Limitations of Why Why Analysis

 

Limitations of Why Why Analysis

In our book 'Implementing ISO 9001:2008 Quality Management System', we mentioned 'Why why Analysis' as a tool for adding value to internal QMS. We clearly mentioned - "Do not see who is responsible. Rather consider why and what caused the problen or nonconformity. ..... Find out fundamental cause of the nonconformity and stop it happening it again. We need to ask WHY? WHY? WHY? We should not ask -- WHO? We provided examples for using Why Why method. Basically Why Why Analysis is a simple and useful technique, however we need to know its limitations.  

Many in the industry know the root cause analysis system called the 5 Whys or Why Why Analysis. It was created at Toyota and has been implemented in many other organizations that use lean manufacturing concepts. Unlike some of the more complex root cause analysis systems, 5 Whys does not require any data segmentation, regression, testing of hypotheses or other high end statistical tools. In many instances, using the 5 Whys can be done without any data collection either.

Five Whys technique is a popular technique for root cause analysis. Many people use it. Is this a suitable technique for teams? Do we have any alternate better technique for the teams? John Allspaw, SVP of Technical Operations at Etsy favors to discard Five Whys approach. He says that using the Five Whys is a good first step toward doing real root cause analysis but asking too many whys end up in blaming people.

The idea is by asking ‘why?’ at least five times, one can peel away many layers of symptoms and get to the root cause at last of a problem. At many organizations, the 5 Whys is still important for solving problems, and is the basis of the scientific approach there. In their experience, repeating ‘why?’ 5 times will usually reveal the nature of the problem.

The idea of solving a problem means that identify the root cause of problems and then come up with and implement solutions to eliminate the root cause and to prevent them from happening again.

 There are following reasons for the criticism of Why Why Analysis:

- Tendency for investigators to stop at symptoms rather than going on to lower-level root causes

- Inability to go beyond the investigator’s current knowledge – cannot find causes that they do not already know

- Lack of support to help the investigator ask the right “why” questions

- Results are not repeatable – different people using 5 Whys come up with different causes for the same problem

- Tendency to isolate a single root cause, whereas each question could elicit many different root causes

- Considered a linear method of communication for what is often a non-linear event

- Problem with the 5 Whys is that it does not always uncover the root cause when the cause is not known. Also, the 5 Whys presumes that each symptom has one cause. This is not always true, so this type of analysis does not always show several sufficient causes that are causing the symptom.

- How well the 5 Whys works depends some on the skill of the person using it. If one why has an incorrect answer, it can throw off the entire analysis. Last, this method is not always repeatable. Three people applying the 5 Whys can often come up with different answers.

- Other disadvantages include the inability of this method to tell between causal factors and the root cause, and a lack of rigor where the user is not mandated to do sufficiency testing.

 

Courtesy Sources 

- Implementing ISO 9001:2008 Quality Management System - A Reference Guide, Dr. Divya Singhal and Keshav Ram Singhal, PHI Learning Private Limited, New Delhi (Available at Amazon)

- Limitations of the Five Whys Technique in Agile Retrospectives, Savita Pahuja - Please CLICK

- Limitations of 5 Whys in CAPA and Root Cause Analysis - Please CLICK 

- Keshav Ram Singhal

 

 

BIS Permits Relaxations For Covid-19

BIS Permits Relaxations For Covid-19

To promote the supply of quality PPEs during the ongoing pandemic, Bureau of Indian Standards (BIS) has permitted relaxation in its norms of having in-house testing facilities for the following PPEs:

i) Filter Half Masks to Protect against particles of Class FFP2 as per IS 9473:2002
ii) Surgical Face Masks as per IS 16289:2014
iii) Eye Protectors as per IS 5983:1980

This has been done to enable more manufacturers to be brought in the ambit of BIS product certification scheme, which will in turn result in greater quantity of BIS certified PPEs being made available to the users. However, for such manufacturers, testing of samples for conformity to the specified requirements is being done in laboratories of BIS licensees who have in-house testing facilities, or in BIS recognized or empanelled private/government labs.

Those domestic manufacturers who are interested in applying for a BIS licence may register themselves and submit their application online through BIS website (CLICK HERE). The process of certification can be seen on BIS website (CLICK HERE). Here it is important to note that Bureau of Indian Standards (BIS) is providing access to above standards free of cost, which can be accessed free of cost through BIS website (CLICK HERE).

