Preservation of Product

It is the intention and purpose of ISO 9001:2008 QMS Standard that the organization needs to ensure to appropriately handle the product to prevent damages and mix-ups. It is the intention of the Standard that the product, during all stages of product realization from acquiring from the suppliers to the delivery to the intended destination, must be protected. Clause 7.5.5 of ISO 9001:2008 QMS Standard mentions the relevant requirements for preservation of product. According to the requirements of the Standard, during internal processing and delivery to the intended destination (= during product realization processes and also during delivery process), the organization must preserve conformity of product. This preservation must include identification, handling, packaging, storage and protection; and must apply to the constituent parts of the product.



It will be good if following precautions are taken:
(i) Mark designated area for storing product (that conform to requirements)
(ii) Mark designated area for storing nonconforming product (to avoid its mix-up with conforming product)
(iii) Store the conforming product and nonconforming product in their designated area
(iv) Control inward receipt at every stage of the product realization process
(v) Control outward release
(vi) Make proper attention to identification by marking appropriately
(vii) Make proper attention to packaging
(viii) Periodically review storage, packaging and delivery methods to intended destination

With best wishes,

Keshav Ram Singhal

Understanding the meaning – Continual improvement …. Constant improvement …. Continuous improvement

I was addressing a group of participants in a training programme on ‘ISO 9001 QMS Awareness’, while discussing and telling requirements relating to continual improvement, one participant asked me about ‘continual improvement’ phrase used in ISO 9001:2008 QMS Standard and relevant meaning of ‘continual improvement’, ‘continuous improvement’ and ‘constant improvement’ for QMS implementation.



“Continual, constant, continuous all refer to a succession of occurrences. The two adjectives ‘continual’ and ‘continuous’ are synonyms, but not equivalent. The word "continual" incorporates "continuous" and not the other way around. People use ‘continuous’ and ‘continual’ as if they are exact synonyms, but there is difference between them as we have seen from the above and we can understand distinguish between these two. In the eyes of many QMS Consultants there is no difference between ‘continual’ and ‘continuous’. The concept of ‘continual’ improvement has always been used by Deming in reference to the general processes of improvement. Continual improvement is broader in scope than continuous improvement. We can say that ‘continuous improvement’ is a subset of ‘continual improvement’. The word ‘continual’ incorporates ‘continuous’ and not the other way round.” – This opinion is based on the following:


Continual

(adjective)Con-tin-u-al
(1) Happening without interruption or cessation
(2) Continuous in time
(3) Of regular or frequent recurrence
(4) Often repeated
(5) Very frequent
(6) Duration that continues over a long period of time, but with intervals of interruption



Synonyms of Continual
(1) Unceasing
(2) Ceaseless
(3) Incessant
(4) Uninterrupted
(5) Successive
(6) Recurrent
(7) Repetitive
(8) Repetitious

Noun
(1) Continuality
(2) Continualness


Examples:
(1) Continual misunderstanding between nations
(2) Continual improvement is a requirement of ISO 9001:2008 QMS Standard.
(3) The organization must continually improve the effectiveness of the quality management system.
(4) Continual improvement of the system
(5) The continual street repair disrupted traffic for nearly two years.

Constant

Constant implies always recurring in the same way, under uniform conditions, with similar results, and the like.

Examples:
(1) Constant repetition of the same mistakes
(2) Constant pressure


Continuous



(adjective)Con-tin-u-ous
(1) Being in immediate connection
(2) Being in immediate relation
(3) Uninterrupted in time
(4) Without cessation
(5) Duration without interruption

Adjective
(1) Continuously

Noun
(1) Continuousness

Continuous emphasizes the idea that the succession is unbroken, but successive recurrences are not very close together as observed in continual.

Examples:
(1) The continuous life of the universe
(2) A continuous pattern of dots
(3) Continuous coughing during the concert
(4) The continuous humming of the fluorescent lights provided him a headache.

ASQ Basic Concept

ASQ basic concept states, “Continuous improvement is an ongoing effort to improve products, services or processes. These efforts can seek “incremental” improvement over time or “breakthrough” improvement all at once. ….. The terms continuous improvement and continual improvement are frequently used interchangeably. But some quality practitioners make the following distinction: Continual improvement: a broader term preferred by W. Edwards Deming to refer to general processes of improvement and encompassing “discontinuous” improvements—that is, many different approaches, covering different areas. Continuous improvement: a subset of continual improvement, with a more specific focus on linear, incremental improvement within an existing process. ….”

