ISO Working on Energy Management Standard

The future ISO 50001 will establish an energy management framework for industrial plants, or entire organizations.


ISO: Geneva) -- The first meeting of ISO’s new project committee PC 242, which is to develop an international standard on energy management, was held Sept. 8-10, 2008 in Washington, D.C.

The future ISO 50001 will establish an energy management framework for industrial plants, commercial facilities, or entire organizations. Targeting broad applicability across national economic sectors, the standard could influence up to 60 percent of the world’s energy.

The meeting was attended by delegates from the ISO national member bodies of 25 countries, coming from all regions of the world, as well as representation from the United Nations Industrial Development Organization (UNIDO), a liaison to PC 242. All participating countries have existing energy management activities and a strong interest in developing a harmonized solution at the international level.

As part of the proceedings, delegates described their various initiatives in detail. A presentation was given by UNIDO on preparatory work the organization has carried out to support the ISO process through researching energy management needs in developing countries.

This gave PC 242 an insight into the different policies and situations around the world that need to be taken into account in the development of a globally relevant international standard for energy management.

Excellent progress was made in the technical discussions, and a first working draft was created. A major point of discussion was the need to ensure compatibility with the existing suite of ISO management system standards. The committee made a key decision to base this draft on common elements found in all of ISO’s management system standards.

This ensures maximum compatibility with key standards such as ISO 9001 for quality management and ISO 14001 for environmental management.

The project committee is fully committed to an ambitious schedule and aims to have ISO 50001 ready for publication by the end of 2010.

"This first meeting of PC 242 marks the launch of a new global approach to systematically address energy performance in organizations –- pragmatically addressing energy efficiency and related climate change impacts," says ISO Secretary-General Alan Bryden. "It is fully in line with and supportive of the global mobilization on these major challenges, and with the IEA-ISO position paper on the contribution of International Standards."

For more information, visit www.iso.org.

source: qualitydigest.com

SQF, Certification Levels

The SQF Codes: Three certification levels

Level 1
Food Safety Fundamentals. Indicates that prerequisite programs and fundamental food safety controls have been implemented to provide a sound foundation for the further development of the Organization’s management system.

Level 2
Food Safety Plans Incorporates all Level 1 system requirements and indicates that a food safety risk analysis of the product and its associated process has been completed to identify the hazards and the actions taken to eliminate, prevent or reduce their occurrence.

Level 3
Comprehensive Food Safety and Quality Management Systems Development. Incorporates all Level 1 and Level 2 system requirements and indicates that a food quality risk assessment of the product and its associated process have been completed, that the actions taken to prevent the incidence of poor quality and the remaining quality management systems procedures have been implemented.

* The Global Food Safety Initiative (GFSI) is coordinated by CIES - The Food Business Forum, launched May 2000.

Safe Quality Food (SQF)

•The Safe Quality Food (SQF) is a quality program recognized by the Global Food Safety Initiative (GFSI)*, an organization representing over 70% of food retail revenue worldwide. The Food Marketing Institute (FMI) manages the SQF program.
•Currently, there are two SQF Codes: SQF 1000 for farmers / producers and SQF 2000 for food manufacturers and distributors.
•SQF 1000 and 2000 Codes are based on the principles of Hazard Analysis at Critical Control Point (HACCP), Codex, ISO and Quality Management Systems.
•SQF Certification to these codes gives assurance to retailers that the food from suppliers has been produced, prepared and handled according to internationally recognized standards.

Defending the food chain

Created in response to the complicated nature of the global food industry and the mass of national regulations and standards that sprang up to try and police it, ISO 22000 has now been adopted by organizations from numerous food industry sectors across the globe. It provides a global management system framework for certification that crosses borders as easily as the produce whose safety it strives to ensure, while widening the scope of food safety management to support industries and smaller organizations that might not have had the resources or motivation to seek certification in the past.

As an evolution of other standards, ISO 22000:2005 Food safety management systems. Requirements for any organization in the food chain uses generally recognised methods of food safety management such as interactive communication across the food chain, system management, control of hazards through prerequisite programmes and HACCP plans, and continual improvement and updating of the management system.

In July 2006, a survey of 44 national standards bodies, found that only five countries had yet to adopt ISO 22000 as a national standard. Of these, Canada was waiting to assess the feedback of a wide group of stakeholders due to report back that same month before making a decision to go ahead, while the rest - Japan, Qatar, Senegal and Trinidad & Tobago - were yet to make a decision on adoption. Half of the countries surveyed said they expected to have begun certifying early adopters of the standard before the end of this year.

One such early adopter of ISO 22000 as a food safety management system is confectioner Henri Charpentier, which became one of the first food companies in Japan to achieve ISO 22000 certification earlier this year. The company, famous in Japan for its "fancies" and Madeline cakes, upgraded from its existing HACCP-based food safety system to ISO 22000 as part of a general programme of improvement rather than in reaction to a particular incident or catalyst such as a customer requirement.

The firm, which used BSI Management Systems Japan to perform its audit and certification - one of the first independent certification bodies to be able to deliver ISO 22000 certification in the country - is now on a path of continuous improvement in their food safety programme. Because ISO 22000 governs food safety rather than quality, which remains very much in the hands of the producer as a key element in its business strategy, Henri Charpentier can now add food safety to its other unique selling points of great taste and design.

"We went through the assessment by BSI Japan believing that they represent our customers," says Koji Yoshida, assistant manager of Henri Charpentier's Operational Audit Office and a member of the ISO 22000 Steering Task Force. "Therefore, we welcomed any observations or comments for improvement from BSI, as those comments are easier for us to absorb and because observations by BSI Japan are more persuasive than those made by people within our company."

Compatible ingredients

While ISO 22000 has strong credentials as a stand-alone standard, it is also designed to be fully integrated with ISO 9001:2000. This means that, as well as cutting down on administration costs by minimizing overlap between the two, ISO 22000 is able to build on the familiarity earned by the popular ISO 9000 series to help food businesses expand their commitment to standards and continuous improvement in food safety.

This certainly proved to be the case with Hungarian food processor Moraprizma Szovetkezet, which was running ISO 9001 and HACCP at its plant in the Moraholm region of Hungary before deciding to become one of the first organizations in the country to register to ISO 22000.

The company, which was established to process vegetable and fruit crops in the region, produces fresh salad mix and vegetable pieces in various forms of packaging. Customers include the hospitality industry and retailers such as Tesco - the world's third largest supermarket and retail chain - and French hypermarket group Cora.

The company chose ISO 22000 because of the ease with which it consolidates ISO 9001 and HACCP, its certification formula and the fact it is an internationally recognized standard for food safety management.

International recognition also proved a vital ingredient for Hong Kong's Health Affluence Group. A subsidiary of Imperial Bird's Nest International, one of Hong Kong's leading importers of bird's nests and a wholesaler and retailer with operations in Hong Kong and Canada, Health Affluence manufactures a range of instant bird's nest soup products and has already gained ISO 22000 certification at its Yuen Long plant in Hong Kong.

Certification was attained after BSI carried out an assessment to compare Health Affluence's existing food safety management systems against ISO 22000. Following this, BSI conducted a three-day audit to verify the group's systems and controls against the standard.

A wider menu

One breakthrough for ISO 22000 is that it provides support firms - be they in the growing packaging, storage or transportation worlds - with a means to gain certification. This was one deciding factor for UK packaging firm Bemis Swansea Ltd, which achieved its ISO 22000 certification through BSI earlier this year. Bemis is one of the largest packaging companies in the Americas and Mike Bird, plant manager at its Swansea UK site, underlines the benefits he sees ISO 22000 certification will bring to his business going forward: "This significant accomplishment demonstrates our company's continued commitment to deliver products that meet customer requirements. The certification will now extend the scope of our current food safety management system by enabling us to demonstrate the result of our activities to customers, suppliers and other interested organizations worldwide."

