December 17, 2009

QUALITY ASSURANCE

Quality
. Quality is perceived by the individuals in their own way · The needs of a customer must be understood. Customers expect services to match or exceed their expectations, at right time & at a price they can afford.
· Quality is - Customer Delight
Quality Assurance
· Moving from “CONFORMANCE TO EXCELLENCE”
· You cannot do today’s jobs with yesterday’s methods and still be in business tomorrow.
Definitions of Quality
W. E. Deming
Quality is meeting the (stated) requirements of the customer, now and in the future.
Joseph M. Juran
Fitness for Use.
ISO 9000:2008
Degree to which set of Inherent Characteristics fulfill requirements.
American Society of Quality
A product or service free of deficiencies

December 10, 2009

ISO 9001:2008 IMPLEMENTATION PLAN

1. Gap Analysis on the basis of ISO 9001:2008 - Month 012. Appointment of QMR (Quality Management Representative) - Month 023. Establishment of Quality Policy - Month 01 - 024. Setting Objectives & Targets & Achievement Plan - Month 01 - 025. Customer Survey - Month 01 - 056. Trainings

  • Introduction of ISO 9001:2008 - Month 03
  • Internal Auditing - Month 07
7. Documentation
7.1 Manuals

Quality Assurance Manual - Month 05 - 07
7.2 Quality System Procedures
  • Management Review - Month 01 - 07
  • Documentation & Record Control - Month 01 - 07
  • Human Resources - Month 01 - 07
  • Infrastructure Maintenance - Month 01 - 07
  • Internal Communication - Month 01 - 07
  • Customer Related Processes - Month 01 - 07
  • Purchasing - Month 01 - 07
  • Service Provision - Month 01 - 07
  • Internal Audits - Month 01 - 07
  • Improvement - Month 01 - 07
  • Monitoring & Measuring of Services & Processes - Month 01 - 07
  • Analysis of Data - Month 01 - 07
  • Design and Development - Month 01 - 07
  • Quality Plans - Month 01 - 07
  • Control of Non-conforming Services - Month 01 - 07
8. Implementation of QMS Documentation - Month 01 - 089. Internal Audit of QMS - Month 0810. Corrective & Preventive Action - Month 0811. Pre-Audit by Certifying Agency - Month 0812. Corrective & Preventive Action - Month 0813. Certification Audit and Hooooray :)


Steps involved in ISO9001:2008 Certification
The steps involved in any ISO9000 certification project are the following:
  • Gap Analysis: Assessment of existing quality management practices vis-a-vis ISO9001 requirements.
  • Orientation Training: Top/Senior Management orientation on ISO9001 requirements and action plans.
  • System Documentation: Preparation of quality manuals and design of quality record formats.
  • System Implementation: Implementation of quality system as per the quality manuals.
  • Company-wide Training: Training on ISO9000 clauses, Statistical Quality Control Techniques, and Quality Audit.
  • Internal Quality Audits: Periodic assessment of quality system implementation and corrective actions.
  • Pre assessment: Initial audit by Certifying agency, and, implementation of corrective actions.
  • Final Assessment: Certification audit by the Certifying agency and recommendation for certification

December 7, 2009

Overview of Six Sigma


One definition of “Six Sigma” is a target for quality characteristics of units produced by the engineered system being improved (Shina, 2002; Tadikamalla, 1994). It is a rating that signifies “best in class”, with only 3.4 defects per million units or operations.

A part or item is classified as defective if the desired measurement, denoted by X, is outside the upper or lower specification limits (USL or LSL). In addition to specifying the USL and LSL, a target value is specified, which typically is the midpoint between the USL and LSL.

The symbol sigma (σ) is a letter in the Greek alphabet used by modern people to describe variability. In Six Sigma, the common measurement index is defects per million opportunities and can include anything from a component, piece of material, line of code, an administrative form, time frame or distance. A sigma quality level offers an indicator of how often defects are likely to occur, where a higher sigma quality level indicates a process that is less likely to create defects. Consequently, as sigma level of quality increases, product reliability improves, the need for testing and inspection diminishes, work in progress declines, cycle time goes down, costs go down, and customer satisfaction goes up.