CONCLUSION

Accordingly, following conclusions are relevant for implementing any management systems (such as ISO 9001, ISO 14001 etc.):

(1) “Continual, constant, continuous all refer to a succession of occurrences.
(2) The two adjectives ‘continual’ and ‘continuous’ are synonyms, but not equivalent.
(3) Whether the word ‘continual’ incorporates ‘continuous’ or ‘continuous’ incorporates ‘continual’, it is irrelevant for a management system professional to find the answer.
(4) People use ‘continuous’ and ‘continual’ as if they are exact synonyms.
(5) In the eyes of many Management Systems Consultants there is no difference between ‘continual’ and ‘continuous’.
(6) The concept of ‘continual’ improvement has always been used by Deming in reference to the general processes of improvement.
(7) For all practical purposes for implementing any management systems in any organization, the phrases ‘continual improvement’, ‘continuous improvement’ and ‘constant improvement’ are, to all intents and practical purposes, the same thing.
(8) It may be 'nice' to understand the etymology of these phrases but it has little practical application when implementation is more important.
(9) We often do ourselves no good in the Quality Profession, in managements' eyes, when we (endlessly) debate the correct phrase usage, instead of delivering results.
(10) The important thing is to continually apply an improvement culture. Promote it, support it and move on.

- K. R. Singhal

‘Oxebridge’ Calls for Temporary Halt to ISO 9001:2015 Development

‘Oxebridge’ Calls for Temporary Halt to ISO 9001:2015 Development

Christopher Peris

‘Oxebridge Quality Resource International’ (‘Oxebridge’) is a quality management implementation boutique started by Christopher Peris, a process engineer, in 1998. I am impressed with his passion to quality management implementation as he believes that:

- ISO 9001 QMS implementation should not shut down the operations of the organization that implements the QMS,
- ISO 9001 implementation should not require endless meetings, over-calibration or unnecessary documentation
- ISO 9001 consultants should do the implementation work themselves, not require the client to do it.

His approach to implement QMS is different from others that has a right direction philosophy: 'Implementation should be fast, low-impact and highly effective.'

International Organization for Standardization (ISO) is in the process of developing ISO 9001:2015.and 'ISO/TC 176 Sub-committee 2' has already issued working draft for ISO 9001:2015. Many QMS professionals feel that development work lacks many points; however, Christopher Peris has taken the lead to mention those ‘converging factors’ that will damage the QMS standard. In this connection ‘Oxebridge’ has released a paper ‘A Public Call for Temporary Cessation of Work on the Development of ISO 9001:2015’ on April 15, 2013 citing four ‘converging factors’ that it feels will damage both ISO and the ISO 9001 QMS Standard, if the standard is allowed to proceed. One of the factors is: ‘Failure to fully develop the foundational Quality Management Principles prior to drafting of the Working Draft.’ 'ISO/TC 176 Sub-committee 2' has already issued working draft for ISO 9001:2015 and the foundational quality management principles are yet to be developed.

Those interested to know more in this regard may read the article on the subject at http://www.oxebridge.com/emma/?p=1589 .

With best wishes,

Keshav Ram Singhal

Fundamentals of Quality Management System

ISO 9001:2008 QMS standard is a generic standard that provides requirements for quality management system. It also refers to ISO 9000:2005 as normative reference. ISO 9000:2005 is a standard that belongs to ISO 9000 family and its title is 'Quality management system - Fundamentals and vocabulary'.

ISO 9000:2005 standard describes fundamentals of quality management system and also specifies the terminology used and eight quality management principles. There are twelve fundamentals of quality management system that has been mentioned in ISO 9000:2005 standard. These are:

1. Rational for quality management system
2. Requirements for quality management systems and requirements for products
3. Quality management systems approach
4. The process approach
5. Quality policy and quality objectives
6. Role of the top management within the quality management system
7. Documentation (value of documentation and types of documents used in quality management systems)
8. Evaluating quality management systems (evaluating processes within the quality management system, auditing the quality management system, reviewing the quality management system and self assessment)
9. Continual improvement
10. Role of statistical techniques
11. Quality management systems and other management system focuses
12. Relationship between quality management systems and excellence models

Think about the above twelve fundamentals and make use of them for strengthening your organization's quality management system.

