This is a forum where I shall share my experience and understanding on Corporate Social Responsibility, Sustainability and Organisational Performance Improvement issues. Viewers - Please feel free to discuss and ask questions.
Sunday, August 30, 2009
Quality Management System Documentation
In my opinion, the QMS documentation of a Quality Management System must address two major issues:
· Shall be in line with the size of the organisation and complexity of the processes
· The need for the amount and detail of documentation required must be more relevant to the desired results of the organization’s process activities.
Organizations (and in particular small organizations) may be able to demonstrate conformity without the need for extensive documentation
Management should define the documentation needed to implement, maintain, and improve the quality management system. This documentation may include:
· Policy documents (including the quality manual)
· Process Mapping - Documentation for the control of processes
· Work instructions for specific job tasks
· Standard formats for data collection and reporting
Level 1: ISO 9001 Quality Manual
The quality manual, sometimes referred to as the policy manual, typically includes:
• Organization Quality policy and Objectives • Any exclusions of ISO 9001 requirements and related justification• Overview of the organization and its functions (processes)• Overview of its products, services, and sites• Sequence and interaction of the processes• Management responsibility for policies and processes• Inclusion or references to the next documentation level (procedures)
The quality manual is useful to:• Customers - provides assurance• External auditors - facilitates the audit• Employees - useful as a training aid
The quality manual must be approved by management and placed under document control. Generally it is structured in the order of the ISO 9001 clauses.
Level 2: ISO 9001 Quality System Procedures
· Describes the who, what, when, and where of the quality system processes
· Describes the inter-departmental controls that address the ISO 9001 requirements
· Should include six mandatory procedures as required by ISO 9001:2008
· May be in ISO 9001 order or any order practical to the company
· Should describe the process flow, linkages, combination and interaction among departments
· Should reference the lower level documentation (operational documentation)
· Should involve participation of department personnel in writing them
· Must be available, known, and used by pertinent personnel
· Must be kept up to date and changes controlled
Level 3: Operational documentation (Also known as Work Instruction / OCP - Operation Control Procedure / Protocols / Methods)
· Explains details of specific tasks or activities – the how of performing a specific task, making or verifying process and product activities
· Includes documents such as quality plans, forms, drawings, flowcharts, workmanship standards, work instructions, product or service specifications, machine manuals, visual displays, computer templates, photographs, and illustrations
· Need for documentation may be based on the complexity of products or processes, skills, training, education, stability of the work force, past problems, customer and regulatory requirements, industry standards, and requirements
· Must be available, known, and used by pertinent personnel
· Must be kept up to date and changes controlled
Level 4: Records
· Provide objective evidence that quality activities were carried out and results achieved in accordance with levels 1, 2, and 3 documentation
· May be mandatory or implied for each ISO 9001 clause
· May have records beyond ISO 9001 requirements (if organisation or customers require so)
· Examples are records of inspection, calibration, management review, training, audit reports, design review, purchasing, and nonconforming product reports
Thursday, August 27, 2009
Introduction to ISO
The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from some 168 countries, one from each country.
ISO is a non-governmental organization established in 1947. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity.
ISO's work results in international agreements which are published as International Standards.
Many people will have noticed a seeming lack of correspondence between the official title when used in full, International Organization for Standardization, and the short form, ISO. Shouldn't the acronym be "IOS"? Yes, if it were an acronym – which it is not.
In fact, "ISO" is a word, derived from the Greek “isos”, meaning "equal", which is the root of the prefix "iso-" that occurs in a host of terms, such as "isometric" (of equal measure or dimensions) and "isonomy" (equality of laws, or of people before the law).
From "equal" to "standard", the line of thinking that led to the choice of "ISO" as the name of the organization is easy to follow. Whatever the country, the short form of the Organization's name is always ISO.
Why is international standardization needed?
The existence of non-harmonized standards for similar technologies in different countries or regions can contribute to so-called "technical barriers to trade". Export-minded industries have long sensed the need to agree on world standards to help rationalize the international trading process. This was the origin of the establishment of ISO.
International standardization is well-established for many technologies in such diverse fields as information processing and communications, textiles, packaging, distribution of goods, energy production and utilization, shipbuilding, banking and financial services. It will continue to grow in importance for all sectors of industrial activity for the foreseeable future.