For any additional information, please get in touch with the nearest BIS Branch .

Best wishes,

Keshav Ram Singhal

Online training on 'ISO 9001:2015 QMS Awareness' in May 2020

Online training on 'ISO 9001:2015 QMS Awareness' in May 2020

Participants successfully completed the online training in May 2020 are:

- Umesh S. Bhagawat, Thane (Maharashtra)
- Rajdeep Arora, Ludhiana (Punjab)
- Ms. Pushpa Sasane, Pune (Maharashtra)

CONGRATULATIONS !

Keshav Ram Singhal

Accreditation and Selection of Certification Body

Accreditation and Selection of Certification Body

Accreditation

When an organization decides to implement and obtain certification to ISO 9001:2015 QMS standard or any other standard, the first work is to choose a certification body from which the organization will obtain the certification. A number of certification bodies are operating in our country, so you have a wide choice to select a certification body. It is always suggested to obtain accredited certification. A question may arise in our mind - What is accreditation? Accreditation is a link in the chain of trust. If an organization meets the requirements of ISO 9001:2015 QMS standard, the organization will receive a certificate of conformity to the standard from a certification body (also known as assessing body or conformity assessment body) after formal assessment. This certificate has most value if the certification body is professional, impartial, competent and independent. The accreditation body with the aim of checking the expertise, impartiality and independence of certification bodies carries out accreditation task. If the results are positive, an accreditation mark is issued to certification body. Accreditation is a term widely used in certification industry. It provides us confidence in the certification body that grants us management systems certification, such as ISO 9001 certification, ISO 14001 certification etc. In simple terms, accreditation is the action or process of officially recognizing someone as having a particular status or qualified to perform a particular activity. It is an acknowledgement of someone's responsibility for achievement of something.

Accreditation really means 'creating trust'. Accreditation is the act of granting credit or recognition, especially to an institution that maintains suitable standards. Accreditation is the process in which certification of competency, authority, or credibility is presented. Accreditation by an authoritative body is the formal recognition of the competence of the certification body to perform a specific task such as analysis, calibration, inspection or certification. Accreditation is the mechanism for indicating that the assessing organization for a demarcated area, the 'scope', justified confidence. Accreditation is the formal recognition that is based upon a series of international standards that focus particularly on the elements of expertise, independence, impartiality and continuity.

Nationally and internationally buyers want to be able to trust blindly the quality and safety of products / services provided by the certified organizations. If these are guaranteed, it not only benefit the buyer but also to the organization that supply the product/service. This strengthens the supplier organization's position in the market. In order to be able to provide an objective guarantee, the organization can have its quality management system assessed by an accredited certification body.

When an organization opts for the certification of ISO 9001:2015 QMS standard or any other standard, it finds in the initial stage that the certification body is accredited from an accreditation body. There are a number of accreditation bodies operating in the world that carry out the accreditation work. In India, NABCB (National Accreditation Board of Certification Bodies) grants accreditation to certification bodies. There are many accreditation bodies in the world, such as UKAS (United Kingdom Accreditation Service) in UK, RvA (The Dutch Accreditation Council - Raad voor Accreditatie) in Netherlands, ANAB (ANSI-ASQ National Accreditation Board) in USA, JAS-ANZ (Joint Accreditation System) in Australia and New Zealand etc.

RvA Public Report 2016 says, "Accrediting really means: creating trust. Nationally and internationally buyers want to be able to trust blindly the quality and safety of products and services provided. If these are guaranteed, it not only benefits the buyer but also the supplier. This strengthens his position in the market. In order to be able to give an objective guarantee, the supplier can have his products and services assessed by an accredited organization. This also applies to every area imaginable: health, environment, construction, energy, food, transport, finance etc."

The certificate issued by a certification body, which has been accredited by an accreditation body, which is an IAF MLA signatory for the scope covering the certificate, should be acceptable in the world under the principle of international equivalence. This is a very significant reason for making an appropriate choice of a certification body.