With best wishes,

Keshav Ram Singhal

Your Email Motivates Me

Email dated 26 February 2013 from Dr. R. H. G. Rau, Past President, National Centre for Quality Management

"Congratulations. It sure is a milestone achievement. Warm personal regards, Rau"


Email dated 27 March 2013 from Mr. Asgar Uddin Sirdar (IRCA Registered Lead Auditor)
Qualification: BE Metallurgy, Company: Larsen & Toubro Ltd., Designation: QAQC manager

"I am a supporter of your blog. It is good."

Email dated 3 April 2013 from Mr. Vinesh Lachman, Quality Assurance Consultant, Durban, South Africa

"I am extremely delighted to have read your blog, and to see my passion reflected is beyond words. ..."

Email dated 16 April 2013 from Prof. H. C. Patel, Mumbai

"Liked write-up. Good illustration."

Types of audit

I received an email from a QAQC Manager interalia stating, “I want to know what is surveillance audit, periodic audit and any other audit type you know.” Although I replied the email giving some clarification, however I think it would be better if I write a write-up on the subject matter.

First, we should understand what an audit is. International Standard ISO 9000:2005 defines an audit as “systematic, independent and documented process (set of interrelated or interacting activities which transform inputs into outputs) for obtaining audit evidence (records, statements of fact or other information which are relevant to the audit criteria and verifiable) and evaluating it objectively to determine the extent to which audit criteria (set of policies, procedures or requirements relating to audit) are fulfilled.”

Accordingly, an audit is a systematic, independent and systematic process. The purpose of an audit is to obtain audit evidence and evaluating it objectively against the audit criteria.



Audit types

An audit can be categorized as one of the three audit types, which are as under:
- First party audit
- Second party audit
- Third party audit

First party audit is conducted by the organization itself (or conducted on behalf of the organization) for internal verification, review and other purpose. First party audit is also known as ‘internal audit’ and it is an internal management tool, by which an organization check the health of its management system. Organizations implementing management systems (such as ISO 9001:2008 QMS, ISO 14001:2004 EMS) are required to conduct internal audit at planned intervals.

Second party audit is conducted on a supplier or an organization (excepting a customer) by or on behalf of a party (such as a customer) having an interest in the organization. Second party audit is also known as supplier audit and it is a vendor assessment tool.

Third party audit is conducted for certification purpose and this type of audit is also known as certification audit. This type of audit is conducted by an external, independent audit organization (generally known as certification body or certification body). An organization that seeks certification to a management system is required to undergo certification audit. Certification body carries out three kinds of audit for certification purpose – (i) Adequacy audit – An audit of documentation, (ii) Onsite certification audit – Onsite verification of the management system, and (iii) Surveillance audit – Surveillance audit is a periodic audit (conducted from time to time) to ensure that organization still meets the requirements of the management system standard. Periodic audit is an audit for an intermediate period (e.g., one year) or an audit carried out at specified intervals – usually every one year.



Audit in ISO 9001:2008 QMS

ISO 9001:2008 QMS Standard, Clause 8.2.2, requires organization to conduct internal audit at planned intervals. Accordingly, conducting internal audit at planned intervals is must for an organization implementing ISO 9001:2008 QMS Standard. The Standard does not mention any requirement with regard to second party (supplier) audit or third party (certification) audit. Certification is not a requirement of the Standard. An organization may implement ISO 9001:2008 QMS Standard without obtaining its certification.

With best wishes,

Keshav Ram Singhal

Your Email Motivates Me

Email dated 26 February 2013 from Dr. R. H. G. Rau, Past President, National Centre for Quality Management

"Congratulations. It sure is a milestone achievement. Warm personal regards, Rau"


Email dated 27 March 2013 from Mr. Asgar Uddin Sirdar (IRCA Registered Lead Auditor)
Qualification: BE Metallurgy, Company: Larsen & Toubro Ltd., Designation: QAQC manager

"I am a supporter of your blog. It is good."