As an addition to the portfolio of food standards already available, ISO 22000 will hopefully minimize the risk faced by the public to the infrequent yet serious contamination scandals that pose such a threat to the industry. Its take-up suggests that, when it comes to managing food safety, many companies understand the important role that ISO 22000 plays.

Source: businessstandards.com/Articles

PAS 220:2008

Publicly Available Specification (PAS) 220 specifies requirements for prerequisite programmes to assist in controlling food safety hazards. PAS 220 should be used in conjunction with BS EN ISO 22000. BS EN ISO 22000 sets out specific food safety requirements for organizations in the food chain. This PAS is intended to be used to support management systems designed to meet the requirements specified in BS EN ISO 22000. It sets out the detailed requirements for those programmes.

This PAS does not duplicate requirements given in BS EN ISO 22000 and is intended to be used in conjunction with BS EN ISO 22000, not in isolation.

PAS 220 specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRP) to assist in controlling food safety hazards. It applies to all organizations, regardless of size or complexity. It also applies to all who are involved in the manufacturing step of the food chain and wish to implement PRP in such a way as to address the requirements specified in BS EN ISO 22000.

PAS 220 is not designed or intended for use in other parts of the food supply chain. Food manufacturing operations are diverse and not all of the requirements specified in this PAS apply to an individual establishment or process.

PAS 220 specifies detailed requirements to be considered including:

a) Construction and layout of buildings and associated utilities
b) Layout of premises, including workspace and employee facilities
c) Supplies of air, water, energy and other utilities
d) Supporting services, including waste and sewage disposal
e) Suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance
f) Management of purchased materials
g) Measures for the prevention of cross contamination
h) Cleaning and sanitizing
i) Pest control
j) Personnel hygiene.

It also adds other aspects that are considered relevant to manufacturing operations:
i) Rework
ii) Product recall procedures
iii) Warehousing
iv) Product information and consumer awareness
v) Food defence, biovigilance and bioterrorism.

Contents:

Foreword
Introduction
Scope
Normative references
Terms and definitions
Construction and layout of buildings
Layout of premises and workspace
Utilities – air, water, energy
Waste disposal
Equipment suitability, cleaning and maintenance
Management of purchased materials
Measures for prevention of cross contamination
Cleaning and sanitizing
Pest control
Personnel hygiene and employee facilities
Rework
Product recall procedures
Warehousing
Product information/consumer awareness
Food defence, biovigilance and bioterrorism
Bibliography

Source: bsigroup.com

A revolution in international food safety standards?

Safety in the food supply chain is of paramount importance. And yet there hasn't been a single, universally accepted, end-to-end food safety standards-based solution in place: until now. Oliver Cann finds out more.

Early in 2009, the Food and Drug Administration (FDA) in the US announced that it had found widespread salmonella contamination at a large peanut processing plant based in Georgia. Despite the fact that the plant itself was not a major player, its products - in particular, its peanut paste - tainted an entire supply chain.

According to the FDA, as of April 2009, more than 2,100 products in 17 categories had been recalled by more than 200 companies, and the list continues to grow. The plant at the heart of the incident has filed for bankruptcy and the salmonella outbreak itself struck more than 500 people, extending as far as Canada. Of those affected, at least six were reported to have died.

Strengthening the chain

The food supply chain on which we all rely extends farther and goes deeper than ever before. For example, a piece of fruit grown in Africa can be on grocery store shelves in Europe within 24 hours of harvest. Coffee from Asia wends its way to shops across Europe. Lamb from New Zealand is enjoyed across the UK and North America.

With such a far-reaching supply chain in place, carrying such an essential product as food, having the proper security and safety measures in place is vital.

A robust, independently verified food management system could make a real difference by improving a food organization's flexibility, readiness and ultimate viability in the face of an ever-changing risk environment. This is particularly true when set against the backdrop of current economic pressures, when there is a temptation to cut corners. Under the circumstances, the need for food safety has never been greater. And yet, to this day, there has not been a unified, internationally accepted food safety management solution in place to do the job.

Good progress has been made by the industry to date. It was concern over potential risks in the food supply chain that prompted the creation of a number of early food safety sector initiatives and standards, including HACCP and the BRC and IFS retailer driven food manufacturing standards along with EuroGAP for the pre-farm gate sector. But it was not until the publication of international food safety management system standard ISO 22000 in 2005 that there was a single standard covering the entire food supply chain.

Adoption of ISO 22000 throughout all sectors of the industry has been relatively poor. In particular, in the highly influential food manufacturing sector, it quickly became apparent that ISO 22000 had limitations. From a technical perspective, the requirements on prerequisite programmes (PRPs) were not deemed to be specific enough to meet stakeholder needs.

Another limitation revolved around the position of the internationally recognized organization, the Global Food Safety Initiative (GFSI). Without the appropriate PRPs and scheme ownership, ISO 22000 could not be benchmarked by the GFSI and given the same approval as other standards.

"The food safety landscape is very straight-forward," says Steve Mould, worldwide quality management systems manager at Kraft Foods. "Food safety standards need to be recognized by the GFSI but ISO 22000 could not on its own. ISO 22000 gives lists of PRP topics to consider, but because it covers the whole of the food industry, it does not include PRPs for each step: otherwise it would need to be the size of an encyclopaedia. Something else was needed to fill the gap and give ISO 22000 the support that was needed."


PAS 220: supporting ISO 22000


Publicly Available Specification (PAS) 220 is a new complementary standard to ISO 22000. It has been designed to address the technical limitations around PRPs in ISO 22000 for the food manufacturing sector.

PAS 220:2008 Prerequisite programmes on food safety for food manufacturing was developed by BSI and sponsored by Danone, Kraft Foods, Nestlé and Unilever through the Confederation of the Food and Drink Industries of the EU (CIAA). Other stakeholders involved in the development process included representatives from the Food and Drink Federation (FDF), McDonald's, General Mills Europe, and certification bodies.


FSSC 22000: the icing on the cake


FSSC 22000 (Food Safety System Certification 22000) is a new global food safety scheme which brings together ISO 22000 and PAS 220 certification for the food manufacturing industry.

"While existing schemes have a reasonable consistency of requirements, there was no true consistency of auditing and certification," says Mould, who was also the technical author of PAS 220. "Food safety schemes on the market today tend to be owned by stakeholders in the food supply chain. By moving to an independently owned certification scheme, we saw that we would be able to minimize system and audit variations based on geography, sector and customer, and reduce barriers to trade across the chain."

"An independent board comprising representatives from manufacturing, retail, consumer organizations and other international bodies is responsible for the content and management of FSSC 22000," says Cor Groenveld, chairman of the Foundation for Food Safety (FFS), the not-for-profit organization responsible for the scheme. "The scheme's independent ownership should make it attractive to all stakeholders."

The scheme has been designed to meet the GFSI's benchmarking requirements and a decision by the GFSI board will take place in May 2009 as to whether FSSC 22000 is accepted as an approved certification scheme.

Once the GFSI approves FSSC 22000, Paul Whitehouse, quality manager at Unilever and another member of the PAS 220 steering group, believes one impact on the food manufacturing industry could be cost savings and new opportunities for SMEs and niche producers.

