A New Standard for "Quality Management - Guidance for People Engagement" Published In April 2020

A New Standard for "Quality Management - Guidance for People Engagement" Published In April 2020

International Organization for Standardization (ISO) has published a new standard ISO 10018:2020, Quality management - Guidance for people engagement in April 2020.

Are you looking for the latest on employee engagement practices? There is no need to look further, just see newly published ISO 18011:2020 standard that provides guidance for people engagement. The arrival of ISO 10018:2020 standard promises to shake up the marketplace – even for the most innovative of organizations. Organizations may learn ways to engage people in their quality management system and enhance their involvement and competence within it.

People engagement is the emotional commitment that people have to the organization and its goals. This commitment means engaged people actually care about their work and their organization. They don’t work for just a pay cheque, or just for the next promotion, but invest their energies towards the organization’s goals. This is where ISO 10018 can make a difference.

ISO 10018:2020, Quality management – Guidance for people engagement is a newly published standard. It recognizes that it can be difficult encouraging staff to take up quality management systems and understand how they are relevant to their daily work. By focusing on better integration of engagement strategies, the standard provides a framework to enhance people’s involvement and competence within an organization, helping them to feel a valued part of it. This standard provides the practical tips for employee engagement.

The new standard complements ISO 10015:2019, Quality management – Guidelines for competence management and people development, explains John J. Guzik, Convenor of the joint working group for guidance on people involvement and engagement (ISO/TC 176/SC 3/JWG 21). Both International Standards present practical steps for managers and leaders to follow, adopt and measure.

Staff competence and development should be a collective aspect of the organization and not just for specific individuals, Guzik points out. People need to see the connection between their current work and how further training can provide more opportunities within the organization. “If they see that their organization is investing in their skills through training and other career tracks, they will feel engaged."

Aimed at bringing quality management principles down to staff level, the standard is designed to be regularly referred to and not simply handed to employees in binders and then left to gather dust on the shelf.

ISO 10018:2020 document provides guidelines for engaging people in an organization’s quality management system and on enhancing their involvement and competence within it. This document is applicable to any organization, regardless of its size, type or activity.

Contents of ISO 10018:2020 are as under:

Foreword
Introduction

1. Scope

2. Normative references

3. Terms and definitions

4. Context of organization and quality culture
4.1 - Considerations
4.2 - Link to ISO 9001 and other quality management standards
4.3 - Possible action steps
4.4 - Potential benefits

5. Leadership
5.1 - Considerations
5.2 - Link to ISO 9001 and other quality management standards
5.3 - Possible action steps
5.4 - Potential benefits

6. - Planning and strategy
6.1 - Considerations
6.2 - Link to ISO 9001 and other quality management standards
6.3 - Possible action steps
6.4 - Potential benefits

7. - Knowledge and awareness
7.1 - Considerations
7.2 - Link to ISO 9001 and other quality management standards
7.3 - Possible action steps
7.4 - Potential benefits

8. - Competence
8.1 - Considerations
8.2 - Link to ISO 9001 and other quality management standards
8.3 - Possible action steps
8.4 - Potential benefits

9. - Improvement
9.1 - Considerations
9.2 - Link to ISO 9001 and other quality management standards
9.3 - Possible action steps
9.4 - Potential benefits

Bibliography


Please note that paper format of the standard is currently unavailable and ePublication in pdf format is available, which is priced CHF 58. ISO 10018:2020 standard developed by technical committee ISO/TC 176, Quality management and quality assurance, subcommittee SC 3, Supporting technologies, the secretariat of which is held by NEN, ISO’s member for the Netherlands. It is available from the national ISO member or through the ISO Store. Bureau of Indian Standards (BIS) is the national ISO member in India.

(Courtesy - ISO website)

Best wishes,
Keshav Ram Singhal

Second Batch of Free Online Training on 'ISO 9001:2015 QMS Awareness'

Second Batch of Free Online Training on 'ISO 9001:2015 QMS Awareness'

Dear friend,

Greetings.

I am glad to announce Second Batch of Free Online Training on ISO 9001:2015 QMS Awareness.