Industry-wide standardization is a condition existing within a particular industrial sector when the large majority of products or services conform to the same standards. It results from consensus agreements reached between all economic players in that industrial sector - suppliers, users, and often governments. They agree on specifications and criteria to be applied consistently in the choice and classification of materials, the manufacture of products, and the provision of services. The aim is to facilitate trade, exchange and technology transfer through:
· enhanced product quality and reliability at a reasonable price;
· improved health, safety and environmental protection, and reduction of waste;
· greater compatibility and interoperability of goods and services;
· simplification for improved usability;
· reduction in the number of models, and thus reduction in costs;
· increased distribution efficiency, and ease of maintenance.
Users have more confidence in products and services that conform to International Standards. Assurance of conformity can be provided by manufacturers' declarations, or by audits carried out by independent bodies.
ISO's achievements
Below are some examples of ISO standards that have been widely adopted, giving clear benefits to industry, trade and consumers.
· The ISO film speed code, among many other photographic equipment standards, has been adopted worldwide making things simpler for the general user.
· Standardization of the format of telephone and banking cards means the cards can be used worldwide.
· Tens of thousands of businesses are implementing ISO 9000 which provides a framework for quality management and quality assurance. The ISO 14000 series provides a similar framework for environmental management.
· The internationally standardized freight container enables all components of a transport system - air and seaport facilities, railways, highways, and packages - to interface efficiently. This, combined with standardized documents to identify sensitive or dangerous cargoes makes international trade cheaper, faster and safer.
· m, kg, s, A, K, mol, cd are the symbols representing the seven base units of the universal system of measurement known as SI (Système international d'unités). The SI system is covered by a series of 14 International Standards. Without these standards shopping and trade would be haphazard and technological development would be handicapped.
· Paper sizes. The original standard was published by DIN in 1922. Now used worldwide as ISO 216, standard paper sizes allow economies of scale with cost benefits to both producers and consumers.
· A well-designed symbol conveys a clearcut message in a multilingual world. The same symbols for automobile controls are displayed in cars all over the world, no matter where they are manufactured.
· The ISO international codes for country names, currencies and languages help to eliminate duplication and incompatibilities in the collection, processing and dissemination of information. As resource-saving tools, universally understandable codes play an important role in both automated and manual documentation.
· The diversity of screw threads for identical applications used to represent an important technical obstacle to trade. It caused maintenance problems, and lost or damaged nuts or bolts could not easily be replaced. A global solution is supplied in the ISO standards for ISO metric screw threads.
Who makes up ISO?
ISO is made up of its members which are divided into three categories:
A member body of ISO is the national body "most representative of standardization in its country". Thus, only one body in each country may be admitted to membership of ISO.
Member bodies are entitled to participate and exercise full voting rights on any technical committee and policy committee of ISO.
Who does the work?
The technical work of ISO is highly decentralized, carried out in a hierarchy of some 2 850 technical committees, subcommittees and working groups. In these committees, qualified representatives of industry, research institutes, government authorities, consumer bodies, and international organizations from all over the world come together as equal partners in the resolution of global standardization problems. Some 30 000 experts participate in meetings each year.
What fields are covered?
The scope of ISO is not limited to any particular branch; it covers all technical fields except electrical and electronic engineering, which is the responsibility of IEC. The work in the field of information technology is carried out by a joint ISO/IEC technical committee (JTC 1).
How are ISO standards developed?
ISO standards are developed according to the following principles:
· ConsensusThe views of all interests are taken into account: manufacturers, vendors and users, consumer groups, testing laboratories, governments, engineering professions and research organizations.
· Industry-wideGlobal solutions to satisfy industries and customers worldwide.
· VoluntaryInternational standardization is market-driven and therefore based on voluntary involvement of all interests in the market-place.
There are three main phases in the ISO standards development process.
The need for a standard is usually expressed by an industry sector, which communicates this need to a national member body. The latter proposes the new work item to ISO as a whole. Once the need for an International Standard has been recognized and formally agreed, the first phase involves definition of the technical scope of the future standard. This phase is usually carried out in working groups which comprise technical experts from countries interested in the subject matter.
Once agreement has been reached on which technical aspects are to be covered in the standard, a second phase is entered during which countries negotiate the detailed specifications within the standard. This is the consensus-building phase.