"Food safety is a destination; there are a number of routes and you choose one that best suits your organization," he says. "Given that companies are already used to working with ISO standards and are familiar with the risk and management systems based approach adopted by ISO 22000 and PAS 220, they may find it easier to align with these than with other standards."

"A GFSI-approved FSSC 22000 scheme could bring more food manufacturers into the fold, as well as encouraging other interested parties along the food chain to adopt similar PRP-based approaches," says Joy Franks, the global product manager at BSI responsible for food safety.

"The majority of the ISO 22000 certificates that have been issued to date come from outside the manufacturing sector," she says. "The driver was never there for manufacturers because of the PRP issues that are so central to their requirements. This has been addressed by ISO 22000 and PAS 220 and it's quite conceivable that, in a similar way, ISO 22000 plus new PAS 220 type standards could be used as a framework for other food sectors, for example retail, foodservice and packaging. If this was to become the case, then we'd have a more integrated approach to food safety management, which would be a great step forward for the industry and, ultimately, the consumer."

With seven of the world's largest supermarket chains already committed to accepting any scheme recognized by the GFSI, there is widespread optimism that FSSC 22000 will join the GFSI recognized list, says Groenveld: "The development of the scheme and PAS 220 has been a positive process, with international and broad industry input. Now we are just waiting for the GFSI approval and then we will hopefully see a significant impact in the industry."

"We are heading towards a truly international food safety standard, one that covers the whole of the supply chain," says Mould. "This will make the supply chain safer. If every aspect of the food industry adopted one international standard and operated under the same management system structure, then we will have more consistency and enhanced safety throughout the supply chain. With ISO 22000 and PAS 220 coming together under FSSC 22000, we're in a position for this to happen and we may well see a revolution in the food industry."

Source: businessstandards.com/Articles

Six Sigma Training Vs Total Quality Management

Six Sigma Training has not been developed with the intention to replace TQM.

It was developed by some of the most gifted CEO s with a view to make their business successful to the maximum extent possible - with the help of the tools and techniques of the quality profession.

Then What Is The Difference?

The difference between Six Sigma Training and TQM is best described in a word - 'management'. TQM provides broad guidelines for management. TQM is often related to the development and deployment and maintenance of organizational systems required by various processes.

Six Sigma is more for the purpose of continuous quality improvements for achieving zero defects. TQM helps in improving quality, but cannot take it ahead to continuous improvement. One major difference is visible in the approach.

TQM is more about conformance to internal requirements. Six Sigma focuses on continuous improvement and reduction in defects. The Six Sigma project is driven by the benefits from the viewpoint of the stakeholders, customers, shareholders and employees.

The outcome for both the systems is the same, achievement of better quality products. Six Sigma, however, has an edge here. It focuses on a reduction in defects and satisfying the specifications of the customers. Additionally, Six Sigma Training also helps reduce operational costs.

It achieves this by reduction in cycle time, reduction in defects and cost savings - but not at the cost of the quality and value of the product. Costs that provide no value to the customers are eliminated. Such costs may be those incurred due to waste.

TQM is generally an initiative taken up at individual operational levels, and may not be within the same processes. Six Sigma, on the other hand, aims at improving all operations in a single business process. For such projects, skilled and certified professionals are required such as Black Belts and Green Belts.

There are some team members who may be working part-time on their regular activities along with these projects. They aim at achieving the strategic goals and objectives and aligning the projects to the organizational goals. TQM projects do not necessarily need any specialists. These activities can be managed by non-dedicated managers along with their regular workloads.

Six Sigma team members work temporarily on such projects. The TQM goals are set by the quality department and are based on the assumption that the criteria are good for the quality as well as the organization. They are projects motivated by quality philosophy and undertaken by quality professionals.

Six Sigma projects start with a pre-planned project charter and with an outline of targets, highlighting prospective financial benefits and savings. Very often, organizations have implemented TQM projects without any idea of the financial benefits. The focus of TQM is on quality and performing to the standards, whereas Six Sigma focus is on strategic goals - and the metrics are based on these objectives and goals.

There are significant differences between TQM and Six Sigma - and though some tools and techniques of TQM and Six Sigma are similar, Six Sigma often has a distinct use for these tools. It seems as if Six Sigma will be more popular and achieve more that TQM.

Source: ezinearticles.com/?Six-Sigma-Training-Vs-Total-Quality-Management

Benefit of ISO 22000

Introduction

In order to understand the significance of ISO 22000 e must first understand what ISO 22000 is about and how is it applicable to the food industry. To achieve these objectives we must ask the following questions:

What ISO 22000 means?

ISO 22000 means consensus agreements between all the economic stakeholders concerned: suppliers; users; government regulators; other interest groups, such as consumers

How ISO 22000 benefit society?

For businesses, the widespread adoption of ISO 22000 means that suppliers can base the development of their products and services on specifications that have wide acceptance in their sectors;

This, in turn, means that businesses using ISO 22000 are increasingly free to compete on many more markets around the world

How ISO 22000 benefit consumers?

For consumers:

1. Conformity of products and services to International Standards

2. Provides assurance about:

:: quality

:: safety

:: reliability

How ISO 22000 benefit trade officials?

For trade officials negotiating the emergence of regional and global markets, IS0 22000 create “a level playing field” for all competitors on those markets;

The existence of divergent national or regional standards can create technical barriers to trade, even when there is political agreement to do away with restrictive import quotas and the like;

International Standards are the technical means by which political trade agreements can be put into practice

How ISO 22000 benefit developing countries?

For developing countries, ISO 22000 represents an international consensus and constitute an important source of technological know-how;

By defining the characteristics that products and services will be expected to meet on export markets;

International Standards give developing countries a basis for making the right decisions when investing their scarce resources and thus avoid squandering them

How ISO 22000 benefits everyone?

ISO 22000 can contribute to the quality of life in general by:

-ensuring safe food

-reducing foodborne diseases

-better quality and safer jobs in the food industry

-better utilization of resources

-more efficient validation and documentation of

techniques, methods and procedures

-increased profits

-increased potential for economic growth and development

How ISO 22000 benefit governments?

For governments, ISO 22000 provides:

-technological and scientific know-how

-bases for developing health, safety and environmental legislation

-education of food regulatory personnel

How ISO 22000 benefit governments?

-certification or registration

-international acceptance of standards used globally

-economic benefits

-social benefits

-trade liberalization

-food quality

-food safety

-food security

What are the benefits of ISO 22000 for other stakeholders?

Confidence that organizations implementing ISO 22000 have the ability to identify and control food safety hazards;

International in scope;

Provides potential for harmonization of national standards;

Provides a reference for the whole food chain;

Provides a framework for third party certification;

What are the benefits of ISO 22000 for other stakeholders?

Fills a gap between ISO 9001:2000 and HACCP;

Contributes to a better understanding and further development of Codex HACCP;

Auditable standards with clear requirements;

System approach rather than product approach;

Suitable for regulators

Summary of benefits of ISO 22000

More efficient and dynamic food safety hazard control;

Systematic management of prerequisite programmes;

Valid basis for taking decisions;

Increased due diligence;

Control focused on what is necessary;

Saves resources by reducing overlapping system audits;

Organizes and targets communication among partners;

Resource optimization;

Improves documentation;

Better planning, less post-process verification

Conclusions

Food safety is related to the presence of and levels of food-borne hazards in food at the point of consumption. As food safety hazards may be introduced at any stage of the food chain, adequate control throughout the food chain is essential. Thus, food safety is a joint responsibility of all parties participating in the food chain;

Failures in food supply can cause human suffering, death, poor reputation, violations, poor nutrition, poor quality products and decreased profits;

ISO 22000 ensures integrity of food supply chain by minimizing food-borne hazards throughout the food chain by ensuring that there are no weak links;

It therefore makes good scientific sense for those who are involved in food processing, manufacturing, storage, distribution of food and food products to adopt and implement ISO 22000;

ISO 22000 for food safety management systems is intended to provide food safety and security;

ISO 22000 can be applied on its own or in combination with other management system standards such as ISO 9001:2000

Source: wahyuhidayati.wordpress.com/2009/03/18/benefit-of-iso-22000

ISO14001:2004

ISO14001:2004

Personal Hygiene

Personal hygiene pertains to hygiene practices performed by an individual to care for one’s bodily health and well being through cleanliness. Motivations for personal hygiene practice include reduction of personal illness, healing from personal illness, optimal health and sense of well being, social acceptance and prevention of spread of illness to others.