Six sigma is a condition of the generalized formula for process capability, which is defined as the ability of a process to turn out a good product. It is a relationship of product specifications to manufacturing variability, measured in terms of Cp or Cpk, or expressed as a numerical index. Six sigma is equivalent to Cp=2 or Cpk=1.5.The definition of the capability of the process or Cp is: (1.1)

Specifically, (1.2)

This formula can be expressed conceptually as,
Cp = product Specifications / manufacturing variability (1.3)
The equation for Cpk is: (1.4)

Six sigma is achieved when the product specifications are at of the manufacturing process corresponding to Cp=2 or Cpk=1.5. Design engineers normally set the product specifications, whereas manufacturing engineers are responsible for production variability. The object of increasing the process capability to six sigma is twofold: either increase the product specifications by widening them, or reducing the manufacturing variability. Either effort can have a positive effect on reaching six sigma.

An alternative and more common definition for “Six Sigma” methods, implied by Pande and Holpp (2001) and Watson (2002a), is a series of ordered activities with associated component methods (Allen, 2003). Six Sigma is a disciplined and quantitative approach involving setting up a system and process for the improvement of defined metrics in manufacturing, service, or financial processes. The approach drives the overall process of selecting the right projects based on an organization’s business goals and selecting and training the right people to obtain the results. Improvement projects follow a disciplined process defined by a system of five macro phases. These component methods derive from statistics, marketing, and optimization and are sequenced as Define, Measure, Analyze, Improve, and Control (DMAIC). In design projects the specifics of the DMAIC steps are often modified to DMADV;

Define customer requirements and goals for the product.
Measure and match performance to customer requirements.
Analyze and assess product design.
Design and implement new product.
Verify results and maintain performance.

The phases of DMAIC are described by Rasis, Gitlow and Popovich (2003a and 2003b) as follows:

Define Phase: Define the project’s objectives by identifying customer requirements often called “CTQs” “critical to quality”, develop a team charter and define process map.

• Identify the process or product for improvement, identify customers and translate the customer’s needs into CTQs.
• The team charter involves selection of team members and defining of roles, developing the problem and goal statements, determining project scope, setting project milestones and preparing a business case to gain management support.
• Do a high level process map connecting the customer to the process.

Measure Phase: Measure the existing systems. Establish valid and reliable metrics to help monitor progress towards the project goals. Customer expectations are defined to determine “out of specification” conditions.
• Identify and describe the potential critical processes/products. List and describe all of the potential critical processes obtained from brainstorming sessions, historical data, yield reports, failure analysis reports, analysis of line fallout and model the potential problems.
• Perform measurement system analysis. Determine precision, accuracy, repeatability and reproducibility of each instrument of gauge used in order to ensure that they are capable.

Analyze Phase: Analyze the system to identify ways to eliminate the gap between the current performance of the system or process and the desired goal. In this phase, project teams explore underlying reasons for defects. They use statistical analysis to examine potential variables affecting the outcome and seek to identify the most significant root causes. Then, they develop a prioritized list of factors influencing the desired outcome.
• Isolate and verify the critical processes. Narrow the potential list of problems to the vital few. Identify the input/output relationship which directly affects specific problems. Verify potential causes of process variability and product problems.
• Perform process and measurement system capability studies. Identify and define the limitations of the processes. Ensure that the processes are capable of achieving their maximum potential. Identify and remove all variation due to special causes. Determine what the realistic specifications are. Determine confidence intervals. A process is to be considered capable when it is in control, predictable, and stable.

Improve Phase: In this phase, project teams seek the optimal solution and develop and test a plan of action for implementing and confirming the solution.

The process is modified and the outcome is measured to determine whether the revised method produces results within customer expectations.
• Conduct design of experiment. Select design of experiment factors and levels, Plan design of experiment execution. Perform design of experiment to find out the most significant factor.
• Implement variability reduction designs/assessments. Implement permanent corrective action for preventing special cause variations. Demonstrate process stability and predictability.

Control Phase: Control the new system. Ongoing measures are implemented to keep the problem form recurring. Institutionalize the improved system by modifying policies, procedures, operating instructions and other management systems.
• Specify process control methods. Establish on-going controls for the process based on prevention of special cause variation using statistical process control techniques.
• Document the improvement processes. Record all the processes/steps in improvement phase using the decision tree and reaction plan.