We are, in India, presently under lock down period and will stay at home up to 14th April 2020 to fight against Corona virus disease and prevent its infection. I am 69 years old person having interest in reading, writing, learning etc. To keep busy during these days, I have decided to conduct Second Batch of Free Online Training on "ISO 9001:2015 QMS Awareness" starting from 10 April 2020. I append below some details about the online training.

Learning objectives

After attending the training, a participant will be able to understand KEY CHANGES that affect an organization and its quality management system implementation, including the following -
- Structure and terminology
- Context of the organization
- Risk-based thinking
- Organizational knowledge
- Role of top management
- Management representative's role?
- Documentation impact and requirements for documented information
- Internal audit requirements
- Understanding ISO 9001:2015 QMS requirements
- Planning guidance
- Implementation guidance
- Quality management principles
- Change management
- Adding value to the audit

Contents of the training

First Set
# 01 - Learning objectives
# 02 - Historical background
# 03 - Standard development timeline for ISO 9001:2015
# 04 - Why new version?
# 05 - Key feature changes

Second Set
# 06 - Structure and terminology
# 07 - Meaning of certain terms
# 08 - Foreword of the standard
# 09 - Introduction
# 10 - ISO 9001:2015 clauses in brief

Third Set
# 11 - Context of the organization
# 12 - Leadership
# 13 - Management representative in ISO 9001:2015 QMS?
# 14 - Planning
# 15 - Support

Fourth Set
# 16 - Operation
# 17 - Performance evaluation
# 18 - Improvement
# 19 - Tips for organizations using ISO 9001:2008
# 20 - Transition period
# 21 - Developing and implementing ISO 9001:2015 QMS

Fifth Set
# 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

Sixth Set
# 27 - Evaluation questionnaire, Feedback and Acknowledgement


Training material, communication and assignments will be sent by email and/or WhatsApp to the participant, who is enrolled for the training. Name of participants attending the training will be posted in this blog. Every participant is required to complete and send completed assignments to the trainer as early as possible so as to complete all assignments on or before 14 April 2020.

Target participants

Working management executive, academician, auditor and person (residing in India) interested in learning ISO 9001:2015 QMS and wish to update his / her knowledge.


How to enroll?

If you are interested to attend the online training, please send an email to krsinghal@rediffmail.com or keshavsinghalajmer@gmail.com on or before 10th April 2020 by mentioning the subject line of the email as 'Enrollment for Second Batch - Online Training' with following details:
- Name,
- Occupation / Designation,
- Organization,
- Address,
- WhatsApp number,
- Email,
- How you come to know about this training?
- Have you attended any QMS training in the past?
- Any other information, you wish to communicate.

On receipt of your above information, training materials (including assignments) will be sent. It is expected from a participant to complete his / her assignments in time. Interaction with participants will be done through WhatsApp. On the basis of evaluation of assignments, the trainer will advise a participant successful in his/her attempt, if s/he scores 75% or more marks. Successful participant will get an appreciation communication from the trainer.

Your investment - Time for reading the training material and completing the assignments. Earlier batch participants took 7 to 10 hours period in reading and completing the assignments. No fee is being charged for this training.

Please share this information among others for their benefit.

Happy Learning. Best wishes,

Keshav Ram Singhal
Trainer
Please CLICK HERE for the trainer's profile.

Free Online Training on ISO 9001:2015 QMS Awareness

Free Online Training on ISO 9001:2015 QMS Awareness

Dear friend,

Greetings.

We are, in India, presently under lock down period and will stay at home up to 14th April 2020 to fight against Corona virus disease and prevent its infection. I am 69 years old person having interest in reading, writing, learning etc. To keep busy during these days, I have decided to conduct a Free Online Training on "ISO 9001:2015 QMS Awareness" during 1 -7 April 2020. I append below some details about the online training.

