Introduction to Quality

Quality fundamentals Quality: In terms of an excellent product or services, that fulfills or exceeds out expectations. Expectations: Are based on the intended use and the selling price. Eg: plain steel washer ~ chrome-plated steel washer (both are different grade and cost + intended use) y y y If a product or service surpasses customer expectations we consider that quality It is a perception As Quality = performance / expectations (=1 OK, < 1 bad, > 1 good)

According to ANSI /ASQC, quality is the totality of features and characteristics of a product or service that bear on its ability to satisfy implied or stated needs. Stated needs: Contract / something written. Implied needs: Function of market & must be identified & defined. Need involves: o o o o o o o Safety Availability Maintainability Reliability Usability Environment Economics (price)

Translated into specifications measureable and quantifiable.

Needs change over time Quality Control:

specifications need to be re-evaluated periodically.

It is the use of techniques and activities to achieve, sustain and improve the quality of a product or service. It involves integrating the following related techniques and activities: 1. Specifications what is needed 2. Design of the product or services to meet the specifications

3. Production and installation to meet the full intent of the specifications 4. Inspection to determine conformance to specifications 5. Review of usage to provide information for revision of specifications, if needed. Aim Continued improvement.

Statistical Quality Control (SQC): It is a branch of Quality control (QC). It is the collection, analysis, and interpretation of data for use in quality control activities. Following are two major parts of SQC: o Statistical process control o Acceptance Sampling SPC

Quality Assurance: All the planned or systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality is called quality assurance. It includes: o quality parameters for continuous evaluation for adequacy & effectiveness. o Corrective measures o Feedback initiated where necessary QC & QA difference: QC involved with the activities of specifications, design, production / installation, inspection & review of usage Responsibility of the functional areas QA Also involved with the above activities as well as the entire quality system.

Quality assurance versus quality control: Quality control emphasizes testing of products to uncover defects, and reporting to management who make the decision to allow or deny the release, whereas quality assurance attempts to improve and stabilize production, and associated processes, to avoid, or at least minimize, issues that led to the defects in the first place. To prevent mistakes from arising, several QA methodologies are used. However, QA does not eliminate the need for QC: some product parameters are so critical that testing is still essential. QC activities are treated as one of the overall QA processes. Failure testing:

A valuable process to perform on a whole consumer product is failure testing or stress testing. In mechanical terms this is the operation of a product until it fails, often under stresses such as increasing vibration, temperature, and humidity. This exposes many unanticipated weaknesses in a product, and the data are used to drive engineering and manufacturing process improvements. Often quite simple changes can dramatically improve product service, such as changing to mold-resistant paint or adding lockwasher placement to the training for new assembly personnel. Statistical control: Many organizations use statistical process control to bring the organization to Six Sigma levels of quality, in other words, so that the likelihood of an unexpected failure is confined to six standard deviations on the normal distribution. This probability is less than four one-millionths. Items controlled often include clerical tasks such as order-entry as well as conventional manufacturing tasks. Traditional statistical process controls in manufacturing operations usually proceed by randomly sampling and testing a fraction of the output. Variances in critical tolerances are continuously tracked and where necessary corrected before bad parts are produced. Total quality management Invariably, the Quality of output is directly dependent upon that of the participating constituents, some of which are sustainably and effectively controlled while others are not. The fluid state spells lack of Quality control, and the process(es) which are properly managed for Quality such that Quality is assured, pertain to Total Quality Management.

The major problem which leads to a decrease in sales was that the specifications did not include the most important factor, What the specifications have to state in order to satisfy the customer requirements?. The major characteristics, ignored during the search to improve manufacture and overall business performance were:
y y y y

Reliability Maintainability Safety Strength

As the most important factor had been ignored, a few refinements had to be introduced: 1. Marketing had to carry out their work properly and define the customers specifications. 2. Specifications had to be defined to conform to these requirements.

3. Conformance to specifications i.e. drawings, standards and other relevant documents, were introduced during manufacturing, planning and control. 4. Management had to confirm all operators are equal to the work imposed on them and holidays, celebrations and disputes did not affect any of the quality levels. 5. Inspections and tests were carried out, and all components and materials, bought in or otherwise, conformed to the specifications, and the measuring equipment was accurate, this is the responsibility of the QA/QC department. 6. Any complaints received from the customers were satisfactorily dealt with in a timely manner. 7. Feedback from the user/customer is used to review designs. 8. Consistent data recording and assessment and documentation integrity. 9. Product and/or process change management and notification. If the specification does not reflect the true quality requirements, the product's quality cannot be guaranteed. For instance, the parameters for a pressure vessel should cover not only the material and dimensions but operating, environmental, safety, reliability and maintainability requirements. Responsibility for Quality: Quality is not the responsibility of any one person or department, it is everyones job. Quality Management System (QMS): is process based. Process: Set on steps / instructions to achieve / deliver the requirements using available resources within the constraints of standards. Process refers to business & production activities of an organization. It must be effective, efficient, under control, and adaptable. Customer defines the purpose of an organization and every process within. Business process includes: o o o o Purchasing Engineering Accounting Marketing

Inputs to a process may be: Material

output from a process Information

Money Information Data

Data product/s services

FEEDBACK

INPUT Material Money Information Data, etc

PROCESS OUTPUT People Information Equipment Data Method Product Procedure Services, etc Environment Materials OUTCOMES

CONDITION SS

INPUT / OUTPUT process Model (TQM, 3rd Ed, Basterfield)

All processes have at least one owner

one performing the activities

Frequently the processes will cross multiple organizational boundaries, and supporting sub-processes will be owned by individuals with in each of the organizations. Improvements: Five (5) ways to improve: 1. 2. 3. 4. 5. Reduce resources Reduce errors Meet or exceed expectations of downstream customers Make process safer Make the process more satisfying to the person doing it

Ultimate goal of QMS: Customer satisfaction by continuous improvements. Approaches to improvement: 1. Jurans Trilogy for quality improvement: It is based on cost oriented perspective. It has three components: Planning, control, and improvement. It is based loosly on financial processes such as budgeting (planning), expense measurement (control), and cost reduction (improvement). 2. Shewharts Plan-Do-Study-Act cycle (PDSA) approach to continuous improvement which was further modified by Deming as Plan-Do-Check-Act (PDCA) approach to continual improvement. 3. Kaizen approach [Japanese approach]: Managements role in continuously encouraging and implementing small improvements involving everyone. a. Making small incremental improvements to the individual and the organization b. Behavioral approach. Evolution of Quality:

+ company-wide performance measures & control

Quality Management

+ Process measures & control

Quality Assurance Quality Control

Individual Product measures & control

Inspection
Improving Quality

Process Control Model y y y

Defect identification level / model Inspection production Model Sampling Production Model

Reference from ISO-9001