MODULE TQM (Operation Management)

CHAPTER 9
QUALITY STANDARDS
Objectives:

1. Recognize the quality using Malcolm Baldridge and International

organization for Standardization ISO.
2. Differentiate between quality standard of Malcolm Baldridge and
International organization for Standardization ISO.

Quality Standards
 In essence, a standard is an agreed way of doing something. It could be about
making a product, managing a process, delivering a service or supplying materials.
 Standards are important in international trade because incongruent standards can
be barriers to trade, giving some organizations advantages in certain areas of the
world.
 Standard provide clear identifiable references that are recognized internationally
and encourage fair competition in free- market economies.
Quality Awards and Standards
MALCOLM BALDRIDGE
The Malcolm Baldridge Award is a United States quality award that covers an
extensive list of criteria evaluated by independent judges. The award is given to those
companies that productively dare and meet the requirements. The requirements and the
evaluation process should be very parallel to the Deming Prize system to be successful.
The award is named after the secretary of commerce under the Reagan administration;
Malcolm Baldrigde.
Criteria to become Baldridge Awardees
The evaluation for the award consists of meticulous set of criteria named the
Criteria for Performance Excellence with the intention to persuade firms to enhance their
competitiveness using an aligned approach to organizational performance management
with the following outcomes:
1. Delivery of increasingly improving vale, adding to market place success.
2. Enhancement of the general company performance and capabilities.
3. Learning on organization and personal level.
The criteria to address are categorized as:
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1. Leadership- examines how senior executives guide the organization and how the
organization addresses its responsibilities to the public and practice good
citizenship.
2. Strategic planning- examines hoe the organization sets strategic directions and
how it determines key action plans.
3. Customer focus- examines how organization determines requirements and
expectations of customers and markets; builds relationships with customers; and
acquires, satisfies, and retains customers.
4. Measurement, analysis and knowledge management- examines the
management effective use, analysis and improvement of data and information to
support key organization processes and the organization’s performance
management system.
5. Workforce focus- examines how the organization enables its workforce to
develop its full potential and how the workforce is aligned with the organization’s
objectives.
6. Process management- examines aspects of how key production/ delivery and
support processes are designed, managed and improved.
7. Results- examines the organization’s performance and improvement in its key
business areas; customer satisfaction, financial and marketplace performance,
human resources, supplier and partner performance, operational performance and
governance and social responsibility. The category also examines how the
organization performs relatively to competitors.

Evaluation process
The scoring of responses to Criteria Items and Award applicant feedback are
based on two evaluation dimensions namely process and results. The specific factors for
process are approach, deployment, learning, and integration, are described below;
1. Approach- refers to the methods used by an organization to address the Baldridge
Criteria Items requirements.
2. Deployment- refers to the extent to which an approach is applied in addressing
the requirements of the Baldridge Criteria Item. Deployment is evaluated on the
basis of the breadth and depth of application of approach to relevant work units
throughout the organization.
3. Learning- refers to new knowledge or skills acquired through evaluation, study,
experience and innovation. Organizational learning is achieved through research
and development, evaluation and improvement cycles, ideas and input from
employees, customers ideas and input, faculty, staff, students, patients, and other
stakeholders; best practice sharing; and benchmarking.
4. Integration- refers to the harmonization of plans, processes, information,
resources decisions, actions, results, and analysis to support key organization-
wide goals.
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ISO STANDARDS
The International Organization for Standardization (ISO) is an international
standard-setting body composed of representatives from various national standards
organizations.
The international Organization for Standardization (ISO) is non-governmental
network of national agencies whose purpose is the development of international
standards for business and government.

Different Types of ISO

 Quality management
The ISO 9000 family addresses various aspects of quality management and
contains some of ISO’s best known standards. The standards provide
guidance and tools for companies and organizations who want to ensure
that their products and services consistently meet customer’s requirements,
and that quality is consistently improved.
 Environmental management
ISO 14001:2004. This ISO standard is the basis of development of an
environmental management system (EMS). An EMS is a set of guidelines
and procedures developed by an organization to ensure compliance.
ISO 14004:2004. This ISO standard provides more specific information for
implementation and maintenance of an EMS, with the aim to continually
improve the plan based on its performance.
ISO 5001. This yet-to-be-released standard will address energy
management and ways to increase energy efficiency and reduce
environmental impact of organizations.
 Health and Safety
ISO 22000. This ISO standard sets global guidelines for food safety and
handling. Major corporations have embraced this standard, including Arla
Foods and Kraft Foods. Its aim is to focus on the entire food chain and
reduce hazards and safety issues such food-borne illnesses.
 Transportation
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ISO/TS 16949. This standard reviewed all areas of the automotive industry
supply chain.
ISO/PAS 30003: 2008. This standard looks at specific concerns within
shipping and marine technology.
 Social Responsibility
ISO 26000. This standard assures that business and organizations do not
operate in a vacuum. Their relationship to the society and environment in
which they operate is a critical factor in their ability to continue to operate
effectively.
ISO 26000:2010. This standard provides guidance rather than
requirements so it cannot be certified to unlike some other well-known ISO
standards. Instead, it helps clarify what social responsibility is.
 Energy Management
ISO 50001. Using energy efficiently helps organizations save money as well
as helping to conserve resources and tackle climate change.
ISO 50001:2011. This is based on the management system model of
continual improvement also used for other well-known standards such as
ISO 9001 or ISO 14001.
 Risk Management
ISO 31000. This standard is about the risk affecting organizations that can
have consequences in terms of economic performance and professional
reputation, as well as environmental, safety and social outcomes.
ISO 31000:2009. This standard offers principles and guidelines, provides
principles framework and a process for managing risk.
 Food and Safety Management
ISO 22000. The ISO 22000 family of International Standards addresses
food safety and management. The consequences of unsafe food can be
serious and ISO’s food safety management standards help organizations
identify and control food safety.
 Information Security Management
ISO/IEC 27001. The ISO 27000 family of standards helps organizations
keep information assets secure. Using this family of standards will help the
organization manage the security of assets such as financial information,
intellectual property, employee details or information entrusted to you by
third parties.
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 Occupational Health and Safety

