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Today we are going to discuss the relationship between the PMBOK Project Quality Management and the ISO 9000 series framework.

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Project Quality Management (PMBOK)History of ISO ANSI/ISO/ASQ Q9000 SERIES

Quality Management System (QMS)Summary


Plan Quality (Planning) Perform Quality Assurance (Executing)Perform Quality Control (Monitoring & Controlling)

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PMQ addresses the management of the project and the product of the project. Product quality measures and techniques are specific to the type of products produced by the project. The QM plan describes how the Project management team will implement the performing organizations quality policy. The basic approach to QM described in the PMBOK chapter 8 is intended to be compatible with the International Organization for Standardization (ISO). Failure to meet product or project quality requirements can have serious negative consequences for any or all of the project stakeholders. EXAMPLE: Meeting customer requirements by overworking the project team may result in increased employee attrition, Errors, or Re-Work. EXAMPLE: Meeting project schedule objectives by rushing planned quality inspections may result in undetected Errors. Quality and Grade are not the Same: Quality is: The degree to witch a set of inherent characteristics fulfill requirements. Grade is: A category assigned to products or services having the same functional use but, different Technical characteristics. Quality Metrics: is an operational definition that describes, in very specific terms, a project or product attribute and how the quality control process will measure it. A measurement is an actual value. The tolerance defines the allowable variation on the metrics. Quality metrics are used in QA and QC Exapmles: On-time performance Budget control Defect frequency Failure rate Availability Reliability Test coverage Precision and Accuracy are not Equivalent: Precision = means the values of repeated measurements are clustered and have very little scatter Accuracy = means that the measured value is very close to the true value “ Therefore one must conclude that precise measurements are not necessarily accurate, and a very accurate measurement is not necessarily precise “


JURAN = Human dimension to quality (Quality Planning, Control, and Improvement)DEMING = PDCA (Focus on continuous improvement)CROSBY = Prevention (ZERO defects)


Customer SatisfactionPrevention over InspectionContinuous ImprovementManagement ResponsibilityTools and Techniques

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There are two disciplines (conformance and non conformance) that recognize the importance of: Customer Satisfaction: Understanding, evaluating, defining and managing expectations so that customer requirements are met. Prevention over Inspection: One of the fundamental tenets of modern quality management states that quality is planned, designed and built-in not inspected-in. The cost of preventing mistakes is generally much less than the cost of correcting them when they are not found by inspection. Continuous Improvement: The PLAN-DO-CHECK-ACT cycle. This is the basis for quality improvement as defined by Shewhart and modified by Deming. Management Responsibility: Success requires the participation of all members of the project team. But remains the responsibility of management to provide the resources needed to succeed. Tools and Techniques are available to assist you to analyze and monitor the project: Control Chart, Run Chart, Cost Benefit Analysis, Statistical Sampling, Design of Experiments, Bench Marking Flow Charting, Scatter Diagram, Brain Storming, Affinity Diagram, Force Field Analysis, Bone Fish Diagram (Cause & Effect), Pareto Diagram, Histogram, Nominal Group Technique, Inspections, Matrix Diagram, Change Request


Cost of ConformanceCost of Nonconformance

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Cost of Quality - Refers to the total cost of all efforts related to quality throughout the product life cycle. Project decisions can impact operational costs of quality as a result of returns, warranty claims, and recall campaign's. Therefore due to the temporary nature of a project, the organization may chose to invest on product quality management, especially defect prevention and appraisal to reduce the external cost of quality. COST OF CONFORMANCE: (Money spent during the project to avoid failure) Prevention Cost (Build a Quality Product) are associated with the design, implementation and maintenance of the Quality Management System Training Quality planning Quality Assurance Equipment Time to do it right Appraisal Cost (Asses the Quality) are associated with suppliers and customers Verification Testing Inspections Vendor Ratings Destructive Testing Loss COST OF NONCONFORMANCE: (Money spent during and after the project due to failures) Internal Failure Cost: (Failure found by the Project) Occur when the results of work fail to reach designed quality standards and are detected before they are delivered to the customer Re-work Scrap Waste Failure Analysis External Failure Cost: (Failure found by the Customer) Occurs when the products or services fail to reach designed quality standards, but are not detected until after the transfer to the customer. Complaints Warranty Work Repairs and Servicing Returns Lost Business