International Accreditation Forum (IAF)

The International Accreditation Forum (IAF) is the world association of Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel and other similar programmes of conformity assessment. Its primary function is to develop a single worldwide program of conformity assessment which reduces risk for business and its customers by assuring them that accredited certificates may be relied upon. Accreditation assures users of the competence and impartiality of the body accredited.

Accreditation in India

Since 1992 a need had been felt for the establishment of an accreditation body in India to establish internationally acceptable mechanism for recognition of conformity assessment results. As regards laboratories, an accreditation body under the Ministry of Science and Technology was already functioning. A committee which included various interested ministries and stakeholders including industries was established to make suitable recommendations. The work was coordinated by the then Department of Industries (Department of Industrial Policy and Promotion) and the recommendations were submitted to the Cabinet in 1996. Key recommendations included the Need for establishing an organization jointly by the Government and the industry and the need for the organization to be self-sustaining and be away from the government. Accepting the recommendations, the Cabinet Committee decided to set up Quality Council of India (QCI) as a non-profit autonomous society registered under Societies Registration Act XXI of 1860 to establish an accreditation structure in the country and to spread quality movement in India by undertaking a National Quality Campaign. Accordingly, QCI was established as the National body for Accreditation on recommendations of Expert Mission of EU after consultations in Inter-ministerial task force, Committee of Secretaries and Group of Ministers in 1996.

There is a governing council (known as Council) as the apex level body responsible for formulating the strategy, general policy, constitution and monitoring of various components of Quality Council of India (QCI) including the accreditation boards with objective to ensure transparent and credible accreditation system. Following accreditation boards are working under the structure of QCI:

- National Accreditation Board for Certification Bodies - NABCB
- National Accreditation Board for Education and Training - NABET
- National Accreditation Board for Hospitals and Healthcare Providers - NABH
- National Accreditation Board for Testing and Calibration Laboratories - NABL - However, it should be noted that NABL continues to be a separate legal entity.

The National Accreditation Board for Certification Bodies (NABCB) provides accreditation to Certification and Inspection Bodies based on assessment of their competence as per the Board's criteria and in accordance with International Standards and Guidelines. The National Accreditation Board for Certification Bodies (NABCB) is internationally recognized and represents the interests of the Indian industry at international forums through membership and active participation with the objective of becoming a signatory to international Multilateral / Mutual Recognition Arrangements (MLA / MRA).

NABCB is a member of International Accreditation Forum (IAF) and Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. Global G.A.P., Food Safety Management Systems and Information Security Management Systems NABCB is also a full member of International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection. National Accreditation Board for Certification Bodies (NABCB), linked to Quality Council of India (QCI), grants accreditation to certification bodies. In addition to this, many foreign accreditation bodies have also granted accreditation to certification bodies operating in India.

Some of the foreign accreditation bodies are:

- UKAS - United Kingdom Accreditation Service
- RvA - Raad voor Accredatie (The Dutch Council of Accreditation)
- ANAB - ANSI-ASQ National Accreditation Board
- JAS-ANZ - Joint Accreditation System of Australia and New Zealand
- SCC - Standards Council of Canada
- JAB - Japan Accreditation Board
- IAR - IAR Accreditation Service

There are accreditation bodies in neighbouring countries too, some of which are:
- CNAS - China National Accreditation Service for Conformity Assessment
- PNAC - Pakistan National Accreditation Council
- SLAB - Sri Lanka Accreditation Board for Conformity Assessment
- MQA - Maldives Qualifications Authority
- BAB - Bangladesh Accreditation Board
- NAFP - National Accreditation Focal Point - The Bhutan Standards Bureau has established a National Accreditation Focal Point (NAFP) through the SAARC-PTB cooperation framework to facilitate accreditation of conformity assessment bodies in the country and provide access to international recognized accreditation services.

Nepal has yet to establish its own National Accreditation Board to oversee certification and inspection bodies as well as accreditation of testing and calibration laboratories to demonstrate their competence

Many of the accreditation bodies are the members of International Accreditation Forum (IAF) and these accreditation bodies agree to the IAF Multilateral Recognition Agreement (MLA) recognizing the equivalence of other members' accreditation to their own.