Learning objectives

After attending the training, a participant will be able to understand KEY CHANGES that affect an organization and its quality management system implementation, including the following -
- Structure and terminology
- Context of the organization
- Risk-based thinking
- Organizational knowledge
- Role of top management
- Management representative's role?
- Documentation impact and requirements for documented information
- Internal audit requirements
- Understanding ISO 9001:2015 QMS requirements
- Transition planning guidance
- Implementation guidance
- Quality management principles
- Change management
- Adding value to the audit

Contents of the training

# 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, Feedback and Acknowledgement


Training material, communication and assignments will be sent either by email or WhatsApp to the participant, who is enrolled for the training. Name of participants attending the training will be posted. Every participant is required to complete and send completed assignment to the trainer.

How to enroll?

If you are interested to attend the online training, please send following information by email to krsinghal@rediffmail.com on or before 3rd April 2020: Name, Occupation / Designation, Organization, Address, WhatsApp number, Email, How you come to know about this training? Have you attended any QMS training? Any other information, you wish to communicate.

On receipt of your above information, I will send learning material and assignments. On 6th April 2020, an evaluation questionnaire and feedback will be sent to the participant, which should be completed by the participant and sent it back to the trainer on or before 7th April 2020. Upon receipt of answers, the trainer will evaluate participant's answers and will advise the participant successful in his/her attempt, if the participant secures 75% or more marks. Successful participant will get an appreciation letter from the trainer.

Your investment - Time for reading the training material and completing the assignments. No fee is being charged for this training.

Please share this information among others for their benefit.

Happy Learning. Best wishes,

Keshav Ram Singhal
Trainer
Please CLICK HERE for the trainer's profile.

Applying Risk-based Thinking - Failure Modes and Effect Analysis (FMEA)

Applying Risk-based Thinking - Failure Modes and Effect Analysis (FMEA)

First question comes in our mind, how to use risk-based thinking in the QMS. Simple, we need to identify, understand and then address risks. ISO 9001:2015 QMS standard does not provide any specific procedure or method to determine risks and opportunities. It is for the organization to apply any procedure or method to determine risks and opportunities. Risk analysis is the important step of identify potential problems. One commonly used method of risk identification and risk analysis is known as 'Failure Modes and Effect Analysis' (FMEA) that is done during the design of a product or process. The purpose of FMEA is to identify all potential problems that could arise in the product or process, identify how critical is the risk and decide what to do about it. FMEA is a structured approach to discovering potential failures that may exist within the design of a product or process. Failure modes are the ways in which a process can fail. Effects are the ways that these failures can lead to waste, defects or harmful outcomes.



FMEA process includes four steps -

(i) Identify your risks - It can be done in a brainstorming from different areas of your organization. List all potential problems that could arise. Considering external and internal issues and interested parties (as determined as per clause 4.1 and 4.2 of the standard) will be helpful in identifying the risks.

(ii) Determine how critical each risk is - You should assess the risk against probability of occurrence, severity of occurrence and chance of detection of occurrence. Brainstorm each risk that you identify. What is the probability of risk occurring? What is its impact?

(iii) Rank the risk - You should decide the rank of the risk, whether the risk is acceptable or unacceptable. What is your priority with regard to the risk?

(iv) Determine actions - After understanding the risk, determine your actions, what should be done. What you plan? Plan actions to address the risks. Mention mitigation steps to eliminate or reduce the risks.

FMEA process is simple. It is easy to use. FMEA process gives results that are easy to determine acceptability, and thus provides a framework to assign resources to risk reduction that is easily supported. You should clearly understand that FMEA is a way of dealing risk analysis, and it is in no way mandated by ISO 9001:2015 QMS standard that you must use it. Any method you find useful, relevant and efficient can be used.

After FMEA process, you need to address the risk:
(i) Implement the plan - Take action
(ii) Check the effectiveness of the action
(iii) Improve your action on the basis of check results

Thanks,

Keshav Ram Singhal

Organizations may contact for conducting in-house training program on (i) 'ISO 9001:2015 QMS Awareness', and (ii) 'Applying risk-based thinking'.

