Revised Edition of Training Handbook on 'ISO 9001:2015 QMS Awareness'

Revised Edition of Training Handbook on 'ISO 9001:2015 QMS Awareness' released at reduced Support Contribution.

CONTENTS

# 01 - Learning objectives
# 02 - Historical background
# 03 - Standard development timeline for ISO 9001:2015
# 04 - Why new version?
# 05 - Key feature changes
# 06 - Structure and terminology
# 07 - Meaning of certain terms
# 08 - Foreword of the standard
# 09 - Introduction
# 10 - ISO 9001:2015 clauses in brief
# 11 - Context of the organization
# 12 - Leadership
# 13 - Management representative in ISO 9001:2015 QMS?
# 14 - Planning
# 15 - Support
# 16 - Operation
# 17 - Performance evaluation
# 18 - Improvement
# 19 - Tips for organizations using ISO 9001:2008
# 20 - Transition Planning
# 21 - Developing and implementing ISO 9001:2015 QMS
# 22 - Risk-based Thinking - An integral part of ISO 9001:2015 QMS
# 23 - Understanding the process approach and PDCA
# 24 - Quality management principles
# 25 - Change management in ISO 9001:2015
# 26 - Adding value to the audit
# 27 - Evaluation questionnaire
# 28 - Feedback
# 29 - Acknowledgement


If you are interested to see the preview, please send an email to keshavsinghalajmer@gmail.com.

Thanks,

Keshav Ram Singhal

TRAINING HANDBOOK ON 'ISO 9001:2015 QMS - APPLYING RISK-BASED THINKING (RBT)'

TRAINING HANDBOOK
ON
ISO 9001:2015 QMS - APPLYING RISK-BASED THINKING (RBT)


CONTENTS

# 01 - Introduction

# 02 - The 2008 global financial crisis and risk management

# 03 - Definition of risk

# 04 - Nature and impact of risk

# 05 - Why we need risk-based thinking?

# 06 - Risk-based thinking in ISO 9001:2015 QMS

# 07 - Benefits of applying risk-based thinking

# 08 - Summarized hint for applying risk-based thinking

# 09 - Risk awareness culture in your organization

# 10 - Risk management or formal risk-based approach

# 11 - Process diagram for Risk-based thinking (RBT)

# 12 - Understanding the organization and its context, Step-by-step process

# 13 - External and internal issues of an organization, Some external issues, Some internal issues

# 14 - Format - Context of the organization - Determining external and internal issues

# 15 - Understanding the needs and expectations of interested parties

# 16 - Format - Determining interested parties and their needs and expectations

# 17 - Interested parties and their needs and expectations - A few examples

# 18 - Planning and addressing risks and opportunities

# 19 - Overview of risk assessment tools and techniques

# 20 - Brainstorming

# 21 - Check-lists

# 22 - Failure Modes and Effect Analysis (FMEA)

# 23 - Delphi technique for risk determination

# 24 - A simple method to determine risks and opportunities

# 25 - Format for determining risks and opportunities

# 26 - Examples of some risks

# 27 - Opportunities and a few examples

# 28 - Risk register

# 29 - Risk matrix and risk matrix chart diagram

# 30 - Conclusion

# 31 - Bibliography (a list of a few books and web pages)

# 32 - Evaluation Questionnaire

# 33 - Your feedback

# 34 - Acknowledgement

By attending the training and/or reading this literature, a participant will be able to understand:
- Concept of risk-based thinking,
- ISO 9001:2015 QMS requirements related to risk-based thinking,
- Benefits of using risk-based thinking,
- An overview of various risk assessment tools - Techniques and methodologies that you may apply in your QMS,
- Using risk-based thinking to achieve better internal controls.
- Demonstrating risk-based thinking during audits (internal and external).

If you are interested to see the Preview of the Training Handbook, please send an email to:
keshavsinghalajmer@gmail.com or krsinghal@rediffmail.com.

Delphi technique for risk determination

Delphi technique for risk determination

The Delphi technique can be used to determine risks. Delphi technique is an information-gathering technique used as a way to reach a consensus of experts on a subject. Experts on the subject participate in this technique anonymously. The Delphi Technique is a method used to estimate the likelihood and outcome of future events. A group of experts exchange views, and each independently gives estimates and assumptions to a coordinator, who reviews the data and thereafter prepares a summary report. The group members discuss and review the summary report, and give updated forecasts to the coordinator, who again reviews the updated data and prepares a second report. This process continues until all participants reach a consensus. This technique can be applied at any stage of the risk determination process or at any phase of a system life cycle, wherever a consensus of views of experts is needed.

The experts at each round have a full record of what forecasts other experts have made, but they do not know who made which forecast. Anonymity allows the experts to express their opinions freely, encourages openness and avoids admitting errors by revising earlier forecasts.

The technique is an iterative process. It first aims to get a broad range of opinions from the group of experts. A group of experts are questioned using a semi-structured questionnaire. The experts do not meet so their opinions are independent. The results of the first round of questions, when summarised, provide the basis for the second round of questions. Results from the second round of questions feed into the third and so on to final round. The aim is to clarify and expand on issues, identify areas of agreement or disagreement and begin to find consensus. Following steps should be undertaken:

- Select a Coordinator.
- Select experts for the group as the technique relies on a panel of experts.
- Define the issue of risk determination to the group members.
- Round one questions - Ask general questions to gain a broad understanding of the experts view. The questions may go out in the form of a questionnaire or survey. Collate and summarise the responses, removing any irrelevant material and looking for common viewpoints.
- Round two questions - Based on the answers to the first questions, the next questions should delve deeper into the risk determination to clarify specific issues. These questions may also go out in the form of a questionnaire or survey. Again, collate and summarise the results, removing any irrelevant material and look for the common ground. We should remember that the exercise is done to build consensus.
- Round three questions - The final questionnaire aims to focus on supporting decision making. Again, collate and summarise the results, removing any irrelevant material and look for the commonly agreed points. You may have more than three rounds of questioning to reach a closer consensus.
- Act on coordinator's findings - After the round of questions, hope that the team experts will have reached a consensus and the coordinator will have a view of future risks and opportunities. Analyse the findings and put plans in place to deal with future risks and opportunities.

