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Types of quality management systems

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Types of quality management systems

  1. 1. Types of quality management systems In this file, you can ref useful information about types of quality management systems such as types of quality management systemsforms, tools for types of quality management systems, types of quality management systemsstrategies … If you need more assistant for types of quality management systems, please leave your comment at the end of file. Other useful material for types of quality management systems: • • • • • • I. Contents of types of quality management systems ================== If you’ve ever held a child’s toy or operated a power tool, you’re probably familiar with ISO certifications. They apply to everything from industrial and household products and services to environmental regulations and much more. ISO also applies to management, particularly an essential structure for any company: The Quality Management System. This is the first of a 2-part article. Here we will briefly discuss the highlights of the ISO 9001 Quality Management System. Next month, we will follow up with examples of how Lean Principles help make the entire process more efficient and effective. Before we delve in the Quality Management System, here’s a little background on ISOstandards. ISO is the International Organization for Standardization, and they’re the world’s largest developer of international standards. As their website states, “ISO-International Standards ensure that products and services are safe, reliable and of good quality.” Their video explains in more depth. According the LaManna Alliance’s quality guru, Ed Klaczak of EJK Consulting Solutions, Inc, one of the most important standards for businesses is the ISO 9001, which provides the standard for a Quality Management System (QMS). “The QMS is the glue to the entire business operation,” Klaczak said. “It covers every facet of your organization, from sales to product development to operations. ” Why is instituting an effective QMS so important? Two main reasons:
  2. 2. 1. For the good of your organization. Using a Quality Management System ensures that you have a quality-based approach to your entire operation. As ISO states, “For business, (ISO Standards) are strategic tools that reduce costs by minimizing waste and errors and increasing productivity.” ISO 9001 outlines ‘best-practices’ for an organization. The standard tells you “WHAT” is important. Your organization needs to determine “HOW” best to implement the ISO requirements for your business. This can be relatively simple for a smaller, or start-up operation, but complex for a multi-site, international corporation. Lean Operations tools and techniques can help your organization implement systems/processes as efficiently as possible. 2. As an entry to new markets. Many Europe and Asia firms will not do business with your company (as their supplier) unless you have an ISO 9001 certification. With this certification, you can also gain access to additional customers. It can be a marketing tool even for customers that don’t require an IS0 9001 certification from their suppliers. The certification still serves as proof that you’re a quality-driven organization. self-disciplining, continually improving, driving down costs, etc. When push comes to shove, that may be a deciding factor in their purchasing decision. Now let’s take a closer look at what constitutes a QMS. The Eight Principles of a Quality Management System These principles are the macro-level ideals that define your QMS. As you read through them, you’ll understand why this is such an all-encompassing approach to quality. After each principle, you’ll see examples of the types of questions that ISO requires you to address within your QMS and prove (you’re walking the walk) during a certification audit. 1. Customer Satisfaction: How are you defining customer satisfaction? What metrics are you using? Are critical performance indicators improving? 2. Leadership: How well is your leadership team defined? How do they operate – is it hands- on firefighting, or do they take a results-oriented approach using a balanced scorecard? 3. Involvement of People: Is the organization autocratic, or does it take a bottom-up approach and involve its people in innovating and improving? 4. Process Approach: How well are the company’s processes defined? Do written procedures (Work Instructions) clearly reflect the process? Are they current? What’s the process to amend them, etc? 5. Systems Approach: What is the organizational structure, and how efficient is it at improving systems?