Email dated 3 April 2013 from Mr. Vinesh Lachman, Quality Assurance Consultant, Durban, South Africa

"I am extremely delighted to have read your blog, and to see my passion reflected is beyond words. ..."

Appointing a Consultant for developing and implementing ISO 9001 QMS in your organization and his role

Many executives feel necessity of consultant for developing and implementing ISO 9001:2008 Quality Management System in the organization. A question arises: Whether appointing or engaging a consultant necessary? No, appointing or engaging a consultant is not necessary for implementing any management systems' standard including ISO 9001:2008 QMS Standard, if organization's people are aware of the standard's requirements and they have confidence for implementation. Many organizations in the world have implemented ISO 9001:2008 QMS Standard without engaging or appointing any consultants. As regard appointing/engaging a consultant, the organization should make an assessment and determine whether a consultant is required.



Why organizations appoint or engage consultant? Appointing or engaging a consultant may be worthwhile investment. A good consultant always effect speedy transfer of knowledge and skills to the organization. A consultant is needed to provide guidance to keep the implementation programme on track. A good consultant provides the people power to complete the work when needed, with no further costs or commitment. There are five general reasons to appoint or engage consultants:
- First, the consultants have experience, expertise and time that employees of an organization may not. An organization generally turns to consultant to fill the knowledge and time gaps.
- Second, consultant generally provide flexibility of time. A consultant may work any time - including nights, weekends and holidays and leave when the project is completed.
- Third, Consultant offers the latest knowledge and objective point of view. A good consultant always brings the latest and unbiased ideas from his wide experience.
- Fourth, a consultant is more efficient and focus on assigned project with sincerity.
- Fifth, engaging a consultant may be proof of honest endeavour. An organization may use consultant to show that an effort is being made to correct and fill gaps in compliance with requirements and regulations.

Thus, a consultant may be an important and relevant resource to assist and guide an organization in developing, implementing and maintaining ISO 9001:2008 QMS.



However, it is essential before engaging/appointing a consultant, to check his working experience and knowledge on standards. Costs are important consideration in deciding to engage/appoint a consultant, therefore, the organization should obtain information about the consultant's cost from several consultants. However, it should be clear while deciding engaging/appointing a consultant that the cheapest consultant may always not be the best. Organization should make an emphasis on the consultant's qualification, knowledge and experience.

Role of the consultant: It is necessary to establish the role of the consultant in the organization. Decide: (i) What the consultant is expected to do? and (ii) What the organization people are expected to do or provide? Hiring/engaging/appointing a consultant should not be regarded as an exercise in shifting the responsibility for establishing the quality management system to someone else.

With best wishes,

Keshav Ram Singhal



How can I get more articles?
This article is included in ‘Awareness Series on QMS’ containing more than 50 articles edited by KESHAV RAM SINGHAL. You can get this series by sending your subscription that is very nominal. You should send an email to keshavsinghalajmer@gmail.com asking subscription details of the Awareness Series on QMS.

I need Training or Consultancy help. Can you help?
Yes, we can certainly help you. We are expertise in implementation steps and can help you fast track your way to an effective and profitable QMS. We can provide you online training and/or consultancy help. If you need help in developing or implementing your ISO 9001:2008 QMS, please email us at keshavsinghalajmer@gmail.com giving details of your requirements.

Feedback is valuable
If you feel this article is informative or if you would like to provide us your feedback, do send us an email with your comments or write your comments in the space provided below the article. If you feel this blog could help your supplier, customer or other business associate, feel free to refer this blog to them.