Predicting the future is not an exact science, but the Delphi Technique can help in understanding the likelihood of future events and what impact they may have on the process, product and service. Delphi technique is labour intensive and time consuming, so a slow process. Since the opinion in Delphi technique needs to be expressed in writing, the participants need to be able to express themselves clearly in writing.

Understanding Statistical Tools and Techniques - 11 - PROCESS MAPPING

PROCESS MAPPING

Process mapping is a workflow diagram that brings forth a clear understanding of a process or a number of processes. A process map is a planning and management tool that visually describes the flow of work. Process map shows a series of events that produce an end result. A process map is also known as a flowchart, process flowchart, process chart, functional flowchart, functional process chart, process model, workflow diagram, business flow diagram or process flow diagram.

The purpose of process mapping is to gain better understanding of a process and to improve efficiency. It provides insight into a process. It helps the involved people to know the process steps and brainstorm ideas for process improvement. It is a documented information that increase communication.

Process mapping involves following steps:

Step 1 - Select the process for which process mapping is to construct and determine boundaries of the process - where to start (beginning of the process) and where to end (process end).

Step 2 - List all steps involved in the process with sufficient information.

Step 3 - Sequence all steps from start to end.

Step 4 - Draw process map by using appropriate symbols.

Step 5 - Check the flowchart for completeness and include pertinent information.

Step 6 - Finalize the flowchart.

Common process mapping symbols are described in the below figure:



How you liked the write-up. Please post your comments. Thanks.

- Keshav Ram Singhal

Understanding Statistical Tools and Techniques - 10 - STRATIFICATION

STRATIFICATION

Stratification is a statistical tool used in combination with other analysis tool. When data from a variety of sources or categories lump together, it is difficult to visualize the meaning of data. Stratification technique separates the data so that pattern of the data can be seen.

Stratification is a technique used to analyze or divide a universe of data into homogeneous groups (strata) often data collected about a problem or event represents multiple sources that need to be treated separately. It involves looking at process data, splitting it into distinct layers (almost like a rock is stratified) and doing analysis to possibly see a process improvement. Stratification is related to segmentation, but it is different from segmentation.



Following procedure will be useful:

- Before collecting data, consider the information and sources of data that can have effect on the results. Plan to collect stratification information.
- After collecting data, when you plot or graph the collected data on scatter diagram or control chart or histogram or any other analysis tool, use different marks or colours to differentiate data from various sources.
- Data plotted or graphed that differentiate from each other are said to be stratified.
- Analyze subsets of stratified data separately.




Some examples of different sources that may require data to be stratified are different equipment, shifts, departments, materials, suppliers, products, days or time.

Thus, analysis of survey data can be benefited from stratification technique.

How you liked the write-up. Please post your comments. Thanks.

- Keshav Ram Singhal

Understanding Statistical Tools and Techniques - 09 - SCATTER DIAGRAM

SCATTER DIAGRAM

A scatter diagram is a graphical representation of two variables showing the relationship between them. If variables are correlated, the points will fall along a line or a curve. This diagram is also known as a scatter plot, x-y graph, or correlation chart. It is a problem solving tool.

We can use scatter diagram when we may have paired numerical data and one variable data is dependent on other variable. Scatter diagram can be constructed by plotting two variables against one another on a pair of axes. With the help of scatter diagram, we can try to determine whether two variables are related and potential root causes of problems.



It will be useful to draw scatter diagram after brainstorming causes and effects using a cause and effect diagram to determine whether a particular cause and effect are related. A scatter diagram is used to uncover possible cause-and-effect relationship.

Following procedure will be useful to construct a scatter diagram:
- Decide two variables against which you wish to see the relationship
- Collect pairs of data of these two variables
- Draw a graph with independent variable on the horizontal axis and the dependent variable on the vertical axis
- For each pair of data, put a dot or symbol where x-axis value intersect y-axis value
- Look at the pattern of dots (or symbols) to see if a relationship is obvious
- If data form a line or a curve, it indicates that variables are correlated




When data forms a line or curve, then you may use regression analysis or correlation analysis by using following steps:
- Decide the points from top to bottom by drawing horizontal line
- Divide the points from left to right by drawing a vertical line
- If number of points is odd, you should draw the line through the middle point
- In this way, you will be able to divide points on the graph into four quadrants
- Count the points in each quadrant (leaving the point on the line)
- Add diagonally opposite quadrants
- Find smaller sum and total of points in all quadrants
- A = points in upper left + points in lower right
- B = points in upper right + points in lower left
- Q = the smaller of A and B
- N = A + B
- Look up the limit for N on the trend test table



- If Q is less than the limit, two variables are related
- If q is greater than or equal to the limit, the pattern could have occurred from random chance and we can say that no relationship is demonstrated

How you liked the write-up. Please post your comments. Thanks.

- Keshav Ram Singhal

Understanding Statistical Tools and Techniques - 08 - PARETO CHART

PARETO CHART

A Pareto chart looks like a bar graph, but it contains both bars and a line graph. It is one of the basic tools of quality control. The length of the bars in the graph represents frequency or cost (time or money). These bars are arranged with longest bar on the left and shortest to the right. This is a tool which can be used to analyze the ideas from brainstorming session. This tool is also known as Pareto diagram or Pareto analysis. This tool is used to identify the vital few problems or causes of problems that have the greatest impact on the process. This chart pictorially represents data in the form of a ranked bar chart that shows the frequency of occurrence of items in descending order. The Pareto chart is named after Wilfried Fritz Pareto, an Italian engineer, sociologist, economist, political scientist and philosopher. He introduced the concept of Pareto efficiency.