The methods are generally taught in the context of system improvement projects and expertise is often characterized by an analogy to karate “belts”: “black belt”, “green belt”, etc. For thousands of participants at the lowest “green belt” level of accreditation, one of the main benefits of “Six Sigma” training is that it simplifies (through restriction) the sequence and choice of available techniques to apply to a particular case. Therefore, the value of the six sigma movement derives partly from standardization of problem solving methods and partly in how it guides people to suggest which techniques to apply in which order to an improvement project.

Contributing to the widespread deployment of Six Sigma is an abundance of anecdotal evidence attributing quality, productivity, and costs benefits to this particular quality improvement initiative. Scientific evidence to lead credence to the anecdotal evidence has been rather limited and exists primarily as small-sample case studies. Moreover, while the empirical results from these case studies have generally been atheoretical in nature, their conduct had not been governed by rigorous, a priori theory development.

Bisgaard and Freiesleben (2000) showed how defect elimination and prevention associated with a Six Sigma program can improve financial results. Their view was to do or not to do a project. Hild, Sanders, and Cooper (2000) discussed the different structures of Six Sigma based on processes type, continuous or discrete. Sanders and Hild (2000a and 2000b) outlined the importance of considering organizational issues in the structuring of successful Six Sigma projects. Snee (2001a) similarly stated that one of the keys was to understand the environment in order to tailor Six Sigma projects; type of company (manufacturing or service), type of function (operations, transactional, administrative, or new product development) and type of industry (assembly, processing, chemical, etc.). Pyzdek (2001b) pointed out the importance of selecting the right individual to act as project leader even before they are trained.

Pande, Neuman, and Cavanagh (2000) contributed probably the most complete and explicit version of the Six Sigma methods. Yet, even their version of the methodology leaves considerable latitude to the implementers to tailor approaches to applications and to their own tastes. This lack of standardization of the methodologies explains, at least in part, why the American Society for Quality did not have a certification process until 2001.

April 28, 2009

KAIZEN - The Quality Management System of Japan

It comes from the Japanese words ‘Kai’ meaning ‘change’ and “Zen” meaning ‘better, the combination of these words mean ‘change for betterment’. Once it is implemented as a continuous cycle it leads to “continuous improvement”. It's a soft and gradual method opposed to more usual western habits to scrap everything and start with new.

It’s a philosophy that defines management’s role in continuously encouraging and implementing small improvements involving everyone. It is the process of continuous improvement in small increments that make the process more efficient, effective, under control and adaptable. Improvements are usually accomplished at little to no expense, without sophisticated techniques or expensive equipment. It focuses on simplification by breaking down complex processes into their sub-processes and then improving them.

The Kaizen improvement focuses on the use of
  • Value-added and non-value-added work activities.
  • Muda; which refers to seven classes of waste i.e. over production, delays, excessive transportation, excessive and non value-added processing, excess inventory, wasted motion and defective parts.
  • Documentation of standard operating procedures.
  • The five S’s for workplace organization (five Japanese words)
    Seiko - proper arrangement
    Seiton - orderliness
    Seiketso - personal cleanliness
    Seiso - cleanup
    Shitsuke - discipline
  • Visual management by means of visual displays that everyone in the plant can use for better communication.
  • Just-in-time principles to produce only the units in the right quantities, at the right time and with the right resources.
  • Poka-yoke (fail-safing or mistake-proofing) - to prevent or detect errors.
  • Team dynamics, which include problem solving, communication skills and conflict resolution.

Kaizen relies heavily on a culture that encourages suggestions by operators who continually try to incrementally improve their job or process. An example of Kaizen type improvement would be the change in color of welding booth from black to white to improve operator’s visibility. This change results in a small improvement in weld quality and a substantial improvement in operator satisfaction.

Kaizen is controlled; It is not acceptable to let anybody change designs, layouts or standards for some pretended "improvement". Most often Kaizen is controlled by improvement groups and everybody, regardless of rank or position, is encouraged to suggest through suggestion submitting system. Suggestions will be discussed by authoritative committee. Suggestions likely to be turned into application are usually rewarded according to the global gain. Improvement idea can be a response to a problem exposed by Kaizen committee or come out spontaneously


KAIZEN Vs INNOVATION
Kaizen refers to continual improvements. Just carrying out business as usual contains the element of continuity but lacks the idea of improvement. Innovation refers to change or improvement but lacks continuity. Innovation with its strong innovative meaning is often a preferred way to carry out changes, improvements. Yet the Kaizen way and innovation are very different, the Kaizen approach is to make better use of existing resources.

