ISO 14000

Introduction
 After the success of the ISO9000 series of quality standards, the International
Standards Organization published a comprehensive set of standards for
environmental management. This series of standards is designed to cover the whole
area of environmental issues for organizations in the global marketplace.

History of ISO14000

 The ISO 14000 series emerged primarily as a result of the Uruguay round of the
GATT negotiations and the Rio Summit on the Environment held in 1992. While
GATT concentrates on the need to reduce non-tariff barriers to trade, the Rio Summit
generated a commitment to protection of the environment across the world. The
environmental field HAS seen a steady growth of national and regional standards.
The British Standards Institution has (BS7750) the Canadian Standards Association
has environmental management, auditing, eco-labelling and other standards, the
European Union has all of these plus the eco-management and audit regulations, ,
and many other countries (e.g. USA, Germany and Japan) have introduced eco-
labelling programs.

 After the rapid acceptance of ISO 9000, and the increase of environmental standards
around the world, ISO assessed the need for international environmental
management standards. They formed the Strategic Advisory Group on the
Environment (SAGE) in 1991, to consider whether such standards could serve to:

 Promote a common approach to environmental management similar to

quality management;
 Enhance organizations' ability to attain and measure improvements in
environmental performance; and
 Facilitate trade and remove trade barriers.
  In 1992, SAGE's recommendations created a new committee, TC 207, for
international environmental management standards. The committee and its sub-
committees include representatives from industry, standards organizations,
government and environmental organizations from many countries. The new series
of ISO14000 standards are designed to cover:

 environmental management systems

 environmental auditing
 environmental performance evaluation
 environmental labelling
 Life-cycle assessment
 environmental aspects in product standards

What is ISO 14000

 The ISO 14000 is a standard for environmental management systems that is

applicable to any business, regardless of size, location or income. The aim of the
standard is to reduce the environmental footprint of a business and to decrease the
pollution and waste a business produces. The most recent version of ISO 14001 was
released in 2004 by the (ISO) which has representation from committees all over the
world.

 The major objective of the ISO 14000 series of norms is "to promote more effective
and efficient environmental management in organizations and to provide useful and
usable tools - ones that are cost effective, system-based, flexible and reflect the best
organizations and the best organizational practices available for gathering,
interpreting and communicating environmentally relevant information". The intended
end result is the improvement of environmental performance.

 It offers source of guidance for introducing and adopting environmental management

systems based on the best universal practices, in the same way that the ISO 9000
series on quality management systems, which is now widely applied, represents a
tool for technology transfer of the best available quality management practices

Why have these standards?

 A set of international standards brings a world-wide focus to the environment,

encouraging a cleaner, safer, healthier world for us all. The existence of the
 standards allows organizations to focus environmental efforts against internationally
accepted criteria.
 At present many countries and regional groupings are generating their own
requirements for environmental issues, and these vary between the groups. A single
standard will ensure that there are no conflicts between regional interpretations of
good environmental practice.

What do the standards apply to?

 This is primarily for the company to decide, and to clearly document the extent of
coverage. However, limiting coverage to a small [inconsequential] area may provide
competitors with an ideal marketing opportunity.
 There does not appear to be a limit to the coverage of the environmental
management system in that it can include the organization's products, services,
activities, operations, facilities, transportation, etc.
 From a slightly different viewpoint, all of the elements in the previous sentence
should be considered for environmental impact resulting from current practices, past
practices and future practices, ......and should further be reviewed for their impact
under normal, abnormal and emergency conditions.

Who do the standards apply to ?

 The standards apply to all types and sizes of organizations and are designed to
encompass diverse geographical, cultural and social conditions. For ISO14001,
except for committing to continual improvement and compliance with applicable
legislation and regulations, the standard does not establish absolute requirements for
environmental performance. Many organizations, engaged in similar activities, may
have widely different environmental management systems and performance, and
may all comply with ISO14001.
Other ISO14000 Series Standards

 Other standards in the series are actually guidelines, many to help you achieve
registration to ISO 14001. These include the following:
 ISO 14004 provides guidance on the development and implementation of
environmental management systems
 ISO 14010 provides general principles of environmental auditing (now
superseded by ISO 19011)
 ISO 14011 provides specific guidance on audit an environmental
management system (now superseded by ISO 19011)
 ISO 14012 provides guidance on qualification criteria for environmental
auditors and lead auditors (now superseded by ISO 19011)
 ISO 14013/5 provides audit program review and assessment material.
 ISO 14020+ labelling issues
 ISO 14030+ provides guidance on performance targets and monitoring within
an Environmental Management System
 ISO 14040+ covers life cycle issues
 Of all these, ISO14001 is not only the most well known, but is the only ISO 14000
standard against which it is currently possible to be certified by an external
certification authority.

HACCP
What is HACCP?

 HACCP is a pro-active process control system by which food quality is ensured.

 HACCP principles, developed by the Codex Alimentarius of the World Health

Organization, demand that effective food safety systems are established through the
application of a systematic approach to hazard and risk analysis.

 The guiding principles of a HACCP system are

 Description of product

 Description of processes

 hazard analysis: identifying the potential hazards.

 risk analysis: defining 'critical control points' (CCP) and other areas requiring
attention

 control of the critical control points

 control of any points of attention, by general measures

Why is HACCP Important?

 HACCP is important because it prioritizes and controls potential hazards in food

production. By controlling major food risks, such as microbiological, chemical and
physical contaminants, the industry can better assure consumers that its products
are as safe as good science and technology allows. By reducing food borne hazards,
public health protection is strengthened.

What are the Major Food Hazards?