Personal hygiene practices include: seeing a doctor, seeing a dentist, regular washing (bathing or showering) of the body, regular hand washing, brushing and flossing of the teeth, basic manicure and pedicure, feminine hygiene and healthy eating. Personal grooming extends personal hygiene as it pertains to the maintenance of a good personal and public appearance which need not necessarily be hygienic.
Personal hygiene is achieved by using personal hygiene products including: soap, hair shampoo, hair conditioner, toothbrushes, tooth paste, cotton swabs, deodorant, chapstick, cream, lotion, facial tissue, hair clippers, nail clippers, mouthwash, nail files, skin cleansers, razors, shaving cream, skin cream and toilet paper. Other personal hygiene and grooming products can be used to improve health and well being

Food Quality

Food quality is the quality characteristics of food that is acceptable to consumers. This includes external factors as appearance (size, shape, colour, gloss, and consistency), texture, and flavour; factors such as federal grade standards (e.g. of eggs) and internal (chemical, physical, microbial).Food quality is an important food manufacturing requirement, because food consumers are susceptible to any form of contamination that may occur during the manufacturing process. Many consumers also rely on manufacturing and processing standards, particularly to know what ingredients are present, due to dietary, nutritional requirements (kosher, halal, vegetarian), or medical conditions (e.g., diabetes, or allergies).Besides ingredient quality, there are also sanitation requirements. It is important to ensure that the food processing environment is as clean as possible in order to produce the safest possible food for the consumer. A recent example of poor sanitation recently has been the 2006 North American E. coli outbreak involving spinach, an outbreak that is still under investigation.Food quality also deals with product traceability, e.g. of ingredient and packaging suppliers, should a recall of the product be required. It also deals with labeling issues to ensure there is correct ingredient and nutritional information.

Hygiene

Hygiene, refers to the set of practices associated with the preservation of health and healthy living. Hygiene is a concept related to medicine as well as to personal and professional care practices related to most aspects of living although it is most often associated with cleanliness and preventative measures. In medicine, hygiene practices are employed to reduce the incidence and spreading of disease. Other uses of the term hygiene appear in phrases including: personal hygiene, domestic hygiene, dental hygiene, and occupational hygiene and is frequently used in connection with public health. The term "hygiene" is derived from Hygieia, the Greek goddess of health, cleanliness and sanitation. Hygiene is also the name of the science that deals with the promotion and preservation of health, also called hygienics. Hygiene practices vary widely and what is considered acceptable in one culture might not be acceptable in another.

Risk Assessment

Risk assessment consists in an objective evaluation of risk in which assumptions and uncertainties are clearly considered and presented. Part of the difficulty of risk management is that measurement of both of the quantities in which risk assessment is concerned - potential loss and probability of occurrence - can be very difficult to measure. The chance of error in the measurement of these two concepts is large. A risk with a large potential loss and a low probability of occurring is often treated differently from one with a low potential loss and a high likelihood of occurring. In theory, both are of nearly equal priority in dealing with first, but in practice it can be very difficult to manage when faced with the scarcity of resources, especially time, in which to conduct the risk management process. Expressed mathematically,
Financial decisions, such as insurance, express loss in terms of dollar amounts. When risk assessment is used for public health or environmental decisions, loss can be quantified in a common metric,such as a country's currency, or some numerical measure of a location's quality of life. For public health and environmental decisions, loss is simply a verbal description of the outcome, such as increased cancer incidence or incidence of birth defects. In that case, the "risk" is expressed as:
If the risk estimate takes into account information on the number of individuals exposed, it is termed a "population risk" and is in units of expected increased cases per a time period. If the risk estimate does not take into account the number of individuals exposed, it is termed an "individual risk" and is in units of incidence rate per a time period. Population risks are of more use for cost/benefit analysis; individual risks are of more use for evaluating whether risks to individuals are "acceptable"

The Seven HACCP Principles

Hazard Analysis and Critical Control Points (HACCP) is a process control system designed to identify and prevent microbial and other hazards in food production.
The Seven HACCP Principles

Principle 1: Conduct a hazard analysis.
Plants determine the food safety hazards identify the preventive measures the plant can apply to control these hazards.

Principle 2: Identify critical control points.
A critical control point (CCP) is a point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to an acceptable level. A food safety hazard is any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

Principle 3: Establish critical limits for each critical control point.
A critical limit is the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level.

Principle 4: Establish critical control point monitoring requirements.
Monitoring activities are necessary to ensure that the process is under control at each critical control point. FSIS is requiring that each monitoring procedure and its frequency be listed in the HACCP plan.

Principle 5: Establish corrective actions.
These are actions to be taken when monitoring indicates a deviation from an established critical limit. The final rule requires a plant's HACCP plan to identify the corrective actions to be taken if a critical limit is not met. Corrective actions are intended to ensure that no product injurious to health or otherwise adulterated as a result of the deviation enters commerce.

Principle 6: Establish record keeping procedures.
The HACCP regulation requires that allplants maintain certain documents, including its hazard analysis and written HACCP plan, and records documenting the monitoring of critical control points, critical limits, verification activities, and the handling of processing deviations.

Principle 7: Establish procedures for verifying the HACCP system is working as intended.

ISO 9001 Vs ISO 22000

In comparison with ISO 9001, the standard is a more procedural orientated guidance than a principle based one. Apart from that, ISO 22000 is an industrial-specific risk management system for any type of food processing and marketing, which can be closely incorporated with the quality management system of ISO 9001

Six Sigma Methods

Six Sigma has two key methods: DMAIC and DMADV, both inspired by Deming's Plan-Do-Check-Act Cycle. DMAIC is used to improve an existing business process; DMADV is used to create new product or process designs.

DMAIC
The basic method consists of the following five steps:

Define high-level project goals and the current process.
Measure key aspects of the current process and collect relevant data.
Analyze the data to verify cause-and-effect relationships. Determine what the relationships are, and attempt to ensure that all factors have been considered.
Improve or optimize the process based upon data analysis using techniques like Design of experiments.
Control to ensure that any deviations from target are corrected before they result in defects. Set up pilot runs to establish process capability, move on to production, set up control mechanisms and continuously monitor the process.

DMADV
The basic method consists of the following five steps:

Define design goals that are consistent with customer demands and the enterprise strategy.
Measure and identify CTQs (characteristics that are Critical To Quality), product capabilities, production process capability, and risks.
Analyze to develop and design alternatives, create a high-level design and evaluate design capability to select the best design.
Design details, optimize the design, and plan for design verification. This phase may require simulations.
Verify the design, set up pilot runs, implement the production process and hand it over to the process owners.
DMADV is also known as DFSS, an abbreviation of "Design For Six Sigma".