There are more than fifty certification bodies operating in India, which have been granted accreditation either from NABCB or from any other foreign accreditation body. In such a situation, first you should collect information about the certification bodies operating in your country and then you should contact the certification bodies with brief description about your organization, nature of your business and your assessment requirements. You should also find out whether the certification body is accredited to provide certification in your area of business. In this connection, it is important to check that its accreditation scope includes the technical sector of your organization. The certification bodies are accredited scope wise.

There are 39 scope sectors as mentioned by IAF, a few of them are as under:
- Agriculture, forestry and fishing,
- Mining and quarrying,
- Food products, beverages and tobacco,
- Nuclear fuel,
- Chemicals, chemical products and fibres,
- Pharmaceuticals,
- Transportation, storage and communication,
- Information technology,
- Engineering services,
- Education, etc.

Selection of a certification body

Since there are too many certification bodies operating in our country, you need to select a accredited certification body, for which you should know the details of accreditation, certification services and cost of certification. Therefore it is better to write letters or send emails to several certification bodies asking their accreditation, certification services and cost of certification. Upon receipt of your letter / email, the certification body will advise you the certification process and a quotation for the costs including the certification fee. Accordingly, you will have quotations from several certification bodies and you will be in a position to decide a certification body by which you will obtain ISO 9001:2015 QMS certification. Quotation will normally include a one-time certification fee (covering a period of three years), costs per day of auditing work (before, during and after certification), travel and other expenses. The number of workdays required for each audit will depend on the size of operation and the location of the organization to be audited. Please note that while deciding a certification body, don't just go for a cheap or non-accredited certification. You need to make a wise choice to get maximum benefits out of certification. Always select an accredited certification body.

Best wishes,

Keshav Ram Singhal

Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS

Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS

I am glad to inform that Pothi.com has released my book 'Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS'. This book is a concise guide for applying Risk-based Thinking in an organization implementing ISO 9001:2015 QMS. It is helpful to executives and professionals having responsibility to implement QMS in the organization.

Please CLICK HERE for Pothi.com link.

Contents

Contents of the book are as under:

- Preface
# 01 - Risk-based Thinking - Introduction
# 02 - Historical background
# 03 - Defining 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
# 32 - Evaluation Questionnaire
# 33 - Your feedback
# 34 - Acknowledgement
# 35 - Other Book by the Author

If you wish to get the concise guide, please CLICK HERE for Pothi.com link.

I hope readers will find this concise guide useful. If you have any questions on risk-based thinking, this book will provide you an answer. If you have any other questions, please communicate the same to me. I'll make an effort to reply such questions through my blog and Facebook group.

Suggestions and comments are invited to improve my effort.

With best wishes,

Keshav Ram Singhal

A Concise Guide on Creating and Updating Documented Information

A Concise Guide on Creating and Updating Documented Information

I am glad to inform that Pothi.com has released my book 'A Concise Guide on Creating and Updating Documented Information'. This book is a concise guide for creating and updating documented information in organizations implementing ISO 9001:2015 quality management system (QMS). It is helpful to executives and professionals having responsibility to implement QMS in the organization.

Please CLICK HERE for Pothi.com link.

Contents

Contents of this book are as under:

- Preface
- List of questions on documented information
- Documented information in ISO 9001:2015 QMS
- Structure of documented information
- Purpose and benefits of documented information
- Is quality manual required?
- Developing documented information
- Quality manual (or QMS manual, description book or instructions manual)
- Procedures
- Work instructions
- Forms
- Quality plan
- Approval of documented information
- Bibliography

Listed Questions

I have listed 48 questions on documented information. You can get the answers to these questions in this concise guide. These 48 questions are:

1. Does ISO 9001:2015 QMS standard specify any particular format or design for documented information to maintain and to retain?

2. Earlier version ISO 9001:2008 QMS standard used the terms 'document', 'record', '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 has been used in ISO 9001:2015 QMS standard requirements. What is the new term?

3. Can an organization (implementing ISO 9001:2015 QMS) use the terms 'document', 'record', 'documented procedure', 'quality manual' and 'quality plan'?

4. Can documented information be in any media?

5. ISO 9001:2015 QMS standard has used two types of terms: 'maintain documented information' and 'retain documented information'. What do these terms mean?

6. What are the provisions of ISO 9001:2015 QMS standard with regard to the organization's quality management system documentation? Also state the clause reference of the standard.