It is significant to use Pareto chart:

- To analyze data about frequency of problems or causes of problems in a process
- To focus on the most significant problem or cause, when there are many problems or causes
- To analyze broad causes
- To communicate with others about the data



Following procedure will be useful to use Pareto chart and its analysis:

- Decide the categories of group items
- Decide approximate measurement (frequency, quantity, cost, or time)
- Decide the time period to gather data and use in the Pareto chart (one work cycle, one full day, or one week)
- Collect data, record and assemble data for the category each time
- Subtotal the measurements for each category
- Determine the appropriate scale for the measurements data collected
- Mark the scale on the left side of the chart
- Construct and label bars for each category by placing the tallest to the left, next tallest to its right and so on
- Calculate the percentage for each category
- Draw a right vertical axis and label it with percentage in a graph paper. Be sure that left measurement corresponds to one-half and it should be exactly opposite 50% on the right scale.
- Calculate and draw cumulative sums
- Add the subtotals for the first category and second category and place a dot above the second bar indicating the sum, then add subtotal of third category to the sum and place a dot above the third bar indicating the new sum and so on. Continue the adding subtotals and placing dots for all bars.
- Connect the dots, starting from the top of first bar. The last dot should reach 100 percent on the right side

In this way we can visualize the most important factors among a typically large set of factors through the Pareto chart. A Pareto chart often represents the most common sources of defects, the highest occurring type of defect, or the most frequent reasons for problems.

How you liked the write-up. Please post your comments. Thanks.

- Keshav Ram Singhal

Understanding Statistical Tools and Techniques - 07 - HISTOGRAM

HISTOGRAM

A histogram is a snapshot of variation or distribution, where data are grouped into cells and their frequency represented as bars. It is a commonly used graph to show frequency distribution. It looks like a bar chart, but it is different from the bar chart. We can put the data from the check sheets into a histogram. A histogram is a set of vertical bars whose areas are proportional to the frequency represented.

The histogram helps in analyzing the capability of a process. The variables being measured are shown along x-axis and the frequency occurrences of each measurement is charted along y-axis.



A histogram is convenient for large amounts of data particularly when the range is wide. It gives a picture of the extent of variation. It highlights unusual areas and indicates probability of particular values occurring. Histogram depicts the central tendency or mean of the data and its variation or spread.

A histogram is useful in showing characteristics of the process being measured, such as:

- Whether results of the process show a normal distribution – a bell curve?
- Whether the range of the data indicates that the process is capable of producing product as per defined specifications?
- How much improvement is necessary to meet specifications?



It is convenient to use histogram when data are numerical and we want to see the shape of data distribution to determine whether the output of a process shows normal distribution.

Following procedure will be useful:

- Decide a process to observe
- Collect at least 50 consecutive data points from the process
- Use histogram worksheet to set up histogram
- Draw x- and y-axes on the graph paper. Y-axes should be used mark and label for counting data values (frequency values) and x-axis to mark and label with variable values from the histogram worksheet.

For using histogram, we need to use histogram worksheet to set up the histogram on graph paper. Histogram worksheet helps in determining the number of bars, the range of numbers that go into each bar and labels for the bar edge.

How you liked the write-up. Please post your comments. Thanks.

- Keshav Ram Singhal

Understanding Statistical Tools and Techniques - 06 - CONTROL CHART

CONTROL CHART

One of the key tools of Statistical Process Control (SPC) is a control chart. It is used to study and monitor a repetitive process, so that the process may remain in control.

Organizations use interrelated processes resulting output as a product. The outcome of a process is never exactly the same every time. Fluctuation or variability is an inevitable component of all processes or systems and it is expected. Fluctuation or variability arises naturally from the effects of miscellaneous chance events. If outcome of a process remains within the stable pattern, then we can say that the process is OK, but variation outside a stable pattern may be an indication that the process is not OK in a consistent manner. Event or outcome, finally beyond expected variability indicates that the process is out of control.



The control chart is a graph, which is used to show how a process changes over time. Data are plotted in time order. A control chart for a process has the following lines:

- A central line for the average
- An upper line for the upper control limit
- A lower line for the lower control limit

The values for the central line, upper line and lower line (i.e. control limits) are determined from historic data. These can be determined by computation based upon (i) the data covering past and current process records, (ii) statistical formulae whose reliability has been proved in practice. By comparing current data to these lines in the graph, one can come to the conclusion whether the process is in control or out of control. There are various types of control charts, divided in two groups – (i) Control chart for variables, and (ii) Control chart for attributes.



A control chart can be used:

- To control ongoing process by finding and correcting problems as they occur
- To predict the expected range of outcome from a process
- To determine whether a process is stable
- To analyze patterns of a process variations from special causes or common causes
- To determine whether improvement initiatives should aim to prevent specific problem or make changes to the process

Following procedure will be useful:

- Select the process that you wish to study, monitor or control
- Define the process control chart with average central line, upper control limit line and lower control limit line
- Determine the appropriate time period for collecting and plotting data
- Collect data and construct the control chart graph by plotting the data on the chart
- Analyze the graph, identify those signals which are ‘out-of-control’ on the chart and mark them on the graph
- Investigate the cause
- Document investigation process mentioning how investigated, what are the causes, what needs to be done to correct the ‘out-f-control’ situation

Standard control limits are located at 3-sigma away from the average or central line of the chart, known as 3-sigma limits. Control limits define a zone where observed data for a stable and consistent process occurs virtually all the time – 99.7%. Any fluctuations within these limits come from the common causes inherent to the process. Any fluctuations beyond the control limits results from a special cause that require fundamental change or improvement in the process. Any fluctuations beyond the control limits show that the process is out-of-control. When fluctuations are noticed beyond control limits then it is required to investigate and eliminate the special cause. Thus control chart can be used as a quality-monitoring tool.

How you liked the write-up. Please post your comments. Thanks.

- Keshav Ram Singhal

Understanding Statistical Tools and Techniques - 05 - CHECK SHEET

CHECK SHEET

A check sheet is an organized way of collecting and structuring data. This is a generic tool that can be used for a wide variety of purposes. With the use of this tool, we can collect the facts in a most efficient way. Data is collected and ordered (organized) by adding tally or check marks against predetermined categories of items or measurements. A check sheet simplifies the task of analysis.



A check sheet should be used:
- When data can be observed and collected repeatedly by a particular person or at a particular place
- When collecting data relates to frequency or pattern of events, problems, defects, defect location, defect causes etc.
- When collecting data relates to a particular production process

Following procedure will be useful:
- Define the event or problem to be observed
- Develop operational definitions
- Decide the time and duration of data collection
- Design the check sheet form in such a way that data can be recorded simply by marking check marks or Xs or other similar symbols. The design of check sheet form should make use of input from those who will actually use the check sheet.
- On the fixed time and duration, collect and record data on the check sheet.