Source: en.wikipedia.org/wiki/Six_Sigma

Sigma levels

Short-term sigma levels correspond to the following long-term DPMO values (one-sided):

1 sigma = 690,000 DPMO = 31% efficiency
2 sigma = 308,000 DPMO = 69.2% efficiency
3 sigma = 66,800 DPMO = 93.32% efficiency
4 sigma = 6,210 DPMO = 99.379% efficiency
5 sigma = 230 DPMO = 99.977% efficiency
6 sigma = 3.4 DPMO = 99.9997% efficiency

These figures assume that the process mean will shift by 1.5 sigma towards the side with the critical specification limit some time after the initial study determining the short-term sigma level. The figure given for 1 sigma, for example, assumes that the long-term process mean will be 0.5 sigma beyond the specification limit, rather than 1 sigma within it, as it was in the short-term study.

Source: en.wikipedia.org/wiki/Six_Sigma

Origin and meaning of the term "six sigma process"

Sigma (the lower-case Greek letter σ) is used to represent the standard deviation (a measure of variation) of a statistical population. The term "six sigma process" comes from the notion that if one has six standard deviations between the process mean and the nearest specification limit, there will be practically no items that fail to meet specifications. This is based on the calculation method employed in process capability studies.

In a capability study, the number of standard deviations between the process mean and the nearest specification limit is given in sigma units. As process standard deviation goes up, or the mean of the process moves away from the center of the tolerance, fewer standard deviations will fit between the mean and the nearest specification limit, decreasing the sigma number and increasing the likelihood of items outside specification.

Role of the 1.5 sigma shift

Experience has shown that in the long term, processes usually do not perform as well as they do in the short. As a result, the number of sigmas that will fit between the process mean and the nearest specification limit is likely to drop over time, compared to an initial short-term study. To account for this real-life increase in process variation over time, an empirically-based 1.5 sigma shift is introduced into the calculation. According to this idea, a process that fits six sigmas between the process mean and the nearest specification limit in a short-term study will in the long term only fit 4.5 sigmas – either because the process mean will move over time, or because the long-term standard deviation of the process will be greater than that observed in the short term, or both.

Hence the widely accepted definition of a six sigma process is one that produces 3.4 defective parts per million opportunities (DPMO). This is based on the fact that a process that is normally distributed will have 3.4 parts per million beyond a point that is 4.5 standard deviations above or below the mean (one-sided capability study). So the 3.4 DPMO of a "Six Sigma" process in fact corresponds to 4.5 sigmas, namely 6 sigmas minus the 1.5 sigma shift introduced to account for long-term variation. This is designed to prevent underestimation of the defect levels likely to be encountered in real-life operation.

Source: en.wikipedia.org/wiki/Six_Sigma

Historical overview (Six Sigma)

Six Sigma was originally developed as a set of practices designed to improve manufacturing processes and eliminate defects, but its application was subsequently extended to other types of business processes as well.In Six Sigma, a defect is defined as anything that could lead to customer dissatisfaction.

The particulars of the methodology were first formulated by Bill Smith at Motorola in 1986. Six Sigma was heavily inspired by six preceding decades of quality improvement methodologies such as quality control, TQM, and Zero Defects, based on the work of pioneers such as Shewhart, Deming, Juran, Ishikawa, Taguchi and others.

Like its predecessors, Six Sigma asserts that –

Continuous efforts to achieve stable and predictable process results (i.e. reduce process variation) are of vital importance to business success.
Manufacturing and business processes have characteristics that can be measured, analyzed, improved and controlled.
Achieving sustained quality improvement requires commitment from the entire organization, particularly from top-level management.
Features that set Six Sigma apart from previous quality improvement initiatives include –

A clear focus on achieving measurable and quantifiable financial returns from any Six Sigma project.
An increased emphasis on strong and passionate management leadership and support.
A special infrastructure of "Champions," "Master Black Belts," "Black Belts," etc. to lead and implement the Six Sigma approach.
A clear commitment to making decisions on the basis of verifiable data, rather than assumptions and guesswork.
The term "Six Sigma" is derived from a field of statistics known as process capability studies. Originally, it referred to the ability of manufacturing processes to produce a very high proportion of output within specification. Processes that operate with "six sigma quality" over the short term are assumed to produce long-term defect levels below 3.4 defects per million opportunities (DPMO). Six Sigma's implicit goal is to improve all processes to that level of quality or better.

Six Sigma is a registered service mark and trademark of Motorola, Inc. Motorola has reported over US$17 billion in savings from Six Sigma as of 2006.

Other early adopters of Six Sigma who achieved well-publicized success include Honeywell (previously known as AlliedSignal) and General Electric, where the method was introduced by Jack Welch. By the late 1990s, about two-thirds of the Fortune 500 organizations had begun Six Sigma initiatives with the aim of reducing costs and improving quality.

In recent years, Six Sigma has sometimes been combined with lean manufacturing to yield a methodology named Lean Six Sigma

Source: en.wikipedia.org/wiki/Six_Sigma

Six Sigma

Six Sigma is a business management strategy, initially implemented by Motorola, that today enjoys widespread application in many sectors of industry.

Six Sigma seeks to improve the quality of process outputs by identifying and removing the causes of defects (errors) and variation in manufacturing and business processes.[1] It uses a set of quality management methods, including statistical methods, and creates a special infrastructure of people within the organization ("Black Belts" etc.) who are experts in these methods.[1] Each Six Sigma project carried out within an organization follows a defined sequence of steps and has quantified financial targets (cost reduction or profit increase)

Source: en.wikipedia.org/wiki/Six_Sigma

OHSAS 18001:2007 - let us understand.

For beginners, OHSAS stands for Occupational Health and Safety Assessment Series. OHSAS 18001 specifications were first issued in the year 1999, to enable organizations to assess themselves against the OH&S risks prevailing in their workplace and get themselves certified. However during the intervening period the ISO 9001 and ISO 14001 standards underwent revisions. The OHSAS specifications were due for revision from that point onwards. Initial meeting of group was held in Oct 2006 and SECOND DRAFT was proposed in Nov 2006. Second meeting was held in China in March 2007 and comments from 40 countries were reviewed. The STANDARD(not the specifications) was issued in July 2007. There have been some key changes in the standard which has come out in July 2007. Changes have been done basically to align the OHSMS (OHSAS 18001:2007) with QMS (ISO 9001:2000) and EMS (ISO 14001:2004). Prime intention is to facilitate organizations to move towards Integrated Management system, should they desire to move in that direction. Key focus areas in the revised standard are: 1. Health. 2. Tolerable risk and acceptable risk. 3. Accident and Incident. 4. Hazard and Risk assessment process. 5. Management of change. 6. Compliance evaluation and OH&S performance. 7. Need for continual improvement. 8. Workplace or ‘Place of work’. Health and well being of employees is one of the two strong focus areas in the OHSAS standard. The establishment of OH&S system comprising of Policy, Planning, Implementation and Operation, Checking and corrective action and Management review is the fundamental step. The definition of Occupational health and safety as per standard OHSAS 18001:2007 “conditions and factors that affect, or could affect, the health and safety of employees or other workers (including temporary workers and contractor personnel), visitors, or any other person in the workplace.” Above definition illustrated in 2007 standard now includes “conditions and factors that could affect the health and safety of employees or other workers”. Emphasis is also on the conditions and factors which are presently not getting focus or raising concerns but they are likely to affect the health and safety in due course . Another, key change depicting strong focus on health is definition of workplace. Place of work has now become workplace. The definition of workplace as given in the standard is “ any physical location in which work related activities are performed under the control of Organization”. The ambit has widened and now includes personnel traveling, in transit, working at premises of the client or customer or at working at home.” This is a landmark change. With changing working environment, economic conditions and our transgression to borderless world, the OH&S management system definitely has widened and covers all the activities in its influence.