While Kaizen uses small steps, conventional know-how and a lot common sense, innovation comes in big steps and pursues technological breakthroughs. Kaizen is effort-based, while innovation is investment-based. Kaizen constantly reviews the process to check results consistency with targets, while innovation looks for results only. Are they slow to come or seem out of reach? the whole process might be changed.The benefits to applying the principles of Kaizen are manifold. Solutions emphasize commonsense, low-cost approaches and continual adjustment, thus improvement becomes possible and further desirable. It is not even always necessary to gain upper management’s approval to make changes.


BENEFITS OF KAIZEN AND CONTINUOUS IMPROVEMENT

Kaizen involves every employee in making change--in most cases small, incremental changes. It focuses on identifying problems at their source, solving them at their source, and changing standards to ensure the problem stays solved. It's not unusual for Kaizen to result in 25 to 30 suggestions per employee, per year and to have over 90% of those implemented.

For example, Toyota is well-known as one of the leaders in using Kaizen. In 1999 at one U.S. plant, 7,000 Toyota employees submitted over 75,000 suggestions, of which 99% were implemented.

These continual small improvements add up to major benefits. They result in improved productivity, improved quality, better safety, faster delivery, lower costs, and greater customer satisfaction. On top of these benefits to the company, employees working in Kaizen -based companies generally find work to be easier and more enjoyable--resulting in higher employee moral and job satisfaction, and lower turn-over.

With every employee looking for ways to make improvements, you can expect results such as:

  • Kaizen Reduces Waste in areas such as inventory, waiting times, transportation, worker motion, employee's skills, over production, excess quality and in processes.
  • Kaizen improves space utilization, product quality, use of capital, communications, production capacity and employee retention.
  • Kaizen provides immediate results. Instead of focusing on large, capital intensive improvements, Kaizen focuses on creative investments that continually solve large numbers of small problems. Large, capital projects and major changes will still be needed, and Kaizen will also improve the capital projects process, but the real power of Kaizen is in the on-going process of continually making small improvements that improve processes and reduce waste


KAIZEN IMPLEMENTATION

Kaizen is a daily activity whose purpose goes beyond improvement. It is also a process that, when done correctly, humanizes the workplace, eliminates physical and mental hard work and teaches people how to do rapid experiments using the scientific method and how to learn to see and eliminate waste(Muda) in business processes.

Kaizen is often misunderstood and applied incorrectly, resulting in bad outcomes including, for example, layoffs. This is called "kaiaku" - literally, "change for the worse." Layoffs are not the intent of Kaizen. Instead, Kaizen must be practiced in tandem with the "Respect for People" principle. Without "Respect for People," there can be no continuous improvement. Instead, the usual result is one-time gains that quickly fade.

Importantly, Kaizen must operate with three principles in place: process and results (not results-only); systematic thinking (i.e. big picture, not solely the narrow view); and non-judgmental, non-blaming (because blaming is wasteful).

The only way to truly understand the intent, meaning, and power of KAIZEN is through direct participation, many, many times. The implementing of kaizen involes earnestly following these steps

  • Prepare people to accept change for the betterment.
  • Think of how to do it, and NOT why in cannot be done.
  • Do not make excuses. Start by questioning current procedures.
  • Do not seek perfection. Do it even if for only 50% of the target.
  • Correct mistakes at once.
  • Do not spend too much money for Kaizen.
  • Wisdom is brought out when faced with hardship.
  • Ask “WHY?” at least five times, and see root causes.
  • Seek the wisdom of ten people, rather than the knowledge of one.

Kaizen ideas are indefinite.


HOW TO FAIL AT KAIZEN

Kaizen is gradual improvement, though it may be implemented incorrectly as well, leading to a failure.

  • Go around telling everyone you have a great program to save the company — “right now.”
  • Believe that you know all the questions and have all of the answers to make Continuous Improvement work in your company.
  • Begin before discussing with your key people to decide what you want to accomplish.
  • Use your own personal vision to lead the effort instead of developing a set of long range goals for your company.
  • Believe in changing processes and systems alone without any attention to the company culture.
  • Expect and tolerate no failures or set-backs.