Applying Risk-based Thinking - Checklist

Applying Risk-based Thinking - Checklist

A checklist is a list of things that can be checked off as completed or noted. When we certain steps to do for a work or process, we make a list of all of them and we check them off as we accomplish each of them. A checklist is a type of informational job aid used to reduce failure by compensating for potential limits of human memory and attention. It helps to ensure consistency and completeness in carrying out a task. Check-lists are simple form of risk identification technique that provides a listing of typical uncertainties which need to be considered. Check-lists are developed usually from experience - either from previous risk assessment result or from past failure result. A check-list can be used to determine hazards and risks. It can be used to assess the effectiveness of the controls applied. Check-lists can be used at all stages of the life cycle of a product/service or system. They may be used independently or as a part of other risk assessment techniques. A well designed check-lists may be used by non-experts and help ensure that common problems are taken care.

Typical daily checklist for boiler maintenance may be as under:

- Inspect around and under the boiler equipment for leaking water
- Ensure that the area around the boiler equipment is free of materials that may cause obstruction
- Check and ensure temperature readings are within the designed range
- Check and ensure pressure readings are within the designed range
- Watch closely all display panels and ensure no error codes or service codes
- On watching any error codes, ensure to send for service
- Ensure vent termination is not blocked or obstructed
- Inspect and ensure the combustion air opening with no blockage
- Always listen closely for any unusual noises or vibrations

To prepare a checklist for a particular process, make a small team of identified people who should be asked to prepare check points of the known issues that can affect conformity of the product/service (risks) and have the ability to enhance customer satisfaction (opportunities).

For writing of a checklist, the initial process is to carry out a thorough investigation of the task to accomplish. A good checklist starts with a thorough investigation into what and why of whatever it is you are trying to accomplish. Understand objectives of what you want to accomplish. Before you start making your checklist, you must understand what you want to accomplish. Do some research. Find out what others are doing. Write down all points. Get everything documented what you want to accomplish. Brainstorm on your own each point of the process and note down them. You must know the value of each task. Write down in simple language to include a fully detailed description by organizing all your points.

Thanks,

Keshav Ram Singhal

Organizations may contact for conducting in-house training program on (i) 'ISO 9001:2015 QMS Awareness', and (ii) 'Applying risk-based thinking'.

Applying Risk-based Thinking - Brainstorming Technique

Applying Risk-based Thinking - Brainstorming Technique

Please refer to the earlier article of this blog on 'Understanding Statistical Tools and Techniques - 03 - BRAINSTORMING'.

Thanks,

Keshav Ram Singhal

Organizations may contact for conducting in-house training program on (i) 'ISO 9001:2015 QMS Awareness', and (ii) 'Applying risk-based thinking'.

Applying Risk-based Thinking - Overview of risk assessment tools and techniques

Overview of risk assessment tools and techniques

For understanding a formal risk management following standards may be useful for your reference:
- ISO 31000:2018, Risk management - Guidelines
- ISO/TR 31004:2013, Risk management - Guidance for the implementation of ISO 31000
- IEC 31010:2019, Risk management - Risk assessment techniques

Every organization, whether it is small, medium or large, private or public, manufacturing or service, faces various factors and influences that may be internal and external. Internal and external factors and influences in an organization lead to uncertainty with regard to achievement of organization’s objectives. The effect of uncertainty on the organization’s objectives is termed as risk. Thus risk is an effect of uncertainty on objectives. An effect is a deviation from the expected. The effect may be positive and/or negative. To manage risk, an organization needs to carry out coordinated activities. Risk management is a process that is underpinned by a set of principles. Also it needs to be supported by a structure that should be appropriate to the organization, its environment and context. International Organization for Standardization (ISO) in 2009 has published an International Standard ISO 31000 that describes Risk management – Principles and guidelines, which has been revised and published in 2018 as Risk management - Guidelines. ISO 31000:2018 standard targets the quality of an organization’s management and suggests risk management frameworks, processes and activities that should be followed to help organizations better meet their goals and objectives. ISO 31000:2018 standard describes an overall approach to risk management, not just risk analysis or risk assessment. ISO 31000:2018 standard takes a general approach that can be developed. ISO 31000:2018 standard helps organizations develop a risk management strategy to effectively identify and mitigate risks, thereby enhancing the likelihood of achieving their objectives and increasing the protection
of their assets. Its overarching goal is to develop a risk management culture where employees and stakeholders are aware of the importance of monitoring and managing risk.