Source: qmsforyou.blogspot.com

Internal Auditing Tips

On this page we will be adding tips to assist you in your auditing efforts.

Free Tip #1:
Contact auditees at least four times about their scheduled audit. The first contact would come when the annual audit schedule is generated. The second should be about one month prior to the audit. This allows the auditee time to prepare for any additional resources necessary (They shouldn't need extra time to "get their areas squared away".). The third contact should be about a week before the audit. At this time, you can give the auditee a detailed schedule about exact times, and locations of audit activities. For example, you will be auditing receiving inspection at 10:45. Each of these contacts should be in writing (email is just as good). The day before the audit, place a quick phone call (or voicemail) to verify the audit.

Of course, you still need to have an opening meeting, and that is in addition to the above. The reason for the multiple contacts is simply, we tend to forget things due to our work load. Audits should never be a surprise, this ensures the auditee has every chance to prepare.

Free Tip #2:
When preparing the audit schedule take into account such things as:

:: Available resources
:: Audit Scope
:: Sample Size

The key is not to bite off more than your auditors can chew [Translation: Don't over-commit your resources]. Smaller, but more frequent audits may be better than comprehensive three-day audits. Inadequate resources may indicate lace of Executive Management commitment.

Free Tip #3:
One of the hardest things to do is get a quick turn-around time on corrective actions. Auditors are frequently frustrated by lower and mid-management's foot dragging on responding to audit findings. One way to get faster action is to have executive management place effective corrective action turn-around time in management's performance appraisals. By tying in corrective actions to performance appraisals, bonuses, etc., you virtually force management into timely, effective corrective actions. This could also work with audits completed on time, etc. It also shows lower and mid-management that executive management is committed to the process.

Free Tip #4:
If you company has email…try to set up a paperless audit system where the only thing you would need to "print out" and hand write would by your audit worksheet, which you take withy you to collect your evidence/samples. We have a paperless system here - we are able to email out notification forms and audit summaries without ever printing a sheet. It works EXCELLENTLY! We even File our paperless paperwork electronically for when our third -party auditors come to audit!
Write your procedures in Flowchart style. This helps to make the workflows appear that much clearer for new and veteran auditors alike. By having all of our procedures in flowchart style, we have cut down on our audit time by half and increased audit accuracy tremendously!
Jill Chavanne, Internal Audit Program Manager, Weiss-aug. Co

Free Tip #5:
Auditors are frequently frustrated by lower and mid-management's foot dragging on responding to audit findings. One way to improve the timeliness of audit finding responses is to issue reminder notifications. Our audit finding response due dates are normally two weeks from the issue date of the finding. I typically issue two "Reminder of Approaching due date" notifications, one at 50% of allotted response time and the other at 75%. This method can be modified to fit your particular system, i.e. issuing only one notice for lessor response time allotments. This documentation can be in the form of a manual memorandum/form or the more efficient e-mailed memorandum/form. Issuing reminder notifications demonstrates a monitored system and can also prove useful if elevation of the finding becomes necessary.
David A. Wimer, BAE SYSTEMS

Free Tip #6:
"Be sure to follow-up on corrective actions from previous audits: don't only audit to see the corrective actions have been implemented. Make sure the corrective action corrected the problem that caused the corrective action in the first place."

Betsy Hsiao, Quest Analytical

Editor's note: One theme Internal-Auditor.com has pushed over and over again is the output of audit nonconformances should be effective corrective actions. My good friend Betsy is absolutely correct. This is one area where many internal audit programs are weak. We don't want to upset the auditee when the corrective action is ineffective, so we overlook the situation. Read the observation again, study it, and do it!

Free Tip #7:
In order to have an effective Corrective Action, Nonconformities must have three attributes:

They must be Understandable: If the auditee does not understand the nonconformity, they will not know how to deal with it.
They must be Actionable: If there is no action that can be taken, the Corrective Action cannot be achieved.
They must be Unarguable (that is not a word, but it fits): If an auditee can argue ANY part of a nonconformity, they will argue rather than correct.

Free Tip #8:
Auditing is all about asking questions. As an auditor, you have to make sure you ask the right person, the right question. You also have to make sure YOU understand the question you are about to ask. If you don't understand the question, how can you expect to understand the answer. You must also ask questions in a manner that the auditee will understand them.

Source: www.internal-auditor.com/tips.htm

What is OHSAS 18001?

OHSAS 18000 is an international occupational health and safety management system specification. It comprises two parts, 18001 and 18002 and embraces a number of other publications.
For the record, the following other documents, amongst others, were used in the creation process:

• BS8800:1996 Guide to occupational health and safety management systems
• DNV Standard for Certification of Occupational Health and Safety Management Systems(OHSMS):1997
• Technical Report NPR 5001: 1997 Guide to an occupational health and safety management system
• Draft LRQA SMS 8800 Health & safety management systems assessment criteria
• SGS & ISMOL ISA 2000:1997 Requirements for Safety and Health Management Systems
• BVQI SafetyCert: Occupational Safety and Health Management Standard
• Draft AS/NZ 4801 Occupational health and safety management systems Specification with guidance for use
• Draft BSI PAS 088 Occupational health and safety management systems
• UNE 81900 series of pre-standards on the Prevention of occupational risks

Draft NSAI SR 320 Recommendation for an Occupational Health and Safety (OH and S) Management System

OHSAS 18001 is an Occupation Health and Safety Assessment Series for health and safety management systems. It is intended to help an organizations to control occupational health and safety risks. It was devloped in response to widespread demand for a recognized standard against which to be certified and assessed.

Source: http://www.ohsas-18001-occupational-health-and-safety.com

Optimizing Six Sigma at the Top of the World

Here’s a story that proves once again that exciting quality applications can occur anywhere in the world.

BHP Billiton operates the EKATI Diamond Mine in Canada’s Northwest Territo­ries, approximately 200 miles northeast of Yellowknife—just below the Arctic Circle. Arctic winter gear designed for temperature well below -45°C is standard attire during the long winters, when the sun barely rises above the horizon. Although the setting is harsh, it can also be a beautiful place to observe and enjoy a truly unique perspective on nature.

EKATI is proud of its commitment to become the safest, lowest-cost pro­ducer of quality diamonds in the world. Employees at EKATI are passionate about creating a safe and sustainable business and thriving communities, as well as developing people. This business strives to select, develop, and retain the right people while extracting value from low-value ores. The business drivers are to create zero harm, increase margin per ton, and create an engaged workforce.

In 2007, a new management team at the EKATI mine kicked off a lean Six Sigma deployment that utilized a five-year plan to drive breakthrough improvements. How­ever, as for so many organizations, EKATI was also challenged with accurately and easily tracking and archiving improvement programs. Keeping tabs on and archiving the mine’s various quality improvement initiatives using spreadsheets was a time-consuming challenge—thus the need for an enterprisewide software tracking system.

In an environment in which saving just a few dollars per ton of mined diamonds is considered a major success, there is a profound need for extremely accurate tracking of the financial benefits of proj­ects. Tracking and validating bottom-line value in the current recession is critical and allows for control and the ability to maneuver with a lean Six Sigma work­force.