The final phase comprises the formal approval of the resulting draft International Standard (the acceptance criteria stipulate approval by two-thirds of the ISO members that have participated actively in the standards development process, and approval by 75 % of all members that vote), following which the agreed text is published as an ISO International Standard.
Most standards require periodic revision. Several factors combine to render a standard out of date: technological evolution, new methods and materials, new quality and safety requirements. To take account of these factors, ISO has established the general rule that all ISO standards should be reviewed at intervals of not more than five years. On occasion, it is necessary to revise a standard earlier.
How is ISO's work financed?
The financing of ISO closely reflects its decentralized mode of operation with, on the one hand, the financing of the Central Secretariat activities and, on the other hand, the financing of the technical work as such.
The financing of the Central Secretariat derives from member subscriptions (80 %) and revenues from the sale of the Organization's standards and other publications (20 %).
How it all started
International standardization began in the electrotechnical field: the International Electrotechnical Commission (IEC) was created in 1906. Pioneering work in other fields was carried out by the International Federation of the National Standardizing Associations (ISA), which was set up in 1926. The emphasis within ISA was laid heavily on mechanical engineering.
ISA's activities ceased in 1942, owing to the Second World War. Following a meeting in London in 1946, delegates from 25 countries decided to create a new international organization "the object of which would be to facilitate the international coordination and unification of industrial standards". The new organization, ISO, began to function officially on 23 February 1947.
The first ISO standard was published in 1951 with the title, "Standard reference temperature for industrial length measurement".
Extract from www.iso.org
Monday, August 24, 2009
ISO Best Practices
To achieve compliance with ISO guidelines, the following best practices should form the basis of all ISO programs:
Establish clearly defined business processes.
The first step in ISO compliance is to clearly define business processes that are essential to quality control. Once these processes are identified and documented, steps can be taken to optimize processes for maximum efficiency.
Conduct detailed internal audits and identify gaps.
An internal audit of all quality and business processes is a good first step towards ISO compliance. The audit will reveal quality gaps and identify process inefficiencies. Once this proactive step is taken, it is important to take corrective action to ensure that all audit issues are addressed in a timely manner.
Conduct quality audits.
Internal audits are a mandatory aspect of ISO compliance. However, organizations interested in becoming a best-in-class company should consider additional external audits to serve as an independent validation and verification of your processeses and look for improvement opportunities.
Establish effective closed-loop corrective and preventive action processes
Once processes are established, an effective closed-loop corrective and preventive action process should be implemented for optimal results. The closed-loop nature of the process ensures that all issues will be addressed and closed as is appropriate.
Define and publish quality control procedures.
Quality standards mandate written quality control procedures. These procedures should be written, approved, and distributed throughout the organization to ensure compliance.
Define quality monitoring processes.
No ISO process is complete without an effective way of monitoring processes. Monitoring is an essential requirement for ISO because it ensures that guidelines are consistently being followed.
Establish continuous improvement guidelines and procedures
The monitoring process will reveal the need for continuous improvement of the product or process governed. Continuous improvement guidelines should be established to ensure that these issues are addressed in the most appropriate manner. These guidelines should be published and distributed to ensure consistency and completeness.
Establish and maintain an effective training program.
ISO compliance also mandates that all affected persons within an organization receive proper training. This is essential to quality assurance and risk mitigation. It is current best practice to automate the training and tracking process to ensure compliance with stated training requirements. Most organizations use training tracking technology to address these requirements.
Implement quality process automation.
As organizations mature in their approach towards ISO compliance, they are seeking to automate ISO-related processes. More importantly, they seek to do this without expensive software customization and professional services.
Drive quality from the top down.
Quality impacts every aspect of business and ultimately affects the client or end user. Thus, it is current best practice to drive ISO initiatives from the very top of the organization to ensure adequate resource allocation where appropriate and enforcement of ISO policies.
Sunday, August 23, 2009
Waste to Wealth
Wealth from Waste is not a new concept to the companies worldwide. Benefits from waste can be divided into two parts –
1) Waste Minimization program which improves the financial bottom line of the company i.e. reduces cost of operation.
2) Revenue generation models which help the organisation to generate Short Term / Long Term or Continuous income which improves the Financial top line of the organisation.