You can get the copy of standards from the national standards body in your country that is a member of ISO. In India, Bureau of Indian Standards (Website - http://bis.org.in/) is the national standards body, where you can get copies of standards.

There are various tools and techniques mentioned in ISO 31010:2018 standard that can be used for risk assessment. List of such a few tools and techniques are as under:
(i) Brainstorming
(ii) Structured or semi-structured interviews
(iii) Delphi
(iv) Check-lists
(v) Primary hazard analysis
(vi) Hazard and operability studies (HAZOP)
(vii) Hazard Analysis and Critical Control Points (HACCP)
(viii) Environmental Risk Assessment
(ix) Structured 'What If' Technique (SWIFT)
(x) Scenario analysis
(xi) Business impact analysis
(xii) Root cause analysis
(xiii) Failure mode effect analysis (FMEA)
(xiv) Fault tree analysis (FTA)
(xv) Event free analysis
(xvi) Cause and consequence analysis
(xvii) Cause and effect analysis
(xviii) Layers of protection analysis (LOPA)
(xix) Decision tree analysis
(xx) Human reliability analysis
(xxi) Bow tie analysis
(xxii) Reliability centred maintenance
(xxiii) Sneak circuit analysis
(xxiv) Markov analysis
(xxv) Monte Carlo simulation
(xxvi) Bayesian statistics and Bayes Nets
(xxvii) FN curves
(xxviii) Risk indices
(xxix) Consequence/probability matrix
(xxx) Cost/benefit analysis
(xxxi) Multi-criteria decision analysis (MCDA)

In forthcoming chapters, we will focus on a few tools and techniques that an organization may implement for addressing risks and opportunities in the organization.

There is no requirement in ISO 9001:2015 QMS standard for a formal risk management or a documented risk management process. The concept of preventive action is expressed in ISO 9001:2015 QMS standard through the risk-based thinking. Risk-based thinking should be applied in the cyclic process that should include:
- Indentify risks,
- Determine the severity of consequences,
- Evaluate likelihood of occurrence,
- Determine policy and action plan to deal with it it happens,
- Monitor and review .... and so on.

We will focus on a few tools and techniques in the forthcoming articles.

- Keshav Ram Singhal

Organizations may contact for conducting in-house training program on (i) 'ISO 9001:2015 QMS Awareness', and (ii) 'Applying risk-based thinking.'

Applying Risk-based Thinking - Planning and addressing risks and opportunities

Planning and addressing risks and opportunities

One of the major changes in the 2015 revision is to apply a systematic approach to risk. Thus, it requires applying a risk-based thinking. Although in the previous editions of ISO 9001 standards, a clause preventive action was always there, however now the planning and addressing risks and opportunities are part of the quality management system as a proactive approach. By applying a risk-based thinking in the system, an organization becomes proactive rather than reactive.

Clause 6 of ISO 9001:2015 QMS standard requires an organization to (i) determine risks and opportunities, (ii) plan actions to address risks and opportunities, and (iii) ensure actions taken (to address risks and opportunities) must be in proportionate to the potential impact on product/service conformity. In this connection the organization needs to plan: (i) ways to integrate and implement actions (to address risks and opportunities) into its quality management system, and (ii) methodology to evaluate the effectiveness of the actions taken.

So, planning of proposed actions should be adequate. Before planning processes that address risks and opportunities, you need to analyze the relative importance of risks and opportunities in your quality management system. Risks and opportunities should be evaluated using appropriate tools and techniques. When risk levels are high, appropriate risks reduction actions should be implemented and integrated into the quality management system. Risk reduction action should be proportionate to the potential impact on the conformity of product/service.