A check sheet should be developed in such a way that it is easy to understand. A check sheet is a simple chart for gathering data. When check sheet is designed clearly and cleanly, it assist in gathering accurate and pertinent data, and also allow person concern to read and use data easily.

A check sheet can be kept electronically.

How you liked the write-up. Please post your comments. Thanks.

- Keshav Ram Singhal

Understanding Statistical Tools and Techniques - 04 - CAUSE AND EFFECT DIAGRAM

CAUSE AND EFFECT DIAGRAM

Kaoru Ishikawa developed this analysis tool in 1943. This diagram is also known as ‘Ishikawa diagram’ or ‘Fishbone diagram’.

The cause and effect diagram organizes and displays the relationship between different causes for the effect that is being examined. It is a useful tool for opening up thinking in problem solving. It identifies many possible causes for an effect or a problem. This tool can be used to structure a brainstorming session. In fact, the cause and effect diagram helps in organizing the brainstorming process in a systematic way. This is a tool that sorts ideas into different categories.




This tool should be used when you wish to identify possible causes for a problem. Following procedure will be useful:

- Identify the problem on which you wish to draw cause and effect diagram
- Write the problem at the centre right of the writing-board. Draw a box around it and draw a left-side horizontal line running to it.
- Brainstorm the main categories of causes, factors or concerns related to the problem. If you feel difficulty in grouping major categories, then it is better to use generic headings, such as Methods, Machine (equipment), People (human resource), Material, Measurement and Environment. These are commonly identified causes of problems.
- Write the categories of the causes, factors or concerns of the problem as the branches from the main row
- Brainstorm all the possible causes, factors or concerns of the problem. Ask – “Why?”
- Write the generated idea as a branch from the appropriate category. Possible causes, factors or concerns can be written in several places, if they relate to several categories. Example – No internal audit organized in the organization as the trained internal auditor resigned two months back. It can be written along People as well as along measurement.
- Again ask – “Why?” question about each cause. Continue asking – “Why? Why? Why?” and in this way you can generate deeper levels of causes, factors or concerns related to the problem.
- When you are unable to find more ideas, then focus your attention to the diagram where ideas are less.

Brainstorming can be effectively used to generate causes and sub-causes. When completed cause and effect diagram looks like a tree-like structure that indicates many factors including causes and concerns of a problem.

In this way you can now evaluate different causes, factors and concerns to solve a problem.

CAUSE AND EFFECT DIAGRAM WITH ADDITION OF CARDS

The process is similar as mentioned above, however, in the diagram at the cause side two different coloured cards are used to indicate facts in one colour card and ideas on other colour card. Generally facts are written on the left side of the cause spines, whereas ideas for solving the problem or effect are written on the right side of the cause spines. Ideas are then evaluated and selected to solve the problem or concern.

How you liked the write-up. Please post your comments. Thanks.

- Keshav Ram Singhal

Understanding Statistical Tools and Techniques - 03 - BRAINSTORMING

BRAINSTORMING

Brainstorming is an effective group technique, which can be used to generate a large number of ideas quickly. It can be an important part of identification process of risks and opportunities for applying risk-based thinking in a management system (such as ISO 9001:2015 QMS). The generated ideas can provide solutions to a specified problem in a variety of situations. In the process of brainstorming, members of the group are encouraged to put forward their ideas concerning the problem. All ideas generated in the group are recorded for subsequent analysis. Brainstorming technique may be formal and informal. Formal brainstorming is more structured.

Brainstorming cartoon – Courtesy www.socialsignal.com



Brainstorming process may be described as under:
- Identify a problem, for example determination of risks and opportunities in a particular process and proposed solutions.
- Call a brainstorming meeting of a group. Brainstorm as a group.
- Ask each member of the group to put forward their ideas.
- Record all ideas.
- Identify areas of improvements.
- Design solutions to the identified problem.
- Develop an action plan to execute designed solutions.

Brainstorming Image - Courtesy - www.mindspower.com



If you wish to generate a good number of ideas, then as convener of the brainstorming session, you should encourage all participants of the group to put forward their ideas. You should not criticize or make any adverse comments during the session. You should record all ideas. An openness of the convener will be able to bring out hidden ideas during the brainstorming session. A lot of good information and a number of ideas can be discovered, if the brainstorming team is a diverse and have experience in the identified problem area.

Brainstorming is generally used in conjunction with the cause and effect diagram tool. The cause and effect diagram identifies many possible causes for an effect or a problem. It can be used to structure a brainstorming session.

Thanks for the sources of Image and cartoon.

How you liked the write-up. Please post your comments. Thanks.

- Keshav Ram Singhal

Understanding Statistical Tools and Techniques - 02 - Problem Solving Approach 'DRIVE'

PROBLEM SOLVING APPROACH ‘DRIVE’

‘DRIVE’ is a problem solving methodology. It is an approach to problem solving and analysis that can help an organization to improve its processes.

The full form of ‘DRIVE’ is ‘Define-Review-Identify-Verify-Execute’. Using this methodology requires following steps:

D – Define – You should define – (i) the scope of your problem, (ii) the success criteria measurements – including deliverables and success factors that you agree

R – Review – Review the current situation of the problem, understand the background of the problem, determine and collect information – performance data, problem areas, improvement options

I – Identify (determine) – Identify (determine) improvement options or solutions to the problem – What changes you need to improve your process so as to enable to rectify the problem

V- Verify – Verify (check) – Whether determined improvement options or solutions will bring those results that we defined as the success criteria measurements

E – Execute (implement) for solutions and improvement – Plan and execute improvement options or solutions, check the results.

We are a quoting a simple example using ‘DRIVE’ methodology. In a class, when result of first assessment test announced, the management was worried looking to the result that 50 percent students failed in Mathematics, while in other subject the result was 95 to 100 percent. The school management used the problem solving approach ‘DRIVE’.

Define – Scope of the problem – 50 percent students failed in Mathematics. Success criteria – 95 percent students should get good marks in Mathematics.