Challenges:
To convert Linear Flow (Generation – Collection – Transportation – Disposal) to Cyclic Flow
Lack of Attitude
Lack of Structured Approach
Lack of awareness
Drivers:
- Management Commitment
- Waste Management Policy and Objectives
- Building a Waste Management team within the organisation Awareness Encouragement & appreciation to all organisational members including vendors
-
Waste Minimization Programs
Prevention (Reduce)
Waste management starts with the concept of terminate the source of waste generation. The cornerstone of waste management is prevention which means using less material to do the same job, cutting waste before recycling.
Regardless of industry sector, everyone can take advantage of general waste prevention goals, such as double-sided copying, packaging reduction, or switching to reusable supplies.
Some companies go beyond the basics and implemented activities that target industry specific waste materials.
- Reduction in quantity of packaging materials
Buying or Manufacturing Recycled Products (Reuse)
Many companies commit to increasing the overall recycled content in the products they purchase. Manufacturers can either increase the percentage of post consumer content in the products they make or increase the recycled content in the products they purchase.
Buy-recycled activities of companies include:
- Use plastic shipping crates, trays, and bins with recycled content.
- Use recycled-content paperboard packaging.
Recycling Collection (Recycle)
Companies commit to initiating, expanding, or improving company programs to collect recyclables
Recycling Collection activities of companies include:
- Beverage Industry: Collection of pet bottles
- Automobile Industry: Use universal recycling code markings on plastic automobile parts for future dismantling and recycling.
- Compost agricultural byproducts.
Many people think of the concept of Reduce, Re-use, and Recycle as three equal options, but they are instead meant to be a hierarchy, in order of importance.
This distinction is lost on many people. They focus on recycling, but recycling is meant to be the last of those three options. Recycling only comes into the equation when you have something you must dispose of.
If you don’t generate the waste in the first place, then you don’t have to figure out how to deal with it. Many people forget that if you reduce the amount of waste you produce, or re-use it, then you will have also less material to throw out or recycle.
Revenue Framework:
There many revenue models available and being used by several industries successfully. Here, we are discussing two very successful and reasonably moderate technology models:
Biogas (High Methane Content) recovery from waste water systems and utilization for energy generation
Sources of Biogas: Distillery Waste, Municipal Solid Waste, Poultry Litter, Cow Dung, Vegetable Waste
Biomass (agricultural waste) Gasification of and utilization in Energy (Thermal / Electrical) generation
Sources of Biomass: wood chips, rice husk, Saw Dust
Technology:
1) Gas can be directly fired in engines (100% gas based or dual fuel)
2) May be fired directly for thermal application like drying, heat treatment etc.
3) Fired in boilers for steam generations and further used in process
Revenue Sources:
Changing of fossil fuel to renewable biomass – This gives a considerable ( 50 – 60%) reduction in the power cost.
Central Financial Assistance (CFA) for projects of different categories would be given in the form of Capital Subsidy to the promoters Ministry of New & Renewable Energy to the promoters as given below:
Sl. Waste / Processes / Technologies Capital Subsidy
1. Industrial waste to Bio Gas
i) Biomethanation of low energy density and difficult industrial wastes (i.e. dairy, Tannery, sugar(liquid), slaughterhouse, bagasse wash, textile(liquid), paper(liquid) and pharmaceutical industry)
Rs. 1.0 Crore / MWeq (12000 Cu.m biogas per day)
ii) Biomethanation of other industrial waste
Rs. 0.50 Crore / MWeq (12000 Cu.m biogas per day)
2. Power generation from Biogas
i) Boiler + Steam Turbine configuration
Rs. 0.20 Crore / MW
ii) Biogas engine / Turbine configuration
Rs. 1.00 Crore / MW
3. Power generation from solid industrial waste (Boiler + Steam Turbine Configuration)
Rs. 0.20 Crore / MW
CDM (Clean Development Mechanism) Benefit
All these projects when get qualified for Carbon Credit after approval of UNFCCC. That will bring in the opportunity to earn considerable revenue for a period of 10 or 21 years.
For example,
In case of power generation from renewable sources, 3.4 Crores / MW in a period of 10 years is the earning potential considering 10 Euro (Aug 2009 average rate) / Ton of CO2 emission equivalent reduction.