7. Does an organization (implementing ISO 9001:2015 QMS standard) mandatory need to develop a quality policy?

8. . Does an organization (implementing ISO 9001:2015 QMS standard) mandatory need to develop a quality manual?

9. . Does an organization (implementing ISO 9001:2015 QMS standard) mandatory need to establish quality objectives?

10. Where should an organization (implementing ISO 9001:2015 QMS standard) establish quality objectives?

11. Why an organization (implementing ISO 9001:2015 QMS standard) need to create, update and retain documented information?

12. Why an organization (implementing ISO 9001:2015 QMS standard) need to maintain documented information?

13.What documented information needs to maintain by an organization implementing ISO 9001:2015 QMS standard?

14. What documented information needs to retain by an organization implementing ISO 9001:2015 QMS standard?

15. What is the basis for establishing, implementing and maintaining a quality management system in an organization?

16. Does ISO 9001:2015 QMS standard specify any particular format or design for documented information to maintain and to retain?

17. - What levels documented information most organizations prefer to opt for implementing ISO 9001:2015 QMS?

18 - Is it necessary for an organization to have three levels of documented information separately?

19 - Can an organization combine Level 'A' and Level 'B' documented information in one manual or can have separate manual for different documented information?

20. Why QMS documented information of one organization differ from the other organization? Give reasons.

21. What are several purposes and benefits of having documented information in the quality management system?

22 - Is quality manual required in ISO 9001:2015 QMS?

23 - Why responsibility for development of documented information be defined?

24 - What is the role of a task force in the development of documented information?

25 - Is initial training necessary on developing documented information?

26 - Is developing documented information the most important activity in ISO 9001:2015 QMS implementation process?

27.Who should be assign the duties of writing documented information to be maintained by the organization?

28. There is an increasing trend of using electronic media for creating and updating documented information? What are the reasons?

29. What is the primary purpose of maintaining Quality manual, QMS manual, description book or instructions manual?

30. What should be contained in Quality manual, QMS manual, description book or instructions manual?

31. What is coordinated by the coordinator of the task force?

32. What steps may be useful for the preparation of the Quality manual, QMS manual, description book or instructions manual?

33. What are the approaches to write the Quality manual, QMS manual, description book or instructions manual?

34. What is a procedure?

35. What a documented procedure usually covers?

36.Does ISO 9001:2015 QMS standard specify specific mandatory documented procedures?

37. Why should an organization determine procedures to be necessary?

38. What procedures may be determined?

39. What is work instructions?

40. Why work instruction should be developed?

41. What should be included in work instructions?

42. What steps for developing work instructions may be useful?

43. Why are forms created?

44. What should be included in forms?

45. What is quality plan?

46. What should quality plan contain?

47. Why should approval of the documented information be taken?

48. Who should approve the documented information?

If you wish to get the concise guide, please CLICK HERE for Pothi.com link.

I hope readers will find this concise guide useful. If you have any questions on documented information, please communicate the same to me. I'll make an effort to reply such questions through my blog and Facebook group.

Suggestions and comments are invited to improve my effort.

With best wishes,

Keshav Ram Singhal

Online training on 'ISO 9001:2015 QMS Awareness' in April 2020

Online training on 'ISO 9001:2015 QMS Awareness' in April 2020

Participants successfully completed the online training during April 2020 are:

- Sudipta Hore, Kolkata
- Anand S. Patel, Ahmedabad
- Thrinath Gogineni, Havambhavi (Bellary City), Karnataka State
- C K Kodanda Pani, Bangalore
- Ms. Ashwani Singh (AsHi Negi), Pune
- Justine Jacob C. Erfe (Justine Erfe)* of Phillipines

CONGRATULATIONS !

Keshav Ram Singhal

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

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

Dear friend,

Greetings.

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

I have decided to conduct Third Batch of Free Online Training on "ISO 9001:2015 QMS Awareness" starting from 3rd May 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. Trainer-trainee interaction will be through WhatsApp. Name of participants successfully attending the training will be posted in this blog as well as in the facebook group 'Quality Concepts, Tools, Techniques and ISO 9001 QMS Awareness'. Every participant is required to complete and send completed assignments to the trainer as early as possible so as to complete all assignments before the end of lock down period..