Some of the suggested actions may be:
- Regular (not one time) determination and analysis of internal and external issues
- Periodic analysis and review of QMS processes and resources
- Improvement of procedures and methodologies
- Analysis of all possible consequences of changes
- Improvement of leadership skills
- Determining required frequency of internal audits and management reviews
- Control of decisions implementation
- Monitoring of information on internal and external issues
- Monitoring of information on interested parties and their needs and expectations
- Monitoring of maintenance / repair schedule and its revision
- Improvement of people's competence and skills

Organizations can use risk assessment tools and techniques. In this training handbook, you will find overview of risk assessment tools and techniques, details of a few tools and techniques (such as, Brainstorming, Check-lists, FEMA, Delphi). A simple method to determine risks and opportunities is mentioned as well as a format is designed for this.

In short, determine and understand what your risks (and opportunities) are, plan actions to address your risks (and opportunities), so that you may avoid and eliminate your risks.

- Keshav Ram Singhal

Organizations may contact for conducting in-house training program on (i) 'ISO 9001:2015 QMS Awareness', and (ii) 'Applying risk-based thinking.'

Applying Risk-based Thinking - Interested parties and their needs and expectations - A few examples

Interested parties and their needs and expectations - A few examples

Sr. No. Interested party - External or internal - Needs and expectations
1. Customers - Internal - Timely delivery
2. Customers - Internal - Product as per specifications
3. Customers - External - Good quality
4. Customers - External - Timely delivery
5. Customers - External - Reasonable price
6. Owners, shareholders - Internal - Sustained profitability
7. Owners, shareholders - Internal - Transparency
8. Employees - Internal - Working environment suitable to job
9. Employees - Internal - Job security
10. Employees - Internal - Recognition and reward
11. Employees - Internal - Salary in time
12. Suppliers - External - Long-term relationship
13. Suppliers - External - Mutual benefits
14. Society, neighbour - External - Ethical behaviour
15. Society, neighbour - External - Pollution-free activities
16. Statutory and regulatory bodies - External - Compliance with statutory and regulatory requirements
17. Lending bank - External - Timely submission of stock statements, payment of installments

Above examples are illustrative. There may be more.

- Keshav Ram Singhal

Organizations may contact for conducting in-house training program on (i) 'ISO 9001:2015 QMS Awareness', and (ii) 'Applying risk-based thinking.'

Applying Risk-based Thinking - Understanding the needs and expectations of interested parties

Applying Risk-based Thinking - Understanding the needs and expectations of interested parties


Clause 4.2 of ISO 9001:2015 QMS standard deals with the requirements related to the understanding of the requirements of interested parties. According to the requirements of the standard, following needs to carry out:

(i) Determine: Interested parties relevant to the organization
(ii) Determine: Requirements of the determined interested parties that are relevant to the organization
(iii) Monitor and review: Information about the determined interested parties and their determined requirements.

Clarification:
(i) Interested parties = Persons/organizations that can affect, be affected by, or perceive themselves to be affected by a decision or activity.
(ii) Examples of interested parties: Customers, owners, stockholders, employees, workers on contract, contractors, suppliers, bankers, unions, partners, society, competitors, opposite pressure groups, government, regulatory bodies, neighbours etc.
(iii) Why there is a requirement to understand the needs and expectations of interested parties? Because interested parties' needs and expectations can have an effect or potential effect on the organization's ability to consistently provide products/services that meet (fulfill) customer and applicable legal requirements.
(iv) Needs and expectations = Requirements

An understanding of the needs and expectations of interested parties is an important issue as this can affect the organization's quality management system. As such, it is required that the organization remains familiar with the requirements of interested parties and maintain an awareness through monitor and review and thus make the organization to respond to the requirements appropriately. Unwillingness or reluctance to recognize the needs and expectations of interested parties will hamper a robust quality management system.

Step-by-step process:
(i) Make a team of identified persons.
(ii) The team should be asked to determine interested parties and their requirements.
(iii) The team should make a list of all such requirements with necessary details.
(iv) Assign responsibility to monitor and review such requirements to different persons or groups in the organization, so that effective decisions can be taken for the improvement.

- Keshav Ram Singhal

Organizations may contact for conducting in-house training program on (i) 'ISO 9001:2015 QMS Awareness', and (ii) 'Applying risk-based thinking.'