Review – Current situation – Students of the class are good in other subjects. They could not get good marks in Mathematics. Background – The mathematics teacher resigned in the month of July and the Mathematics class is taken by other subject teacher. There is a shortage of Mathematics subject teachers in the school. School requires three Mathematics subject teachers, while there are two only. Problem area – Recruitment process requires advertisement in local newspapers and then selection of qualified teacher. No action yet initiated. Improvement option – Immediate action to start recruitment process

Identify – Identify (determine) – the recruitment procedure with timeframe objective and also during the time gap outsource Mathematics teacher from other schools and also plan taking extra periods on Sunday with the help of two Mathematics teachers available in the school on payment of extra remuneration.

Verify – Verified shortage of teachers and found improvement options suitable to solving the problem.

Execute – The school management took immediate steps to contact nearby schools and one school agreed to depute their one Mathematics teacher for one month. Extra classes were organized on Sunday with the help of two teachers. Recruitment process started and within one month a new Mathematics teachers recruited.

Thus the school management is able to improve its processes by using a problem solving approach ‘DRIVE’.

How you liked the write-up. Please post your comments. Thanks.

- Keshav Ram Singhal

Understanding Statistical Tools and Techniques – 01

Understanding Statistical Tools and Techniques – 01


Implementing an effective quality management system requires performance evaluation that includes monitoring, measurement, analysis and evaluation. Clause 9.1.3 of ISO 9001:2015 QMS Standard requires analysis and evaluation of appropriate data and information arising from monitoring and measurement. Methods to analyse data can include statistical tools and techniques. There are a number of statistical tools and techniques available for monitoring, measuring, analyzing and evaluating the organization’s processes. We are starting a series of articles under the heading ‘Understanding Statistical Tools and Techniques’. Some of the tools and techniques are as under:

- Problem solving approach ‘DRIVE’
- Brainstorming
- Cause and effect diagram – CED – Fishbone diagram – Ishikawa diagram
- Cause and effect diagram with addition of cards – CEDAC
- Check sheet
- Control chart
- Histogram
- Pareto analysis
- Scatter diagram
- Stratification
- Process mapping
- Process flowcharting
- Force field analysis
- Bar chart
- Matrix analysis
- Tally chart

The use of statistical techniques helps organization in understanding variability. It helps organizations to solve problems. It also helps organization to improve effectiveness and efficiency. The statistical techniques also facilitate better use of available data to assist in decision making. Seven tools from the above are known as basic quality tools. These are:
- Cause and effect diagram – CED – Fishbone diagram – Ishikawa diagram
- Check sheet
- Control chart
- Histogram
- Pareto chart
- Scatter diagram
- Stratification



Relevant requirements of ISO 9001:2015 QMS Standard (Clause 9.1) are summarized as under:

"Determine - (i) Monitoring and measurement needs, (ii) Monitoring, measurement, analysis and evaluation methods (Purpose - To ensure valid results), (iii) When to perform monitoring and measurement, (iv) When to analyze and evaluate the monitoring/measurement results, (v) Methods (such as using customer survey, customer feedback, customer meeting, market-share analysis, compliments, warranty claims, dealer report) for obtaining, monitoring and reviewing customers' perception information

Monitor/review/analyze/evaluate - (i) QMS performance and effectiveness, (ii) Customers' perception information.

Analyze and evaluate - (i) Monitoring/measurement data/information.

Use analysis results and evaluate - (i) Product/service conformity, (ii) customer satisfaction, (iii) QMS performance and effectiveness, (iv) Planning implementation effectiveness, (v) Actions effectiveness to address risks and opportunities, (vi) External providers performance, (vii) QMS improvement needs

Retain documented information - Evidence of monitoring / measurement / analysis / evaluation results.

Clarification - Statistical technique can be a method to analyze data."



To improve organization’s processes by means of a systematic approach, people working in the organization require the knowledge of simple kit of statistical tools and techniques. The person who actually works on the processes needs to understand these tools and techniques, so that he can effectively use these tools and techniques. Some may think that these tools are complex and require higher knowledge of Mathematics or Statistics. However, we will make the study of these tools and techniques in a language easy to understand. We request our readers to please send/post your comments. Short-term training 'Understanding Statistical Tools and Techniques' can be organized in your organization.

Hope the readers would find the series of articles interesting and useful.

- Keshav Ram Singhal

ISO 9001:2015 QMS - Creating and updating Documented information - Part 2

ISO 9001:2015 QMS - Creating and updating Documented information - Part 2

Developing documented information

Responsibility for development of documented information should be defined. These documented information may include scope of the quality management system, quality policy, quality objectives, information to support the operation of organization's processes, operational planning and control, characteristics of products/services, activities to be performed and results to be achieved and the determined documented information being necessary for the effectiveness of the organization's quality management system (including documented procedures, work instructions, forms etc.) and necessary records Performa. Defining the responsibility will lead to better understanding of necessary requirements. It will also provide a sense of responsibility, including the sense of involvement and ownership by personnel.

It is suggested that a task force with someone as its coordinator should be set up for developing the documented information. Initial training may also be necessary on developing documented information. Developing documented information is the most important activity in the implementation process. A list of documented information to be developed should be drawn up and the responsibility for writing the documented information should be assigned to persons concerned in various functional departments. Responsibility to develop documented information (for example: procedures, work instructions) should be given to those persons, who are involved with the processes and activities. This will lead to ownership of documented information and better understanding of the processes and related activities.

Documented information may be any type of media, such as hard copy or electronic media. Presently there is an increasing trend of using electronic media. The reasons are many including the following:
- Appropriate persons may have access to the documented information with up-to-date information all times.
- Access to documented information may be easily made and controlled.
- Necessary changes to the documented information and entry of relevant data in the documented information may be easily made and controlled.
- Distribution of electronic documented information is fast.
- Option of printing documented information as hard copies is possible.
- Electronic version of documented information can be accessed from remote locations.
- It is easy, simple and effective to withdraw obsolete documented information.

Quality manual (or QMS manual, description book or instructions manual)

The primary purpose of Quality manual (QMS manual, description book or instructions manual) is to provide an adequate description of the quality management system and to serve as a permanent guide to the implementation and maintenance of that system. A Quality manual (or QMS manual, description book or instruction manual) may be unique to each organization. Clause 3.8.8 of ISO 9000:2015, Quality management systems - Fundamentals and vocabulary, defines 'quality manual' as 'specification (document stating requirements) for the quality management system of an organization'. Quality manual of one organization can vary from other organizations in detail and format to suit the size and complexity of an individual organization.