Target participants

Working management executive, academician, auditor and person 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 on or before 3rd May 2020 by mentioning the subject line of the email as 'Enrollment for Third Batch - Online Training' with following details:
- Name,
- Occupation / Designation,
- Organization,
- Postal 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.

Participant should also attach proof of identity.

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 in all assignments. Successful participant will get an appreciation communication from the trainer.

Successful participants will get appreciation communication by email from the trainer and their names will be announced in the Facebook group as well as in Trainer's blog on 'Quality Concepts and ISO 9001:2015 QMS Awareness'. Presently the trainer has limited facilities. No individual certificate. Please note that this is a free online training. The training will add value to your knowledge. Best wishes.

Your investment - Time for reading the training material and completing the assignments. Earlier batch participants took 8 to 10 hours period in reading and completing the assignments. No fee is being charged for this training.

Participants of Earlier Batch - Participants of earlier batch can also continue their learning, who have missed receipt of training material due to non-submission of assignments. They should send the completed assignments as early as possible.

Participants already completed training - Following participants successfully completed the online training during April 2020 are:
- Sudipta Hore
- Anand S. Patel
- Thrinath Gogineni
- C K Kodanda Pani
- Ms. Ashwani Singh (AsHi Negi)
- Justine Jacob C. Erfe (Justine Erfe)* of Phillipines

CLICK HERE to join Facebook group 'Quality Concepts, Tools, Techniques and ISO 9001 QMS Awareness'.

Please share this information among others for their benefit.

Happy Learning. Best wishes,

Keshav Ram Singhal
Trainer

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.'

Applying Risk-based Thinking - External and internal issues of an organization

Applying Risk-based Thinking - External and internal issues of an organization

ISO 9001:2015 QMS standard requires determining external and internal issues that are relevant to the organization's purpose and the organization's strategic direction and that affect the organization's ability to achieve the intended results of the QMS. In this connection, note given at the end of the requirements of clause 4.1 is relevant. We should understand three basic points - (i) Issues may be positive and/or negative factors/conditions. (ii) External issues may arise from external environment that can be from legal, technological, competitive, market, cultural, social and economic environments. (iii) Internal issues are issues that an organization's people face in the organization due to internal environment. These are the issues related to values, culture, knowledge and performance of the organization.

Some external issues may relate to:

- Government regulations that affect the organization's performance,
- Changes in law that has an impact on the organization,
- Economic shifts in the organization's markets,
- Competition the organization is facing,
- Events (such as business fairs, customers meet etc) that may improve or affect corporate image of the organization,
- Changes in technology (yet not adopted by the organization),
- What others (external interested parties) require from the organization, such as bankers requires timely submission of statement related to hypothecated goods, customer requires timely delivery of the product/service etc.

Some internal issues may relate to:

- Accountability of the people working in the department/ organization - whether defined or not, whether defined adequately or not,
- Coordination with different groups/people/departments in the organization,
- Performance,
- Monitoring of activities,
- Allocation of individual tasks/responsibilities/job specifications,
- Formal reporting relationships,
- Grouping of people/department/processes,
- Communication,
- Delegation of authorities,
- Availability of the procedure for the activity performance, measurement, monitoring, evaluating,
- Product/service offerings,
- Organizational structure (needs changes),
- Policies,
- Assets (such as facilities, property, equipment, technology etc.),
- Capabilities of people,
- Information system within the organization,
- Relationship of people within the organization,
- Organization's culture,
- Standards/industry guidelines/business model adopted by the organization and its awareness among people within the organization,
- Habits of people, such as late coming, leaving early, taking frequent leave from work etc.

Internal context may be anything within the organization that may influence the way in which the organization manages its internal issues..

- 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 organization and its context

Applying Risk-based Thinking: Understanding the organization and its context

Clause 4.1 of ISO 9001:2015 QMS standard deals with the requirements related to the understanding the organization and its context. According to the requirements of the standard, an organization needs to carry out the following:

(i) Determine: Internal and external issues (positive and negative factors or conditions) relevant to organization's purpose, strategic direction and that can affect organizational ability to achieve intended results
(ii) Monitor and review: Information about the determined external and internal issues (positive and negative factors/conditions)

Clarification:
(i) There are many issues that can make easier the understanding the external context of the organization. Such issues may arise from legal, technological, competitive, cultural, social and economic environments and that can be global, national, regional or local.
(ii) There are many issues that can make easier the understanding the internal context of the organization. Such issues may relate to the organization's value, culture, knowledge and performance.