  3. 3. 6. Continual Improvement: What is the company doing to improve? How does it react to metrics and solve problems? Does the Management Team fully support CI initiatives with adequate resources and tools? 7. Factual Approach to Decision-Making and Problem Solving: How does the company solve problems? Is it organized and structured, or is it ad hoc? 8. Mutually Beneficial Supplier Relationships: How good are the suppliers for the company? Remember, you’re only as strong as your weakest link. In the same respect, your product quality is only as good as your worst supplier. Auditing the Quality Management System (QMS) Similar to Quality Assurance (QA) gates at the end of the production line prior to shipment, a QMS audit tests the effectiveness of your operational systems, processes and procedures. There are 2 types of Quality Management Systems audits. Internal audits are done by internal employees (self-correcting) and are a critical ‘feedback’ component of any Continuous Improvement process. External audits are independent and contractually administered by a 3rd party registrar. This is the basis that ISO certifications are granted, if your company is compliant (no major nonconformities observed). Management Review of the QMS More important than the audit is what the organization does with the findings. The audit provides the feedback. If the audit finds an issue, that means an “escaping defect” occurred. There are numerous Quality Improvement tools to help facilitate the correction of the defect(s). In addition, there should be a scheduled, recurring review by the Management Team to guarantee that improvements are put in place and that they are proving to be effective. No QMS is ‘perfect,’ but a healthy organization constantly works to improve itself. Remember, an internal audit provides ‘up-close’ feedback and an external audit provides ‘an outsiders opinion.’ Use this feedback to get better…in everything you do! The Elements of the ISO 9001 The ISO 9001 details numerous requirements (elements) that an organization must meet to be in compliance with the standards. (Recall this is the “WHAT” you have to do, not the “HOW.”) There are four ISO 9001 sections that apply to each organization. You can download snapshots of those images by clicking here. I’ve provided an excerpt of part of those requirements below:
  4. 4. This is a sample of section 4, which details general requirements of the QMS. Section 4.2.3 looks at the Control of Documents. It asks how does a company maintain its documentation? How does it keep things current? Ed Klaczak pointed out that when we refer to “documentation,” we’re not talking about a dusty, outdated, standard operating procedures manual that sits on the shelf. “That’s of no value to anyone,” he said. Documentation today might take the form of a computer terminal, where work instructions for a job are listed whenever a new order is processed. The instructions might serve as effective training for newcomers to a job, but they also help keep skilled workers updated on recent changes to the work instructions (so they don’t keep building it the “old way”). “A quality-driven company might have a system that shows pictures identifying a critical step in the process or even video on how a sequence of steps needs to be completed. Anything that guides the worker from not creating a defect” Klaczak explains. Where feasible, manual processes can be semi-automated or fully-automated, it further eliminates the potential for a defect(s) to occur. Show You The Money This is all great, but how does ISO 9001 look in action, and more importantly, how can it translate into money for your bottom line? In our post next month, we’ll provide you with both answers. Subscribe to my blog so you’ll get the post, along with my other weekly posts on strategies built for the bottom line. ================== III. Quality management tools 1. Check sheet
  5. 5. The check sheet is a form (document) used to collect data in real time at the location where the data is generated. The data it captures can be quantitative or qualitative. When the information is quantitative, the check sheet is sometimes called a tally sheet. The defining characteristic of a check sheet is that data are recorded by making marks ("checks") on it. A typical check sheet is divided into regions, and marks made in different regions have different significance. Data are read by observing the location and number of marks on the sheet. Check sheets typically employ a heading that answers the Five Ws:  Who filled out the check sheet  What was collected (what each check represents, an identifying batch or lot number)  Where the collection took place (facility, room, apparatus)  When the collection took place (hour, shift, day of the week)  Why the data were collected 2. Control chart Control charts, also known as Shewhart charts (after Walter A. Shewhart) or process-behavior charts, in statistical process control are tools used to determine if a manufacturing or business process is in a state of statistical control. If analysis of the control chart indicates that the process is currently under control (i.e., is stable, with variation only coming from sources common to the process), then no corrections or changes to process control parameters are needed or desired. In addition, data from the process can be used to predict the future performance of the process. If the chart indicates that the monitored process is not in control, analysis of the chart can help determine the sources of variation, as this will
