevant national and international standards.

  • Prove that your product will be properly  identified, labeled, and tracked.                   

  • Prove that your product will be properly  packaged, handled, and stored.                        

  • Prove that standard parts can be  used to manufacture your product.                       

  • Prove that your product can be safely handled  during storage and under all operating conditions.

  • Prove that you can, in fact, manufacture  the product you have designed.                          

  • Prove that you can test, measure, and  inspect the product you have designed.           

  • Prove that all materials, supplies, components,  and subassemblies have been specified.

  • Prove that all materials, supplies, components,  and subassemblies will be available.               

  • Prove that all subcontractors and suppliers have  been identified and will be available when needed.

  • Prove that all design changes have been reviewed,  authorized, implemented, and well documented.

  • Prove that all design reviews and evaluations  have been approved and well documented.

  • Prove that final design documents have  been created, reviewed, and approved.

Use appropriate design review methods 

• Review your designs in the following way:

  • Compare your designs with other similar designs.

  • Compare your designs with technical specifications.

  • Compare your designs with product specifications.

  • Test, inspect, or demonstrate models.

  • Test, inspect, or demonstrate prototypes.

  • Test, inspect, or demonstrate production samples.

  • Perform risk analyses.

  • Perform fault tree analyses.

  • Perform failure mode and effect analyses.

  • Perform calculations to verify original calculations.

  • Perform independent reviews, tests, and calculations.

Review and verify product qualities 

• Review and verify the following types of                            product design characteristics (qualities):

  • Dependability

  • Reliability

  • Durability

  • Usability

  • Availability

  • Serviceability

  • Maintainability

  • Upgradability

  • Transportability

  • Installability

  • Storability

  • Securability

  • Preservability

  • Identifiability

  • Traceability

  • Disposability

Carry out market readiness review 

• Carry out a market readiness review before you begin  full scale production. This review should confirm that:

  • Distribution, service, and field people are ready.

  • Installation, operation, and repair manuals are ready.

  • Product tests and production runs were successful.

  • Spare parts inventory levels are adequate.

Control design changes 

• Develop procedures to control changes in product design.  These procedures should make sure that you:

  • Authorize changes in product design. 

  • Verify that authorized changes were implemented.

  • Control the release of documents that define changes. 

  • Manage the use of documents that define changes.

  • Make emergency design changes, when necessary.

  • Authorize the removal of obsolete documents.

  • Remove obsolete drawings and specifications.

  • Verify that obsolete documents are removed. 

Re-evaluate your designs 

• Perform regular design re-evaluations to ensure that  designs are still valid. Re-evaluations should study:

  • Customer feedback

  • Field experiences

  • New technologies

  • New trends

  • Specifications

  • Process modifications

  • Production experiences

Develop a purchasing system 

• Develop and document a quality purchasing system.  Your purchasing system should control:

  • Purchasing documents

  • Subcontractor selection

  • Purchase quality

  • Verification methods

  • Dispute settlement

  • Product receiving

  • Purchasing records.

Control your purchasing documents 

• Develop procedures to control the preparation and use of purchasing documents (specifications, drawings, purchase orders etc.).                         

  • Make sure that your purchasing requirements  are clearly and completely defined.

  • Make sure that the product you wish to  purchase is clearly and completely defined.

  • Make sure that your subcontractors understand  exactly what you want to purchase.

  • Make sure that your purchasing documents  refer to all relevant quality system standards.

  • Make sure that inspection and testing instructions  are clearly and completely defined.    

  • Make sure that your purchasing documents  are approved before they are released.

Control your subcontractors 

• Monitor and control your subcontractors and suppliers.

  • Develop procedures to ensure that subcontractors  are competent. Ensure their competence by:

    • Evaluating subcontractor products and facilities. 

    • Checking subcontractors' historical performance. 

  • Develop a subcontractor feedback system. Such a system  should allow you to maintain a close working relationship  with the people who supply you with products and services.

  • Develop a procedure to manage disputes between you and your subcontractors.

  • Develop quality assurance agreements with your subcontractors.                               

  • Develop quality verification agreements with your subcontractors.                             

Develop quality
agreements with your subcontractors 

• Develop quality assurance agreements with your subcontractors. These agreements should help ensure that all subcontractor  products and services will meet your quality requirements.  Such agreements could specify that you will:

  • Rely on the subcontractor's own quality system.

  • Ask subcontractors to send inspection or test  data and documents with each shipment.

  • Ask subcontractors to send process control  records with every shipment.                     

  • Expect subcontractors to develop and implement  an ISO 9001, ISO 9002, or ISO 9003 quality system.

  • Expect the subcontractor to perform regular  independent quality audits.                    

  • Expect subcontractors to test or inspect  every shipment before it leaves.                         

  • Test or inspect every incoming shipment yourself.

• Develop quality verification agreements with your  subcontractors. These agreements should explain how conformance to requirements would be verified.

Control
incoming
products 

• Develop plans and procedures to control product receiving.  These plans and procedures must:

  • Prevent the unintentional use or misuse  of nonconforming products.                       

  • Ensure that all inspection tools and equipment  are available, calibrated, and ready for use.

  • Make sure that all receiving and inspection  personnel are suitably trained.                   

• Develop a product receiving and inspection  record keeping system in order to:                        

  • Monitor subcontractor performance.

  • Facilitate product traceability.

  • Analyze historical trends.

Control
process
quality 

• Develop and document plans, procedures, and work instructions  to control process conditions. These plans, procedures, and instructions should be used to control your:

  • Production

  • Products

  • Services

  • Materials

  • Supplies

  • Personnel

  • Practices

  • Workmanship

  • Standards

  • Packaging

  • Handling

  • Delivery

  • Software

  • Equipment

  • Environment

  • Utilities

• Define and document concrete standards of good workmanship  by using photographs, diagrams, and work samples.

  • Make sure that these workmanship standards are built  into all relevant procedures and instructions.

Verify
process
quality 

• Verify the quality of your process. At key points  in your process, verify the condition and status of:

  • Products

  • Materials

  • Hardware

  • Software

  • Services

  • Supplies

  • Production

  • Environment

• Develop and document plans and procedures to  verify the quality of both in process and final products.

• Develop and document procedures to test and  inspect every product quality (characteristic).

Monitor
process
quality 

• Monitor and control the relationship between process  variables and final product characteristics.

  • Document the relationship between process  variables and product characteristics.

  • Make sure that process personnel understand the relationship between process variables and product characteristics.

• Verify final product quality whenever process  quality cannot be reliably established.                     

Verify
process
capability 

• Make sure that your production process is capable  of producing the products you intend to produce.

  • Identify all of the processes that affect product  quality and verify that these processes can,  in fact, produce a quality product.

  • Develop methods to encourage personnel to improve the quality of all processes

TO SEE THE REST OF ISO 9004-1, PLEASE GO TO PAGE TWO.