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Total Quality Management (TQM)Validation and Verification QA vs QC

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TQM is a management approach for an organization, centered on quality, based on the participation of all its members and aiming at long-term success through customer satisfaction, and benefits to all members of the organization and to society. TQM requires that the company maintain this quality standard in all aspects of its business. This requires ensuring that things are done right the first time and that defects and waste are eliminated from operations A Comprehensive Definition TQM Total Quality Management is the management of total quality. We know that management consists of planning, organizing, directing, control, and assurance. Then, one has to define "total quality". Total quality is called total because it consists of 3 qualities : Quality of return to satisfy the needs of the shareholders Quality of products and services to satisfy some specific needs of the consumer (end customer) Quality of life - at work and outside work - to satisfy the needs of the people in the organization. The American Society for Quality says that the term Total Quality Management was first used by the U.S. Naval Air Systems Command "to describe its Japanese-style management approach to quality improvement.“ This is consistent with the story that the United States Navy Personnel Research and Development Center began researching the use of statistical process control (SPC); the work of Juran, Crosby, and Ishikawa; and the philosophy of W. Edwards Deming to make performance improvements in 1984. This approach was first tested at the North Island Naval Aviation Depot , Formally known as NADEP. Company’s that has established, documented, implemented a QMS in accordance with the requirements of ISO 9001 are in front of the QUALITY power curve. QMS is maintained and continually improved through the use of quality policy, quality objective, audit results, analysis of data, corrective & preventive actions and management review.. The difference is that QA is PROCESS oriented and QC is PRODUCT oriented. Quality assurance (QA) is the activity of providing evidence needed to establish confidence among all concerned, that quality-related activities are being performed effectively. All those planned or systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality. Quality Control (QC) is the process by which product quality is compared with applicable standards; and the action taken when nonconformance is detected. An activity which verifies if the product meets pre-defined standards and Implements the process.

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AdvantagesDis-Advantages

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Advantages It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9000:2000 are also sound, according to Wade and also to Barnes, who says that "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Implementing ISO often gives the following advantages: Creates a more efficient, effective operation Increases customer satisfaction and retention Reduces audits Enhances marketing Improves employee motivation, awareness, and morale Promotes international trade Increases profit Reduces waste and increases productivity. Dis-Advantages A common criticism of ISO 9001 is the amount of money, time, and paperwork required for registration. According to Barnes, "Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed." Wilson suggests that ISO standards "... elevate inspection of the correct procedures over broader aspects of quality," and therefore, "the workplace becomes oppressive and quality is not improved." According to Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement.[7] Wade argues that ISO 9000 is effective as a guideline, but that promoting it as a standard "helps to mislead companies into thinking that certification means better quality, ... [undermining] the need for an organization to set its own quality standards." [32] Paraphrased, Wade's argument is that reliance on the specifications of ISO 9001 does not guarantee a successful quality system. While internationally recognized, most consumers are not aware of ISO 9000 and it holds no relevance to them. The added cost to certify and then maintain certification may not be justified if product end users do not require ISO 9000. The cost can actually put a company at a competitive disadvantage when competing against a non-ISO 9000-certified company. The standard is seen as especially prone to failure when a company is interested in certification before quality. Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality. "If you just want the certificate on the wall, chances are you will create a paper system that doesn't have much to do with the way you actually run your business," said ISO's Roger Frost. Certification by an independent auditor is often seen as the problem area, and according to Barnes, "has become a vehicle to increase consulting services." In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved. Another problem reported is the competition among the numerous certifying bodies, leading to a softer approach to the defects noticed in the operation of the Quality System of a firm. Abrahamson argues that fashionable management discourse such as quality circles tends to follow a lifecycle in the form of a bell curve, possibly indicating a management fad.