A small organization may have the description of its entire quality management system within a single manual. Large organizations may need several manuals and more complex hierarchy of documented information.

Looking to the requirements of ISO 9001:2015 QMS standard, a Quality manual (QMS manual, description book or instructions manual) may contain the following:
- Scope of the organization's quality management system (4.3)
- Information to support the operation of organization's processes (4.4.2)
- Quality policy (5.2)
- Quality objectives (6.2.1)
- Operational planning and control (8.1)
- Documented information that defines the characteristics of the products and services to be produced/provided, activities to be performed, and the results to be achieved (8.5.1)
- Determined documented information (to maintain) as being necessary for the effectiveness of the organization's quality management system. (7.5.1)

The Quality manual (QMS manual, description book or instructions manual) normally contains the following:
- Title and scope - such as name of the organization and reference of the standard
- Table of contents
- Scope of the quality management system (boundaries and applicability including justification if any requirements of the standard is not applicable to the scope of the organization's quality management system)
- Issue number
- Date of issue
- Amendment record
- Evidence of review, approval and revision status
- Quality policy
- Quality objectives
- Organization's structure
- Organizational roles, responsibilities and authorities
- Flow chart of activities
- Description of applicable elements of the QMS including operational planning and control, characteristics of products and services to be produced/provided, activities to be performed, results to be achieved and other details as being necessary.
- References - List of documented information
- Definition section including vocabulary and terms
- An appendices showing supporting documented information, if appropriate.

The coordinator of the task force is normally the person who coordinates the activity of developing the Quality manual (QMS manual, description book or instructions manual) and other related documented information. Following steps may be useful for the preparation of the Quality manual (QMS manual, description book or instructions manual):
- The coordinator should make a list of all existing quality-related documented information and he/she should obtain copy of each documented information for reference.
- The coordinator should study each process and prepare a flow chart of activities.
- The coordinator should examine interfaces and lack of interfaces between the processes.
- The coordinator should review the process flow charts and identify duplication or omissions in the information or process flow.
- The coordinator should map out what is to be written in the Quality manual (QMS manual, description book or instructions manual).
- The coordinator should verify the presence of all the required elements of ISO 9001:2015 QMS in the current system.
- The coordinator should allocate responsibilities for preparing drafts of relevant parts of the Quality manual (QMS manual, description book or instructions manual) to the persons actually concerned with specific operations.
- It is always better to first deal with documented information covering critical areas and thereafter deal with documents that can be prepared easily.
- The coordinator should circulate the completed drafts to persons concerned for comments.
- The coordinator should consider comments received and incorporate necessary corrections.
- The coordinator should take actions to prepare final manuscript of the Quality manual (QMS manual, description book or instructions manual).

There are two approaches to write the Quality manual (QMS manual, description book or instructions manual):
- The first approach is to write the Quality manual (QMS manual, description book or instructions manual) according to the sequence and layout of the standard.
- The second approach is to write the Quality manual (QMS manual, description book or instructions manual) according to the organization work flow. Under this approach, cross-references are given in a schedule of conformity to the relevant clauses of the standard.

The first approach is generally used for writing the Quality manual (QMS manual, description book or instructions manual) by most organizations, particularly small and medium sized organizations, as it has advantage of making it easy to establish concordance with the requirements of the standard. The second approach is practical for large organizations.

Procedures

Clause 3.4.5 of ISO 9000:2015, Quality management systems - Fundamentals and vocabulary, defines 'procedure' as 'specified way to carry out an activity or a process (set of interrelated or interacting activities)'. A procedure can be a documented or not. When a procedure is documented, it is usually referred to as a 'written procedure' or 'documented procedure', which is a documented information.

A documented procedure usually covers the following:
- Title
- Document number
- Reference
- Cross-reference
- Purpose
- Scope
- Responsibility and authority
- Description of activities - Procedures (what, when, where, how, etc.), process controls, defining necessary resources, defining input and output of the process, defining measurements etc.
- Documented information to be retained related to the activities
- Appendices - Information supportive to the activities
- Review, approval and revision status
- Identification of changes

ISO 9001:2015 QMS standard does not specify specific mandatory documented procedures, however it is suggested that organization should determine procedures that the organization consider necessary for the effectiveness of the organization's quality management system. A list of suggested procedures can be as under:
- Determining context of the organization (4.1)
- Determining Interested parties (4.2)
- Addressing risks and opportunities (6.1)
- Determining resources (7.1) and monitoring and measuring resources (7.1.5)
- Determining competence (7.2)
- Creating and updating documented information (7.5.2)
- Control of documented information (7.5.3)
- Operational planning and control (8.1)
- Determining and reviewing requirements for products / services (8.2)
- Design and development of products / services (8.3)
- Control of externally provided processes / products / services (8.4)
- Production and service provision (8.5)
- Control of nonconforming output (8.7)
- Measuring customer satisfaction (9.1)
- Internal audit (9.2)
- Management review (9.3)
- Nonconformity and corrective action (10.2)

The following steps for developing procedures may be useful:
- The coordinator of the task force should determine the need.
- The coordinator should identify the person concerned to write the procedure.
- The coordinator should authorize the person concern to develop specific procedure(s).
- The person concerned should collect relevant information about the procedure.
- The person concerned should prepare a draft procedure and should handover to the coordinator.
- The coordinator should circulate the draft procedure to relevant persons in the organization who deal with the activity/process. He/she should obtain comments on the draft procedure and incorporate necessary changes.

Work Instructions

Work Instructions (WI) should be developed and maintained to describe the job correctly. Work instructions ensure processes to be consistent, timely and repeatable. A work instruction is a tool that provides the worker to do a job correctly. Performance of job would be adversely affected by lack of such work instructions. The structure, format and level of detail used in the 'Work Instructions' should be according to the needs of the organization and its people, and should depend on the complexity of the work, methods used and the competence of the people of the organization. Work instructions should describe critical activities.