  6. 6. result in degraded process performance.[1] A process that is stable but operating outside of desired (specification) limits (e.g., scrap rates may be in statistical control but above desired limits) needs to be improved through a deliberate effort to understand the causes of current performance and fundamentally improve the process. The control chart is one of the seven basic tools of quality control.[3] Typically control charts are used for time-series data, though they can be used for data that have logical comparability (i.e. you want to compare samples that were taken all at the same time, or the performance of different individuals), however the type of chart used to do this requires consideration. 3. Pareto chart A Pareto chart, named after Vilfredo Pareto, is a type of chart that contains both bars and a line graph, where individual values are represented in descending order by bars, and the cumulative total is represented by the line. The left vertical axis is the frequency of occurrence, but it can alternatively represent cost or another important unit of measure. The right vertical axis is the cumulative percentage of the total number of occurrences, total cost, or total of the particular unit of measure. Because the reasons are in decreasing order, the cumulative function is a concave function. To take the example above, in order to lower the amount of late arrivals by 78%, it is sufficient to solve the first three issues. The purpose of the Pareto chart is to highlight the most important among a (typically large) set of factors. In quality control, it often represents the most common sources of defects, the highest occurring type of defect, or the most frequent reasons for customer complaints, and so on. Wilkinson (2006) devised an
  7. 7. algorithm for producing statistically based acceptance limits (similar to confidence intervals) for each bar in the Pareto chart. 4. Scatter plot Method A scatter plot, scatterplot, or scattergraph is a type of mathematical diagram using Cartesian coordinates to display values for two variables for a set of data. The data is displayed as a collection of points, each having the value of one variable determining the position on the horizontal axis and the value of the other variable determining the position on the vertical axis.[2] This kind of plot is also called a scatter chart, scattergram, scatter diagram,[3] or scatter graph. A scatter plot is used when a variable exists that is under the control of the experimenter. If a parameter exists that is systematically incremented and/or decremented by the other, it is called the control parameter or independent variable and is customarily plotted along the horizontal axis. The measured or dependent variable is customarily plotted along the vertical axis. If no dependent variable exists, either type of variable can be plotted on either axis and a scatter plot will illustrate only the degree of correlation (not causation) between two variables. A scatter plot can suggest various kinds of correlations between variables with a certain confidence interval. For example, weight and height, weight would be on x axis and height would be on the y axis. Correlations may be positive (rising), negative (falling), or null (uncorrelated). If the pattern of dots slopes from lower left to upper right, it suggests a positive correlation between the variables being studied. If the pattern of dots slopes from upper left to lower right, it suggests a negative correlation. A line of best fit (alternatively called 'trendline') can be drawn in order to study the correlation between the variables. An equation for the correlation between the variables can be determined by established best-fit procedures. For a linear correlation, the best-fit procedure is known as linear
  8. 8. regression and is guaranteed to generate a correct solution in a finite time. No universal best-fit procedure is guaranteed to generate a correct solution for arbitrary relationships. A scatter plot is also very useful when we wish to see how two comparable data sets agree with each other. In this case, an identity line, i.e., a y=x line, or an 1:1 line, is often drawn as a reference. The more the two data sets agree, the more the scatters tend to concentrate in the vicinity of the identity line; if the two data sets are numerically identical, the scatters fall on the identity line exactly. 5.Ishikawa diagram Ishikawa diagrams (also called fishbone diagrams, herringbone diagrams, cause-and-effect diagrams, or Fishikawa) are causal diagrams created by Kaoru Ishikawa (1968) that show the causes of a specific event.[1][2] Common uses of the Ishikawa diagram are product design and quality defect prevention, to identify potential factors causing an overall effect. Each cause or reason for imperfection is a source of variation. Causes are usually grouped into major categories to identify these sources of variation. The categories typically include  People: Anyone involved with the process  Methods: How the process is performed and the specific requirements for doing it, such as policies, procedures, rules, regulations and laws  Machines: Any equipment, computers, tools, etc. required to accomplish the job  Materials: Raw materials, parts, pens, paper, etc. used to produce the final product  Measurements: Data generated from the process that are used to evaluate its quality  Environment: The conditions, such as location, time, temperature, and culture in which the process operates 6. Histogram method
  9. 9. A histogram is a graphical representation of the distribution of data. It is an estimate of the probability distribution of a continuous variable (quantitative variable) and was first introduced by Karl Pearson.[1] To construct a histogram, the first step is to "bin" the range of values -- that is, divide the entire range of values into a series of small intervals -- and then count how many values fall into each interval. A rectangle is drawn with height proportional to the count and width equal to the bin size, so that rectangles abut each other. A histogram may also be normalized displaying relative frequencies. It then shows the proportion of cases that fall into each of several categories, with the sum of the heights equaling 1. The bins are usually specified as consecutive, non-overlapping intervals of a variable. The bins (intervals) must be adjacent, and usually equal size.[2] The rectangles of a histogram are drawn so that they touch each other to indicate that the original variable is continuous.[3] III. Other topics related to Types of quality management systems (pdf download) quality management systems quality management courses quality management tools iso 9001 quality management system quality management process quality management system example quality system management quality management techniques quality management standards quality management policy quality management strategy quality management books