ISO 9000 - Quality ManagementISO 9001 - Quality Management Systems -RequirementsISO 9004 - Quality Management Systems -Guidelines for Performance Improvement

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Three Component standards The first standard provides definitions to understand the intent of the set (fundamentals and vocabulary), the second supplies the requirements, and the third gives guidelines for performance excellence and improvements. Taken together, the standards are components because they form a complete tactical approach to quality management. Components standards are generally recognized in the legal system. In the United States, guidance standards such as ISO 9000 and ISO 9004 are considered components of a series, along with ISO 9001. guidance documents that are part of a series can be used to establish a company’s due diligence and duty of care, and can be used by courts to establish evidence of negligence or a design defect. A plaintiff could argue that the issues raised by ISO 9004 should be considered first by every organization establishing a quality management system and integrated into its QMS before registering to IOS 9001. ISO 9000 is a family of standards for Quality Management. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. ISO 9001 Supplies the quality requirements (systemic clauses) SOPs. A set of good business practices that are known to either contribute to the quality of product and service, or in their absence invite quality failure. ISO 9001 contributes comprehensively, covering activities in four general categories: Management Resources Operations Improvement Within these categories each requirement serves as an instruction , teaching the reader the elements necessary to achieve the requirement. ISO 9004 Supplies the guidelines for performance excellence. It expands many of the clauses of the ISO 9001 The requirements cover everything from how you plan your processes, to how you carry them out, measure them and improve them. The standard calls your production processes "Product Realization". This is where you are actually making your product or delivering your service with great precision and excellence. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) includes: 1) A set of procedures that cover all key processes in the business 2) Monitoring processes to ensure they are effective 3) Keeping adequate records 4) Evaluating the output for defects, with appropriate corrective action where and when necessary 5) Regularly reviewing individual processes and the quality system itself for effectiveness 6) Facilitating continual improvement


In the beginning (WWII)1987 Version 1994 Version 2000 Version 2008 VersionFuture Version: ?

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ISO (International Organization of Standardization) is a world wide federation of national standard bodies(ISO member bodies). The work in preparing international standards is normally carried out through ISO technical committees. Each member interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO also take part in the work. ISO collaborates closely with the International Electro technical Commission (IEC) on all matters of Electro technical standardization. International Standard ISO/9001 was prepared by Technical Committee ISO/TC176, Quality Management and Sub-Committee SC2, Quality Systems. History: During WWII, there were quality problems in many British high-tech industries such as munitions, where bombs were exploding in factories during assembly. The adopted solution was to require factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The name of the standard was BS 5750, and it was known as a management standard because it did not specify what to manufacture, but how to manage the manufacturing process. According to Seddon, "In 1987, the British Government persuaded the International Organization for Standardization to adopt BS 5750 as an international standard. BS-5750 became ISO/9000. ISO 9000:1987 had the same structure as the UK Standard BS-5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization. ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products. ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products. ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced. ISO 9000:1994 emphasized quality assurance via preventative actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system . ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, now called 9001. Design and development procedures are required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and centre. ("Process management" was the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product.) The 2000 version also demands involvement by upper executives, in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal is to improve effectiveness via process performance metrics — numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit. Current Version: TC-176 (the ISO 9001 Technical Committee), released ISO 9001:2008 in late 2009. Early reports were that the standard will not be substantially changed from its 2000 version. As with the release of previous versions, organizations registered to ISO 9001 will be given a substantial period to transition to the new version of the standard, assuming changes are needed; organizations registered to 9001:1994 had until December of 2003 to undergo upgrade audits.


1.0 - 3.0 Administrative Procedures4.0 - 8.0 Quality ManagementQuality PolicyObjectives and Measurements ProcessesProceduresWork Instructions (WI)Records

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ISO 9001:2008 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. It is supplemented by two other standards, ISO 9000:2005 Quality Management Systems — Fundamentals and Vocabulary ISO 9004:2009 Managing for the Sustained Success of an Organization — A quality management approach, which do not contain specific requirements and are not used directly in certification. Outline contents for ISO 9001 are as follows: Page iv: Foreword Pages v to vii: Section 0 Intro Pages 1 to 14: Requirements Section 1: Scope Section 2: Normative Reference Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000) Pages 2 to 14 132 1 Section 4: Quality Management System Section 5: Management Responsibility Section 6: Resource Management Section 7: Product Realization Section 8: Measurement, analysis and improvement In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS. Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards Page 23: Bibliography The standard specifies six compulsory documents: Control of Documents (4.2.3) Control of Records (4.2.4) Internal Audits (8.2.2) Control of Nonconforming Product / Service (8.3) Corrective Action (8.5.2) Preventive Action (8.5.3)