We see that the requirements of ISO 9001:2015 QMS standard starts with asking for determination of all issues that can enhance or interrupt achievement of the quality management system outcomes. The organizational issues may be internal and/or external that may be well defined, substantially subjective or not so well defined. We need to understand them. A subjective issue may be internal issue within and among groups/people in an organization. It is required for the organization to monitor and review all those issues that can affect achievement of defined goals. With monitoring and reviewing internal and external issues, an organization is better prepared to make improvements and thus leads to a success path. The management of the organization should identify persons, who are well-versed with the organization and its processes and who understand the standard's requirements very well. These persons should be encouraged to create a suitable, adequate and effective quality management system by monitoring and reviewing internal and external issues. The persons in the organization should make their best efforts to understand related issues and process details, so that they may contribute to achievement of the defined goals.

Step-by-step process:
(i) Make a team of identified persons in the organization.
(ii) The team should be asked to think and identify all positive and negative factors and conditions that are relevant and that can affect achievement of organizational goals.
(iii) The team should make a list of all such issues with necessary details.
(iv) Assign responsibility to monitor and review such issues to different persons or groups in the organization, so that effective decisions can be taken for improvement.

ISO 9001:2015 QMS standard in its clause 4.1 makes an emphasis on clear understanding of the organization's context. The standard requires organization to:
(i) determine external and internal issues (positive and negative factors or conditions) that are relevant to its purpose and its strategic direction and that affect organization's ability to achieve the intended result(s),
(ii) monitor and review information about the determined external and internal issues (positive and negative factors or conditions).

The intent of above requirements is to understand important issues that can affect, either positively or negatively, the way the organization manages its quality management system to achieve the desired result(s). Requirements mentioned in clause 4.1 is too general and one may think as many issues that may not be relevant. Consider only those issues that are relevant to the quality management system.

Why an organization need to determine external and internal issues? one may answer, it is a requirement. But why is this a requirement? Because (i) the organization needs to take better decisions based on evidence, (ii) the potential benefits of implementing ISO 9001:2015 QMS standard to an organization is addressing risks and opportunities associated with its context and objectives. This leads to improvement in the quality management system.

Addressing risks and opportunities lead to proactively managing uncertainties that lead to better decisions based on evidence. This reminds 'evidence-based decision making' principle among the seven quality management principle on which ISO 9001:2015 QMS standard is based. Clause 0.1 also has a reference of the potential benefits of implementing ISO 9001:2015 QMS.

Internal context of an organization is the environment, in which organization targets to achieve its objectives. Issues that need to be considered are related to culture, beliefs, values, or principles inside the organization, as well as the complexity of processes and organizational structure. Typical examples of internal context related issues may be - Products/services offerings, Governance, Organizational structure, Roles, Responsibilities and authorities, Organizational assets (facilities, building, machinery, equipment, technology), Information system and decision making process, Relationship of staff, Perception of internal stakeholders (owners, suppliers, partners), Organization culture, Guidelines etc.

External context of an organization relates to the issues that may arise from legal, cultural, social, technological, competitive, economic environment that can be global, national, regional or local. Typical examples of external context related issues may be - Government regulations, changes in law, market competition, events (such as trade fairs), etc. These factors should be considered, while managing risks, uncertainty and opportunities and also at the time when you make decisions that may affect quality of the product/service your organization provides.

ISO 9001:2015 QMS standard does not speak on the method to determine such issues. It is for the organization to apply its own suitable method. One such method to determine the internal and external issues may consists following steps - (i) The top management of the organization should constitute a team of identified persons, who are well-versed with organization and its processes, (ii) The team members should think individually as well as collectively and identify positive/negative factors and conditions that are relevant and that can affect achievement of organization's goals/objectives, (iii) All such identified issues should summed-up, (iv) the team should also monitor and review identified issues from time to time.

While auditing the standard's requirements, auditor should look into the objective evidence how the organization determined the issues related to the context of the organization.

- 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.'