The structure of work instructions may vary from that of documented procedures. However, work instructions should include the following:
- Title
- Unique identification
- Contents - Description of critical activities
- Purpose, scope and objectives approval
- Reference to the pertinent documented procedures
- Review, approval and revision status
- Documented information to be retained (records), where applicable
- Identification of changes, where practicable - the nature of changes identified either in the document or the appropriate attachment

Following steps for developing work instructions may be useful:
- The coordinator of the task force or the department head should identify the need of work instructions.
- The coordinator of the task force or the department head should identify the person concerned to write the work instructions.
- The coordinator of the task force or the department head should authorize the person concerned to develop specific work instructions.
- The person concerned should collect relevant information about the work instructions.
- The person concerned should prepare a draft work instructions and should handover the same to the coordinator of the task force or the department head.
- The coordinator of the task force or the department head should circulate the draft work instructions to persons handling/supervising the work, then should obtain comments on the draft work instructions and incorporate necessary changes.

Forms

Forms are created to fill a business need and to collect relevant data. It should be ensured that forms should not be boring and painful. It should be easy to use, collects what is necessary, and can sometimes enhance the process or activity it belongs to. Efforts should be made to develop forms that are clear and concise. The form should contain the following:
- Title
- Identification number
- Revision level and date of revision
- Contents - To collect relevant

Quality Plan

Clause 3.8.9 of ISO 9000:2015, Quality management system - Fundamentals and vocabulary, defines 'quality plan' as 'specification (document stating requirements) of the procedures (specified way to carried out an activity or a process) and associated resources to be applied when and by whom to a specific object (entity, item or anything perceivable or conceivable, such as a product, service, process, person, organization, system, resource).' Quality plan procedures generally include procedures referring to quality management system processes and operation related processes. A quality plan often makes reference to parts of the Quality manual (QMS manual, description book or instructions manual) or to documented procedures. A quality plan is generally one of the results of quality planning. Thus, a quality plan should contain scope, unique procedures, work instructions and/or documented information to be retained (records).

Approval of Documented Information

After developing a particular documented information, appropriate steps regarding approval of the documented information should be taken to ensure appropriate approval for suitability and adequacy.

- Keshav Ram Singhal


For details on the Training Handbook on 'ISO 9001:2015 QMS Awareness', please CLICK HERE.

For details on 'Checklist for ISO 9001:2015 QMS', please CLICK HERE.

ISO 9001:2015 QMS - Creating and updating Documented information - Part 1

ISO 9001:2015 QMS - Creating and updating Documented information - Part 1

Documented information in ISO 9001:2015 QMS

ISO 9001:2015 QMS standard does not specify any particular format or design for documented information to maintain and to retain. Earlier version ISO 9001:2008 QMS standard used the terms 'documents', 'documented procedure', 'quality manual' and 'quality plan', however these terms are not used in the requirements of ISO 9001:2015 QMS standard, instead a new term 'documented information' has been used in ISO 9001:2015 QMS standard requirements. Clause 3.8.6 of ISO 9000:2015, QMS - Fundamentals and vocabulary, defines the term 'documented information' as an information (meaningful data) required to be controlled and maintained by the organization and the medium on which it is contained. Documented information can be in any format. It can be in any media. It can be from any source. However, Annex A of ISO 9001:2015 QMS standard provides freedom to organizations to use terms which suit their operations, such as 'records', 'documentation' or 'protocols' rather than 'documented information'. Accordingly, organizations can use the terms 'documentation', 'quality manual', 'QMS manual', 'documented procedures', 'records', 'quality plan' that suit them.

ISO 9001:2015 QMS standard has used two types of terms: 'maintain documented information' and 'retain documented information'. The term 'maintain documented information' is equivalent to keeping a 'document', or 'documented procedure', 'quality manual' or 'quality plan'. The term 'retain documented information' is equivalent to keeping records. In this connection Para A.6 of Annex a of ISO 9001:2015 QMS standard should be referred to.

As per the provisions of ISO 9001:2015 QMS standard (reference Clause 7.5.1), the organization's quality management system documentation need to include the following:
- Documented information required by ISO 9001:2015 QMS standard, and
- Documented information determined by the organization.

ISO 9001:2015 QMS standard requires: (i) to develop a quality policy, (ii) to establish quality objectives at relevant functions, levels and processes, (iii) to create, update, control and retain documented information (as mentioned in the standard and as determined by the organization as being necessary for the effectiveness of the organization's quality management system, and (iv) to maintain documented information to support the operation of its processes and retain them to have confidence that the processes are carried out as planned.

ISO 9001:2015 QMS standard requires to maintain following documented information:
- Scope of the organization's quality management system (4.3)
- Information to support the operation of organization's processes (4.4.2)
- Quality policy (5.2)
- Quality objectives (6.2.1)
- Operational planning and control (8.1)
- Documented information that defines the characteristics of the products and services to be produced/provided, activities to be performed, and the results to be achieved (8.5.1)
- In addition to the above, the organization should determine documented information (to maintain) as being necessary for the effectiveness of the organization's quality management system. (7.5.1)

ISO 9001:2015 QMS standard also requires to retain following documented information:
- Processes carried out as planned (4.4.2)
- Monitoring and measuring resources - evidence of fitness, and basis used for calibration and verification, where no international or national measurement standard exists (7.1.5)
- Evidence of competence (7.2)
- Operation planning and control (8.1)
- Results of the review of requirements, including any new or changed requirements, for the products and services, and where requirements for products and services are changed, amendment of relevant documented information (8.2.3)
- Confirmation that design and development requirements are met (8.3.2)
- Design and development inputs (8.3.3)
- Design and development controls activities (8.3.4)
- Design and development outputs(8.3.5)
- Design and development changes, results of reviews, authorization of changes, and actions taken to prevent adverse impacts (8.3.6)
- Evaluation, selection, monitoring of performance, and re-evaluation activities of external providers and any necessary actions (8.4.1)
- Necessary information to maintain traceability (8.5.2)
- Information regarding property belonging to customers or external provider is lost, damaged or otherwise found to be unsuitable for use and reporting to the customer or external provider (8.5.3)
- Results of the review of changes, personnel authorizing the changes, and any necessary action (8.5.6)
- Evidence of product/service conformity with the accepted criteria (8.6)
- Traceability to the person(s) authorizing release of products and services for delivering to the customer (8.6)
- Release of product/service including evidence of conformity with acceptance criteria, Information that describes nonconformity, the actions taken, any concession obtained, and that identifies the authority deciding the action (8.7.2)
- Evidence of results in monitoring, measurement, analysis and evaluation (9.1.1)
- Evidence of the implementation of the internal audit programme, and internal audit results (9.2)
- Evidence of the results of management review (9.3)
- Evidence of nature of nonconformities and subsequent actions, and results of any corrective action (10.2)
- In addition to the above, the organization should determine documented information (to retain) as being necessary for the effectiveness of the organization's quality management system. (7.5.1)