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ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) would include: 1) A set of procedures that cover all key processes in the business 2) Monitoring processes to ensure they are effective 3) Keeping adequate records 4) Checking results for defects, with appropriate corrective action where necessary 5) Regularly reviewing individual processes and the quality system itself for effectiveness 6) Facilitating continual improvement A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered." Certification to an ISO 9000 standard does not guarantee the compliance (and therefore the quality) of end products and services; rather, it certifies that consistent business processes are being applied. Although the standards originated in manufacturing, they are now employed across a wide range of other types of organizations. Having an effective Quality Management System, (QMS) in place leads to improvements in any organization. ISO/9001 is a proven foundation for an effective QMS. It provides benefits to the operations of any company.


Increased productivityLess scrap and reworkIncreased employee satisfactionContinual ImprovementIncreased profits (Cost of Quality)Motivate staff by defining their key roles and responsibilities

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It will ensure that have the training and information to do the job correctly. Systems are in place to identify problems, find the cause and eliminate it to prevent problems from reoccurring. True direction for job accomplishment and ownership of product produced. The requirements cover everything from how you plan your processes and how you execute them, including how you measure them, and improve them. The standard calls your production processes "Product Realization". This is where you are actually making your product or delivering your service. Management must ensure that systems have been established to determine and meet customer requirements It is up to each and every employee to work to meet customer requirements. Customer Satisfaction is “ How does the customer perceive your performance in meeting requirements”


Marketing and Increased Business Opportunities An Internationally Recognized Certification/RegistrationIncreased Customer and Stakeholder Satisfaction due to customer focus


Quality goals are established to support the quality policy. They should be specific and measurable. “OBJECTIVES"

1. Excellent Customer Comment Ratings 2. All deliveries on schedule (NO late deliveries )3. Establish Assembly Performance Measurement 4. Establish Assembly Production Measurement5. 100% of all production products will be completed with ZERO defects6. 100% ERROR free final delivery of documents

QUALITY GOALS


Top Management has to established a Quality Policy for the organization. Readily displayed and visible for employeesCompany X , Panama City, strives to set the standard of

high quality products and services in the industry. We will strive to become the PREFERRED choice of the customer base by making quality synonymous with the Company X Name. Promote open communications among our employees and management to inspire and improve the quality standard. Encourage suggestions and methods to ensure we remain the standard bearer that other companies wish to emulate.


Processes must be controlledConsistency is desiredDetailed “How To “ perform the work that is required (Work Instructions)

Standard Operations Procedures (SOP)

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Process: A well controlled process will be performed constantly day to day, employee to employee. Consistency is achieved by: Training or qualifying employees to perform the process, Documenting the process, Providing information on process characteristics or product characteristics. To maintain quality and prevent mistakes, your product and materials must be clearly identified throughout production and delivery.�


Are generated as needed, to describe the specific methods and actions necessary to produce products Feedback and Improvements are desired and welcomedWork Instructions are maintained by the applicable department supervisors and are approved by the QM

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As you perform your work, you will need to follow documented work instructions and procedures. Step-by-Step procedures with illustrations for greater understanding of products or services produced Make sure that you are using a controlled copy of the documentation (WI). By using the controlled copy, you will be confident that you are using the current, correct documentation. (Signed by the company VP) is the approved authorized WI for company use.


Quality Control Inspection (QC Checks)Action ReportsProject PlanPurchase OrdersInspection ReportsDelivery OrderInventoryVendor Performance Non-Conformance Log

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Several categories in the Action Report: Preventative Corrective Non-Conformance Audit Results Customer Complaint Opportunity for Improvement


Corrective and Preventive Action Systems should be used by management and all employees to address problems and potential problems.1. Corrective Action: Fix a problem that has occurred, and

prevent it from happening again.2. Preventive Action: When you see something that may

cause a problem, fix it and prevent the problem from happening.