“You always need tracking for what’s in existence and what isn’t,” says Aart Broekhuizen, business excellence manager at BHP Billiton’s EKATI mine. “You need to see the different phases of projects, and you want to have some understanding of the past performance of projects in case it’s needed for future reference, as well as being able to track and sustain the bottom line and continuously enhance business processes and systems.”

With this stated objective in mind, and after a diligent search of avail­able options, Broekhuizen and the rest of the mine’s quality excellence team decided to entrust the tracking soft­ware portion of their Six Sigma pro­gram to EnterpriseTrack from Instantis Inc. of Santa Clara, California. Instantis is an on-demand provider of project management solutions, and EnterpriseTrack is a full-featured, web-based solu­tion that allows companies to initiate, track, and manage Six Sigma and other performance initiatives across the entire organization.

Adaptability is one of the key fea­tures of EnterpriseTrack. “The degree of configurability was a key issue,” says Howard Pujol, strategic engagement manager at Instantis. “BHP Billiton EKATI management knew what they wanted, and were very clear on the functionality that they desired.”

For example, mine management quickly discovered that the software helped tie together often disparate elements of the organization into a unified whole. “We designed how best to use the software in meetings with our management team, Master Black Belts, and Black Belts,” says Broekhuizen. “The whole thing is a process of engagement and enrol­ment—the belts and their teams will work on projects, and the software also brings in the finance department to track and validate monetary value.”

EnterpriseTrack has proven handy for document tracking, and users have the ability to sort and find a single project, instantly uncover the status of that project, look at the timeline, and ana­lyze metrics and benchmarks. The user can standardize exactly how he or she wishes to track and handle the granular information uncovered in the “Analyze” phase of a Six Sigma implementation. Ten fully integrated modules, including Strategy Manager, Process Manager, Idea Manager, Proposal Manager, Projects Manager, Knowledge Manager, Metrics Manager, and VOC Manager, all of which plug into EnterpriseTrack’s world-class dashboards and reports, offer a complete view into the deployment, from top to bottom.

Benefits:

• Web-based solution that initiates, tracks, and manages Six Sigma and other per­formance initiatives for organizations in a wide variety of industries.
• Highly flexible and adaptable
• Collects inputs from various sectors of the organization and makes it easy to track status of projects.

Source: qualitydigest.com/inside

Abstract ISO 14001:2004

ISO 14001:2004 specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and other requirements to which the organization subscribes, and information about significant environmental aspects. It applies to those environmental aspects that the organization identifies as those which it can control and those which it can influence. It does not itself state specific environmental performance criteria.

ISO 14001:2004 is applicable to any organization that wishes to establish, implement, maintain and improve an environmental management system, to assure itself of conformity with its stated environmental policy, and to demonstrate conformity with ISO 14001:2004 by

a) making a self-determination and self-declaration, or

b) seeking confirmation of its conformance by parties having an interest in the organization, such as customers, or

c) seeking confirmation of its self-declaration by a party external to the organization, or

d) seeking certification/registration of its environmental management system by an external organization.

All the requirements in ISO 14001:2004 are intended to be incorporated into any environmental management system. The extent of the application will depend on factors such as the environmental policy of the organization, the nature of its activities, products and services and the location where and the conditions in which it functions.

ISO 14001:2004 also provides, in Annex A, informative guidance on its use

Source: iso.org/iso

ISO 14000 Essentials

The ISO 14000 family addresses various aspects of environmental management. The very first two standards, ISO 14001:2004 and ISO 14004:2004 deal with environmental management systems (EMS). ISO 14001:2004 provides the requirements for an EMS and ISO 14004:2004 gives general EMS guidelines.

The other standards and guidelines in the family address specific environmental aspects, including: labeling, performance evaluation, life cycle analysis, communication and auditing.

An ISO 14001:2004-based EMS

An EMS meeting the requirements of ISO 14001:2004 is a management tool enabling an organization of any size or type to:

• identify and control the environmental impact of its activities, products or services, and to
• improve its environmental performance continually, and to
• implement a systematic approach to setting environmental objectives and targets, to achieving these and to demonstrating that they have been achieved

How it works

ISO 14001:2004 does not specify levels of environmental performance. If it specified levels of environmental performance, they would have to be specific to each business activity and this would require a specific EMS standard for each business. That is not the intention.

ISO has many other standards dealing with specific environmental issues. The intention of ISO 14001:2004 is to provide a framework for a holistic, strategic approach to the organization's environmental policy, plans and actions.

ISO 14001:2004 gives the generic requirements for an environmental management system. The underlying philosophy is that whatever the organization's activity, the requirements of an effective EMS are the same.

This has the effect of establishing a common reference for communicating about environmental management issues between organizations and their customers, regulators, the public and other stakeholders.

Because ISO 14001:2004 does not lay down levels of environmental performance, the standard can to be implemented by a wide variety of organizations, whatever their current level of environmental maturity. However, a commitment to compliance with applicable environmental legislation and regulations is required, along with a commitment to continual improvement – for which the EMS provides the framework.

The EMS standards

ISO 14004:2004 provides guidelines on the elements of an environmental management system and its implementation, and discusses principal issues involved.

ISO 14001:2004 specifies the requirements for such an environmental management system. Fulfilling these requirements demands objective evidence which can be audited to demonstrate that the environmental management system is operating effectively in conformity to the standard.

What can be achieved

ISO 14001:2004 is a tool that can be used to meet internal objectives:

• provide assurance to management that it is in control of the organizational processes and activities having an impact on the environment
• assure employees that they are working for an environmentally responsible organization.

ISO 14001:2004 can also be used to meet external objectives:

• provide assurance on environmental issues to external stakeholders – such as customers, the community and regulatory agencies
• comply with environmental regulations
• support the organization's claims and communication about its own environmental policies, plans and actions
• provides a framework for demonstrating conformity via suppliers' declarations of conformity, assessment of conformity by an external stakeholder - such as a business client - and for certification of conformity by an independent certification body.

Source: iso.org/iso/iso_catalogue/management_standards

ISO 9000 Essentials

The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines relating to quality management systems and related supporting standards.

ISO 9001:2008 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.

The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects.

Why an organization should implement ISO 9001:2008
Without satisfied customers, an organization is in peril! To keep customers satisfied, the organization needs to meet their requirements. The ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing the organization's processes so that they consistently turn out product that satisfies customers' expectations.

How the ISO 9001:2008 model works
The requirements for a quality system have been standardized - but many organizations like to think of themselves as unique. So how does ISO 9001:2008 allow for the diversity of say, on the one hand, a "Mr. and Mrs." enterprise, and on the other, to a multinational manufacturing company with service components, or a public utility, or a government administration?

The answer is that ISO 9001:2008 lays down what requirements your quality system must meet, but does not dictate how they should be met in any particular organization. This leaves great scope and flexibility for implementation in different business sectors and business cultures, as well as in different national cultures.

Checking that it works

• The standard requires the organization itself to audit its ISO 9001:2008-based quality system to verify that it is managing its processes effectively - or, to put it another way, to check that it is fully in control of its activities.
• In addition, the organization may invite its clients to audit the quality system in order to give them confidence that the organization is capable of delivering products or services that will meet their requirements.
• Lastly, the organization may engage the services of an independent quality system certification body to obtain an ISO 9001:2008 certificate of conformity. This last option has proved extremely popular in the market-place because of the perceived credibility of an independent assessment.

The organization may thus avoid multiple audits by its clients, or reduce the frequency or duration of client audits. The certificate can also serve as a business reference between the organization and potential clients, especially when supplier and client are new to each other, or far removed geographically, as in an export context.

Source: iso.org/iso/iso_catalogue/management_standards

Abstract ISO 9001:2008

ISO 9001:2008 specifies requirements for a quality management system where an organization.

• needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
• aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

Source : iso.org

Should Quality Have Time Limits?

Where’s my coffee and a hot shower!

Anyone who has ever purchased merchandise from L.L. Bean is no doubt aware of this rock solid guarantee:
“Our products are guaranteed to give 100% satisfaction in every way. Return anything purchased from us at any time if it proves otherwise. We do not want you to have anything from L.L. Bean that is not completely satisfactory.... Of course, we want you to be the fair judge of quality. If you’re not satisfied with your purchase, we’ll replace it or give you your money back. It’s that simple”.

In my mind, this is the gold standard for how customers should be treated. I’m an L.L. Bean fan and have jackets, coats, fanny packs, and other outerwear that has never worn out. It should come as no surprise that L.L. Bean was just honored as being No. 1 in customer service by the National Retail Federation’s American Express Customers’ Choice survey. What is remarkable about L.L. Bean is that only rarely does one have to activate this guarantee, because merchandise from the company is first-class. If only other companies would adhere to this strong quality ethic. Let me give you an example of how some companies administer their own guarantees.


source : www.qualitydigest.com

What is ISO 9000 and Should I Care?

The ISO 9000 series of standards

ISO 9000 consists of a series of Quality Management System standards that are designed to facilitate the establishment of business processes aiming to ensure that customer requirements are met or exceeded. They can be applied in any manufacturing industry or service sector.

Why should an organization implement ISO 9001?
Without satisfied customers, an organization's future is at risk! To keep customers satisfied, the organization needs to meet and/or exceed their requirements. The ISO 9001 standard provides a universally recognized, tried and tested framework for taking a systematic approach to managing the organization's processes, so that they consistently turn out product that satisfies customers' expectations.

The 5 main clauses of ISO 9001:2008

* Quality Management System
* Management Responsibility
* Resource Management
* Product Realization
* Measurement, Analysis and Improvement

Industry specific variations of ISO 9000

A number of different industry sectors have adopted ISO 9001, added supplemental requirements which are specific to their own industry, and modified the title of the standard. The most notable of these are:

* ISO/TS 16949 - Automotive
* AS9100, 9110 and 9120 - Aerospace
* ISO 13485 - Medical Devices
* TL 9000 - Telecommunications

Application of the standards

The standards are not designed to tell you how to run your business, but rather to allow you to be compliant with the standard in a manner that best suits the way you decide to run your business. There are some “shalls” which are non-negotiable requirements if you wish to be certified by an independent certification body, also known as registrars.


source : www.qualitydigest.com

Four Essentials of Effective Work Instructions

Returning the focus to the worker

A work instruction is a tool provided to help someone do a job correctly. This simple statement implies that the purpose of the work instruction is quality and that the target user is the worker. Unfortunately, in many workplaces, today’s work instructions have little connection with this fundamental focus. Factories have encumbered work instructions with content that has been added to satisfy auditors, lawyers, engineers, accountants, and yes, even quality managers. We’ve piled on so much extraneous material that we’ve lost sight of the intended purpose of work instructions.

Instead of providing a simple tool to do a job right, we’ve buried the work instruction under a cascade of specifications, contract requirements, revision history, references, controls, licensing provisions, and engineering theory. The person who uses the work instruction has become an afterthought in favor of satisfying a licensing or certifying auditor.


Source : http://qmsforyou.blogspot.com/

EnterpriseIQ - EnterpriseIQ Quality Management System

he Quality Management System within EnterpriseIQ provides a systematic approach to meeting all your quality needs. It provides the tools and capabilities necessary to ensure customer satisfaction and compliance with the most stringent quality standards, including automotive (QS and TS), medical (21 CFR Part 11) and ISO standards. Electronic signatures, automatic Workflow, CAPA/CAR, APQP/PQ, SPC and Cost of Quality are all aspects of this package, written and designed by IQMS and tied directly into your complete ERP system - eliminating redundant data and increasing efficiency.

QMS is a truly embedded Quality Management System that was designed and written by IQMS, therefore, it ties directly into your complete ERP system. The result – increased efficiency and eliminating redundant data entry thus, saving time, reducing costly errors and improving communication.

The EnterpriseIQ Quality Management System is a comprehensive suite of applications including key features and functionality such as:

Advanced Product Quality Planning (APQP/PQ)
With QMS you can ensure that you are complying with ISO and FDA requirements through completely tracking of all the information required for process documentation and definition.

Corrective Action Request (CAR/CAPA)
Define, schedule, manage, assign and track Corrective Action Requests (CARs) in order to ensure compliance and meet supplier/customer requirements. This application helps you drive tighter cost control and avoid losing money due to your products or services being completed incorrectly the first time.

Device History Record (DHR) and Product Lifecycle Management (PLM)
This module gives you the ability to follow the product from the design and quoting process to the production stage and all the way through to the end of the life of the product. You will benefit from the open communication this application provides with your suppliers and customers through the use of web-based workflow tools and email.

Document Control
The Secure Document Control application helps you keep full control over your documents. It tracks the document from creation, through approval, implementation and obsolescence. Through electronic signatures and approvals, you will increase visibility of the record and enhance your reaction time all while keeping in line with the strictest quality requirements including automotive, ISO and medical standards.

Some additional functions of EnterpriseIQ QMS include:

• Material Review Board (MRB) module
  
• Repeatability and Reproducibility (R&R) Calibration module
  
• Statistical Process Control (SPC) modulde
  
• Engineering Change Order System module

Sourec : http://www.2020software.com

ISO 9001:2000 - Your Management Review

Just as every organization undertakes an annual ritual of financial review, forecasting, planning and budgeting, a similar approach is specified in the ISO 9001:2000 standard for quality management. In the ISO 9001 standard, this process is referred to as a Management Review. Typically, such reviews are held as regularly scheduled events within an organization, with top management convening to review the performance of its quality management system against organizational goals and objectives, and other criteria as specified within the standard.

Specifically, as stated within the ISO 9001 standard, the purpose of a management review is to review the Quality Management System to ensure its continuing adequacy, suitability and effectiveness. This should include an evaluation of the performance of the system based on existing data (review inputs), and should also address any decisions or actions necessary to improve the program and its related processes (review outputs).

To further define the concepts of adequacy, suitability and effectiveness:

1. Adequacy – Sufficient to satisfy a requirement or meet a need*. A quality management system should be capable of satisfying applicable requirements including those specified by the organization, the customer, and any applicable standards and/or regulations.

2. Suitability – The quality of having properties that are right for the specific purpose*. A quality management system should be able to sustain the current performance levels of the organization utilizing an acceptable amount of organizational resources.

3. Effectiveness – Adequate to accomplish a purpose; producing the intended or expected result*. A quality management system should enable the organization to meet its own needs, those of the customer and those of other interested parties.

*Random House Unabridged Dictionary, © Random House, Inc. 2006.

As a minimum, such reviews should be performed annually, although they may be performed on a more frequent basis, including quarterly or even monthly. I personally recommend that oganizations with “newer” systems perform this function on a more frequent basis, at least for the first 18-24 months.

Records of these reviews should be maintained in accordance with documented record control procedures. These records should include, as a minimum, the date of the review, participants in the review, criteria by which the system is measured, strengths and weaknesses of the system, and any decisions or actions that are required.

To assist the organization that is new to this process, I’ve attached the following management review template below. These topics should be considered as the “bare minimum” necessary, and this template should be further modified or expanded, as necessary, to address any additional issues or considerations that the organization may have.

Source : http://masquality.com