ISO 45001. Over 63000 people die each day from work-related accidents
or diseases that nearly 2.3 million every year. The burden of occupational
injuries and diseases is significant, both for employers and the wide
economy, resulting in losses from early retirement, staff absence and rising
insurance premiums.
 Anti- Bribery management System
ISO 37001. This is the future anti-bribery management systems, specifies
a series of measures to help organizations prevent, detect and address
bribery. This include adopting an anti-bribery policy, appointing a person to
oversee anti-bribery compliance, training, risk assessments and due
diligence on projects and business associates, implementing financial and
commercial controls and instituting reporting and investigation procedures.
 Medical Devices
ISO 13485. Safety and quality are non-negotiable in the medical devices
industry. Regulatory requirements are increasingly stringent throughout
every step of a product’s life cycle, including service and delivery.

Registration Steps to become ISO Certified

1. Finding an ISO 9001 Registrar

There is a need to begin searching for an ISO registrar during 2 to 3 months
the company is still building its quality the quality system. Search can be done in
the ANSI- ASQ National Accreditation Board (ANAB) to select the registrar right
for the company.
2. Selecting an ISO Registrar
A company applying for registration should select a registrar that his
experience within the scope category of its specific industry, which can be found
also on the ANAB site.
3. Creating an ISO Application
A company and a registrar will agree on the application contract. This is an
important step of the ISO Registration Process because it defines the rights and
obligation of both parties, and includes liability issues, confidentiality and access
rights.
4. Conducting a Quality Document review
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The registrar will require a copy of the company quality manual and
procedures to verify that all the requirements of the standard are addressed.
5. Determining Pre-assessment Need
Though optional, this 2-4 weeks initial review of the system identifies any
significant omissions or weaknesses. It saves time and allows the registrar to
assess any issues and resolve logistics before the actual assessment audit.
6. Issuing an ISO Assessment
During the audit or physical onsite inspection of procedures in action, the
auditors will issue findings if they assess anything that doesn’t meet requirements
or nonconformities. In general, the flow of activities during the audit are as follows:
a) Opening Meeting- an introduction of the audit team and key personnel in
the company.
b) Brief tour of the Facility- keep it brief, the auditors just want to get general
feel for the layout and processes involved.
c) Additional review of documents- audit team members review
documentation for areas they will audit.
d) Examination- the audit is conducted, personnel are interviewed, and
objective evidence is collected to show the system has been effectively
implemented.
e) Daily review- at the end of each day or the beginning of the next, the audit
team reviews any issues identified during the assessment.
f) Closing Meeting- the audit team states their conclusion regarding the audit
and presents any findings or nonconformities that were identified along with
any observations they may have.
g) Audit Report issued- within a few weeks of the audit, the Registrar issues
the audit report. The report generally restates what was discussed in the
closing meeting.
Audit findings are usually called nonconformities and fall into one of two categories
depending in severity.
1. A Minor Nonconformance deals with minor infractions of procedures or
minor failures of the system in meeting the ISO 9001:2008 requirements.
These will not hold up the registration.
2. A Major Nonconformance deals with issues where nonconforming product
is likely to reach the customer or where there is a breakdown in the Quality
System that results in the system not being effective in meeting the
requirements of the standard. This will hold up the registration.

7. Completing ISO 9001 Registration

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After all of the findings are put into the ISO audit report and nonconformities
are addressed, the registering company has the option to register as ISO 9001
conformant. The company will receive a certificate and can also be listed in a
register, which the company can use to publicize its registration and use in
advertising.
8. Checking with Surveillance Auditor
To ensure that the system is maintained and that changes don’t result in
deficiencies in the system, registrars perform regular surveillances of the system.

For further discussion please refer to the link provided: Quality Standards
https://www.youtube.com/watch?v=EI2Mgrvq0Us
For further discussion please refer to the link provided ISO 9001
https://www.youtube.com/watch?v=FDyIcM-AFzU

Reference:
Total Quality Management (OBE)
Prof. Angelita Ong Camilar-Serrano,DBA(candidate