INTERNAL AUDITS – Measure and monitor how well the QMS is being followed

1. Tell me what you do (describe the business process)

2. Show me where it says that (reference the procedure manuals)

3. Prove that this is what happened (exhibit evidence in documented records)

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It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments. ISO/9001: Internal audits are required by ISO 9001:2008 standard. These audits are to be performed on a regular basis and verify that the quality management system conforms to: The documented plans for product production (planned process) The requirements of ISO 9001 The organizations quality management system requirements Two types of audits are required to become registered to the standard: Auditing by an external means (certification body) and audits by internal staff trained for this process. The aim is a continual process of review and assessment, to verify that the system is working as it's supposed to, find out where it can improve and to correct or prevent problems identified. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments. Show me where it says that (reference the procedure manuals) Prove that this is what happened (exhibit evidence in documented records) Measure the effectiveness of the QMS Allows for making adjustments (to fix problems) with the QMS Allows for making improvements to the QMS


EXTERNAL AUDITS -1. To meet the certification and registration

requirements2. Surveillance Audits occur once a year to

maintain certification3. Re-certifications Audits occur every three

years

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Independent reviewPerformed on a regular basisQuality management activities Lessons learned repository

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(PMBOK) Quality Audit is a structured, independent review to determine whether project activities comply with organizational and project policies, processes and procedures. The objectives of a quality audit are: Identify all the good/best practices being implemented Identify all the gaps/shortcomings Share the good practices introduced or implemented in similar projects in the organization and/or industry Proactively offer assistance in a positive manner to improve implementation of processes to help the team raise productivity Highlight contributions of each audit in the lessons learned repository of the organization.


Top 10 countries / ISO 9001 Certificates Rank Country No. of certificates

1 China 257,076

2 Italy 130,066

3 Japan 68,484

4 Spain 59,576

5 Russian Federation 53,152

6 Germany 47,156

7 United Kingdom 41,193

8 India 37,493

9 USA 28,935

10 Korea, Republic of 23,400

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A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered." Certification to an ISO 9000 standard does not guarantee the compliance (and therefore the quality) of end products and services; rather, it certifies that consistent business processes are being applied. Although the standards originated in manufacturing, they are now employed across a wide range of other types of organizations.


ISO/TS 16949 – Automotive IndustryISO 13485 – Medical Industry (Devices)ISO 22000 – Food Safety ManagementISO 14001 – Environmental ManagementISO/IEC 90003 – Computer SoftwareISO/TS 29001 – Petroleum, Petrochemical, and Natural Gas IndustriesAS9100 QMS – International Aerospace Industry (Aviation)

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1. The International Aerospace Quality Group released this revised Quality Management standard tailored toward aviation, space, and defense industries. The revised standard includes elements of the ISO 9001 and additional requirements specific to the aerospace industry relating to quality and safety. 2. The automotive industry QMI is the company that performs external audits


Project Quality Management (PMBOK) relationship with ISO/9001 Quality Management Standards-RequirementsReasons for a formal Quality SystemFramework for Quality Systems

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1. Organizations begin the quality system improvement process for a number of reasons. Sometimes they are forced by their customers. Sometimes management recognizes the need to seize control of operations that are costing too much money. Management want to improve operations: Control the business Document methods of achieving goals Clarify policies Standardize processes Identify required actions for control Assist in training Harmonize inter department relationships Management wants to save money: Improve efficiency of operations Reduce scrap and wasted efforts Reduce redundant operations and personnel 2. Almost any business of reasonable size, that does not have a formal quality system, will be helped by implementing a system based on the ISO 9001:2008 standard. However. Management’s perception for the justification is as important to the success as the actual program itself. Trivial justification are almost bound to fail because the management commitment will soon fade. The most powerful justification for a formal quality system is managements' belief that a quality system can improve the business and save money. We are an ISO/9001 certified company and we need to function as such WI’s need to be used QC sheets need to be accomplished Action Reports need to be accomplished View the Website and see the processes and procedures and the Project Plan.

Panama City BranchPanama City Branch QUALITY MANAGEMENT SYSTEM (QMS)


Where can I learn more about Quality ?Visit: www.asq.org

Where can I get ISO 9001:2008 information?Visit: www.the9000store.com

www.iso.org

See ya . . .