Revision of ISO 9001:2008 QMS Standard – Working Draft ISO 9001:2015 refers to ‘Context of the Organization’ in Clause 4

Clause 4 of ISO 9001:2008 QMS Standard mentions requirements of ‘quality management system’ that has following sub-clauses:

4 Quality management system
4.1 General requirements

4.2 Documented requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records

Now the working draft for forthcoming ISO 9001 mentions clause 4 as ‘Context of the organization’ instead of ‘Quality management system’ as in ISO 9001:2008 QMS Standard. Clause 4 of the working draft issued by ISO/TC 176 Sub-committee 2 mentions requirements of ‘context of the organization’ that has following sub-clauses:

4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system

Understanding the organization and its context

This is a new addition that requires:
- Organization to determine internal and external issues relevant to the organization’s purpose and that can affect organization’s ability to achieve desired results
- Organization to consider such issues for determining risks and opportunities

Understanding the needs and expectations of interested parties

This time understanding the needs and expectation of interested parties is included that requires:
- Organization to determine interested parties relevant to organization’s quality management system
- Organization to determine QMS related requirements of such interested parties

Determining the scope of the quality management system

Clause 1.1 of ISO 9001:2008 QMS Standard discusses the scope in general but now to determine the scope for the QMS will be a requirement to establish organization’s QMS scope. Organization needs to determine boundaries and applicability of its QMS by considering internal and external issues, needs and expectations of interested parties. It is now a requirement to mention the scope and also any exclusion in the documented information.

Quality management system

Requirements mentioned in the working draft is more or less similar to clause 4.1 of ISO 9001:2008 QMS Standard, however following additional requirements have been added in the working draft:

- Organization to determine risks to quality performance where unintended output is produced and/or process interaction is not effective.
- Organization to allocate responsibilities and authorities for particular processes or set of processes.
- Organization to ensure that (new or revised) processes continue to deliver desired results.

We will post more articles on ISO 9001 QMS Standard revision.

Please also read my earlier articles ‘Revision of ISO 9001:2008 QMS Standard’ and ‘Revision of ISO 9001:2008 QMS Standard – Working Draft has 10 clauses’ posted in this blog. I will be happy to have your comments and reaction to the write-up.

With best wishes,

Keshav Ram Singhal




I need Training or Consultancy help. Can you help?
Yes, we can certainly help you. We are expertise in implementation steps and can help you fast track your way to an effective and profitable QMS. We can provide you online training and/or consultancy help. If you need help in developing or implementing your ISO 9001:2008 QMS, please email us at keshavsinghalajmer@gmail.com giving details of your requirements.

Feedback is valuable
If you feel this article is informative or if you would like to provide us your feedback, do send us an email with your comments or write your comments in the space provided below the article. If you feel this blog could help your supplier, customer or other business associate, feel free to refer this blog to them.

Revision of ISO 9001:2008 QMS Standard – Working Draft has 10 clauses

'ISO/TC 176 Sub-committee 2' has issued working draft for ISO 9001 and it contains ten clauses instead of eight as in ISO 9001:2008 QMS Standard.


In short, clauses in the working draft are as under:
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement


ISO 9001:2008 QMS Standard contains eight clauses as under:
1. Scope
2. Normative reference
3. Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement


Looking to the working draft, we come to a conclusion that there will be too many changes in the forthcoming ISO 9001 QMS Standard. ISO 9000 series had undergone major revision with the arrival of ISO 9000:2000 series in the year 2000 and ISO 9001:2000 certifiable standard contained requirements of quality management system to be implemented by organizations. Thereafter in the year 2008, a revised standard ISO 9001:2008 was issued, but with minor and editorial changes. But this time we will see major revision.

ISO 9001:2015 Working Draft also suggests PDCA (Plan-Do-Check-Act) methodology. Requirements in clause 4, 5 and 6 related to 'Plan', requirements in clause 7 and 8 relate to 'Do', requirements in clause 9 relate to 'Check' and requirements in clause 10 related to 'Act' of the PDCA methodology.


We will post more articles on ISO 9001 QMS Standard revision.


Please also read my earlier article ‘Revision of ISO 9001:2008 QMS Standard’ posted in this blog on 25 March 2013.


With best wishes,


Keshav Ram Singhal




I need Training or Consultancy help. Can you help?
Yes, we can certainly help you. We are expertise in implementation steps and can help you fast track your way to an effective and profitable QMS. We can provide you online training and/or consultancy help. If you need help in developing or implementing your ISO 9001:2008 QMS, please email us at keshavsinghalajmer@gmail.com giving details of your requirements.

Feedback is valuable
If you feel this article is informative or if you would like to provide us your feedback, do send us an email with your comments or write your comments in the space provided below the article. If you feel this blog could help your supplier, customer or other business associate, feel free to refer this blog to them.