 While many public opinion studies report that consumers are concerned primarily
about chemical residues, such as from pesticides and antibiotics, these hazards are
nearly non-existent. The more significant hazards facing the food industry today are
microbiological contaminants, such as Salmonella, E. coli O157:H7, Listeria,
 Campylobacter, and Clostridium botulinum. HACCP is designed to focus on and
control the most significant hazards.

How Does HACCP Work in Food Production?

 There are seven principles, developed by the National Advisory Committee on

Microbiological Criteria for Foods, that serve as the foundation for a HACCP system.
They are:
1. Conduct a hazard analysis to identify potential hazards that could occur in the
food production process.
2. Identify the critical control points (CCPs) -- those points in the process where
the potential hazards could occur and can be prevented and/or controlled.
3. Establish critical limits for preventive measures associated with each CCP. A
critical limit is a criterion that must be met for each CCP. Where appropriate, critical
limits may reflect relevant FSIS regulations and FDA tolerances.
4. Establish CCP monitoring requirements to ensure each CCP stays within its
limit. Monitoring may require materials or devices to measure or otherwise evaluate
the process at CCPs.
5. Establish corrective actions if monitoring determines a CCP is not within the
established limits. In case a problem occurs, corrective actions must be in place to
ensure no public health hazard occurs.
6. Establish effective recordkeeping procedures that document the HACCP
system is working properly. Records should document CCP monitoring, verification
activities and deviation records.
7. Establish procedures for verifying that the HACCP system is working properly.
Verification procedures may include reviewing the HACCP plan, CCP records, critical
limits as well as conducting microbial sampling. Both plant personnel and FSIS
inspectors will conduct verification activities.

When HACCP is start to been used?

 It was first used in the 1960s by the Pillsbury Company to produce the safest and
highest quality food possible for astronauts in the space program. The National
Academy of Sciences, National Advisory Committee for Microbiological Criteria for
 Foods, and the Codex Alimentarius have endorsed HACCP as the best process
control system available today.

How can HACCP certification benefit the organization?

 Certification to the HACCP system helps create a systematic framework in which
organizations reduce risk and drive continual improvement.

 Taking a formalized approach to assuring food safety helps a company to

demonstrate commitment by meeting the demands of legislation and customers.

How Can Consumers Use HACCP?

 Consumers can implement HACCP-like practices in the home by following proper

storage, handling, cooking and cleaning procedures.

 From the time a consumer purchases meat or poultry from the grocery store to the
time they cook and serve a meal, there are many steps to take to ensure food safety.

 Examples include properly refrigerating meat and poultry, keeping raw meat and
poultry separate form cooked and ready-to-eat foods, thoroughly cooking meat and
poultry, and refrigerating and cooking leftovers to prevent bacterial growth
 GMP
What is GMP?

 Current Good Manufacturing Practice regulations enforced by the US Food and Drug
Administration (FDA).
 It provide for systems that assure proper design, monitoring, and control of
manufacturing processes and facilities. 
 GMP regulations assure the identity, strength, quality, and purity of drug products by
requiring that manufacturers of medications adequately control manufacturing
operations. Including:
 Establishing strong quality management systems.
 Obtaining appropriate quality raw materials.
 Establishing robust operating procedures.
 Detecting and investigating product quality deviations.
 Maintaining reliable testing laboratories.
 This formal system of controls at a pharmaceutical company, if adequately put into
practice, helps to prevent instances of contamination, mix-ups, deviations, failures,
and errors.
 The GMP requirements were established to be flexible in order to allow each
manufacturer to decide individually how to best implement the necessary controls by
using scientifically sound design, processing methods, and testing procedures.

 The flexibility in these regulations allows companies to use modern technologies and

innovative approaches to achieve higher quality through continual improvement.

 It is important to note that GMP are minimum requirements.

    Many pharmaceutical manufacturers are already implementing comprehensive,

modern quality systems and risk management approaches that exceed these

minimum standards. 

Why GMP is important?

 Most instances testing is done on a small sample of a batch (for example, a drug
manufacturer may test 100 tablets from a batch that contains 2 million tablets), so
that most of the batch can be used for patients rather than destroyed by testing. 

 Therefore, it is important that drugs are manufactured under conditions and practices
required by the GMP regulations to assure that quality is built into the design and
manufacturing process at every step.

How GMP requirements help to assure the safety and efficacy

of drug products?

 make sure facilities that are in good condition,

 make sure the equipment that is properly maintained and calibrated,

 Make sure the employees who are qualified and fully trained, and processes that are

reliable and reproducible.

How does FDA determine if a company is complying with GMP

regulations?

 FDA inspects pharmaceutical manufacturing facilities worldwide using scientifically

and GMP- trained individuals whose job it is to evaluate whether the company is

following the GMP regulations. 

 FDA also relies upon reports of potentially defective drug products from the public

and the industry.  

 FDA will often use these reports to identify sites for which an inspection or

investigation is needed. 

What can FDA do to protect the public when there are GMP

violations?

 If the failure to meet GMPs results in the distribution of a defective drug, the company

may subsequently recall that product.

 This protects the public by removing these drugs from the market. 

 While FDA cannot force a company to recall a drug, companies will usually recall

voluntarily or at FDA’s request.  If a company refuses to recall a drug, FDA can warn

the public and could seize the drugs that are on the market.
 Even if the drugs are not defective, FDA can bring a seizure or injunction case in

court to address GMP violations.  When FDA brings a seizure case, the agency asks

the court for an order that allows federal officials to take possession of “adulterated”

drugs and destroy them.  This enables FDA to immediately prevent a company from

distributing those drugs to consumers.

 FDA can also bring criminal cases because of GMP violations, seeking fines and jail

time.