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