Structure of documented information

QMS documented information is the basis for establishing, implementing and maintaining a quality management system in an organization. ISO 9001:2015 QMS standard does not specify any particular format or design for documented information to maintain and to retain, however most organizations prefer to opt for three-levels documented information, which are as under:

- Level 'A' Documented Information: Consisting of Quality Policy, Quality Objectives and Quality Manual (or QMS Manual).
- Level 'B' Documented Information: Consisting of documented information that are required to maintained, such as documented procedures, work instructions.
- Level 'C' Documented Information: Consisting of documented information that are required to retained by the organization, such as records, and others that are needed by the organization, such as various forms, standards, drawings, specifications, etc.

It is not necessary for an organization to have three levels of documented information separately. An organization can combine Level 'A' and Level 'B' documented information in one manual or can have separate manual for different documented information. QMS documented information of one organization can differ from the other due to the following reasons:
- The size of an organization may differ from the size of other organization.
- The type of activities of an organization may be different from the activities of other organization.
- The products/services of an organization may be different from the products/services of other organization.
- The complexity of processes and their interactions of an organization may be different from the complexity of processes and their interactions of other organization.
- The competence of personnel of an organization may differ from the competence of personnel of other organization.

Purposes and Benefits of Documented Information

There are several purposes and benefits of having documented information in the quality management system. Documented information generally serves the following purposes:
- Documented information in the quality management system establishes that the organization is dependent on the system, and not on person.
- Documented information in the quality management system describes the quality management system of the organization.
- Documented information in the quality management system provides evidence of management commitment to the system.
- Documented information in the quality management system provides an invaluable training aid to its employees. It defines and guides how the quality management system is managed in the organization. It provides a basis for training new employees and periodic re-training of current employees.
- Documented information in the quality management system assists employees to carry out their jobs effectively by removing ambiguities, defining the system, allocating responsibilities and authorities and identifying those responsible for the activities. It helps employees to understand their roles within the organization.
- Documented information in the quality management system provides mutual understanding between employees and management.
- Documented information in the quality management system provides results of periodic audit and management review.
- Documented information in the quality management system provides operational planning and control guidelines.
- Documented information in the quality management system demonstrates to the organization's customers, certification body and interested parties that the quality management system has been systematically planned.
- Documented information in the quality management system defines the characteristics of the products/services to be produced/provided, activities to be performed, and the results to be achieved that form basis for expectation of work performance.

Is quality manual required in ISO 9001:2015 QMS?

ISO 9001:2015 QMS standard no longer includes the requirement of a documented quality manual, where ISO 9001:2008 QMS standard requires a documented quality manual. Although there is no explicit requirement for the quality manual in ISO 9001:2015 QMS standard, however its clause 7.5.1 (b) states to include documented information determined by the organization as being necessary for the effectiveness of the quality management system. Accordingly, most organizations would determine a Quality manual (or QMS manual, description book or instructions manual) that may define and provide clear direction to the organization's people regarding implementing ISO 9001:2015 QMS in the organization.

- Keshav Ram Singhal

... To be continued


For details on the Training Handbook on 'ISO 9001:2015 QMS Awareness', please CLICK HERE.

For details on 'Checklist for ISO 9001:2015 QMS', please CLICK HERE.

Quality Concepts and ISO 9001:2008 QMS Awareness: My organization wishes to move from ISO 9001:2008 ...

Quality Concepts and ISO 9001:2008 QMS Awareness: My organization wishes to move from ISO 9001:2008 ...: My organization wishes to move from ISO 9001:2008 to ISO 9001:2015. What to do? As you know, ISO 9001:2015 QMS standard has replaced the...

ISO 9001:2015 QMS - QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM

ISO 9001:2015 QMS - QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM



As per the requirements of ISO 9001:2015 QMS standard, the organization is required to establish (set up, install or create) quality objectives at relevant functions, levels and processes, and such objectives must consider applicable requirements and must also be: (i) consistent with the quality policy, (ii) measurable, (iii) relevant to conformity of products and services, (iv) relevant to the enhancement of customer satisfaction, (v) monitored, (vi) communicated, and (vii) updated, as appropriate. The organization is also required to retain documented information on quality objectives.

As per requirements of ISO 9001:2015 QMS standard, to achieve the quality objectives, the organization is required to determine:
- ways, procedures or processes,
- resources needed,
- responsible personnel,
- completion time,
- ways, procedures or processes to evaluate results.

Quality objectives are the basis of improvement and growth of the organization. Quality objectives must be in line with the quality policy of the organization. These should be measurable, so that organization's performance can be evaluated. The quality objectives must be appropriate or closely connected to conformity of products and services and also to the customer satisfaction enhancement. The organization must observe and check the progress of quality objectives over a period of time. There must be a systematic review of quality objectives and updated, as appropriate. Quality objectives must be communicated within the organization, so that the responsible personnel can take appropriate actions. It would be better if SMART (Specific, Measurable, Achievable, Realistic and Time-bound) quality objectives are set and regularly monitored. An organization can define in process monitoring and output measures.

In this regard, following action plan can be useful:
- Establish quality objectives at relevant functions, levels and processes
- Ensure that quality objectives are consistent with quality policy, measurable and relevant to conformity of products and services as well as to the customer satisfaction
- Determine ways, procedures or processes to achieve the quality objectives, resource needs, responsible personnel, completion time and procedures to evaluate results
- Communicate within the organization established quality objectives, monitoring and evaluating methods
- Update, as appropriate, quality objectives from time to time
- Monitor and evaluate quality objectives as per determined procedure

- Keshav Ram Singhal