System Certifications

ISO 9001: 2008 is the fourth edition of ISO 9001 quality management system. It does not contain any new requirements and simply elaborates the existing system by fine tuning the clauses of ISO 9001: 2000. The introduced changes simply intend to make ISO 9001:2008 compatible with ISO 14001:2004 standard (environmental management systems).

The requirements of ISO 9001:2008 are intended for all organizations, regardless of type or size. This system would replace the existing one providing a framework to the organizations for controlling processes in order to achieve customer satisfaction, regulatory compliance and continual improvement.

ISO 9001:2008 specifies requirements for a quality management system where an organization has to demonstrate its ability to consistently deliver product that meet customer's requirement and the applicable statutory & regulatory guidelines. ISO 9001:2008 aims to enhance customer satisfaction through the effective application of the system.

ISO 13485 represents the requirements for a comprehensive management system for the design and manufacturing of medical devices. While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. More over, compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements.

However, the fundamental difference between the two is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires the organization to demonstrate that the quality system is implemented and maintained.

ISO 14001 is an internationally recognized standard, which specifies requirements for an environmental management system. The standard enables an organization to formulate policy and objectives, taking into account legislative requirements and information about significant environmental impacts.

ISO 14000 applies to environmental aspects, upon which the organization has control over and is expected to have an influence. It does not itself state specific environmental performance criteria.

ISO/TS 16949 QMS defines the quality management system for the design, development, production (and wherever applicable), installation and service of automotive related products. The main aim of the system is to have continual improvement, emphasizing defect prevention and reduction of variation and waste in the supply chain.

ISO/TS 16949 QMS technical specification is applicable to sites of the organization where customer specified parts, for production and/or service, are manufactured. It differs from other ISO standards in two important ways: It is restricted to automotive companies and their suppliers; and it requires compliance with customer's requirements worldwide and not just regionally.

ISO 17025 is the Management system that refers to the organization's structure for managing its processes or activities that transforms inputs of resources into a product or service. The organization's objectives can be classified as satisfying the customer's quality requirements, complying with regulations or meeting environmental objectives.

ISO 17025 incorporates all the ISO 9001 requirements that are relevant to the scope of testing and calibration services as well as specifying the technical requirements for technical competence.

ISO 22000: 2005 is an internationally recognized standard specifically developed for the Food Industry. The standard aims to harmonize the requirements for food safety management throughout the food supply chain.

ISO 22000 is the only internationally recognized standard for the food industry, covering all organizations in the food chain from farmers to catering and defines the requirements of a food safety management system.

Hazard Analysis and Critical Control Point or HACCP is a Systematic Quality Method for Food, Dairy Products and Beverage Industry including services to detect and control the possible Chemical, Physical and Biological hazards within a process.

It involves the following elements :

• Analyze hazards
• Identify critical control points
• Establish preventive measures with critical limits for each control point
• Establish procedures to monitor the critical control points
• Establish corrective actions to be taken when monitoring shows that a critical limit has not been met
• Establish corrective actions to be taken when monitoring shows that a critical limit has not been met
• Establish effective record keeping to document the HACCP system

ISO 27001 concerns international best practices that organizations follow for the secured management of information. It specifies measures, what effects they have and how to implement them.

The standard defines the desired best practice methods for controlling (Protecting) information - Confidentiality, Integrity & Availability and it requires to be audited and registered by a third party Certification Body.

In today's IT driven world, organizations are seeking to demonstrate to their stakeholders, business partners and customers, some form of 'fit for purpose' assurance regarding their information security.

OHSAS 18000 is intended to help an organization to control occupational health and safety risks. It was developed in response to widespread demand for a recognized standard against which the company needs to be certified and assessed.

OHSAS, essentially helps organizations in a number of ways like it helps in minimizing risk to employees, improve existing OH&S management system, demonstrate diligence, gain assurance besides a number of other benefits.

SA 8000 is an International Standard for Social Accountability and is developed by Social Accountability International (SAI). The objective of SA 8000 is to ensure ethical sourcing of goods and services. SA 8000 is a voluntary standard and can be applied to any size of organization or business across all industries.

SA 8000 is used around the world to assure just and decent working conditions by protecting widely accepted labor rights. SA 8000 sets basic standard for :

• Child Labour
• Forced Labour
• Health and Safety
• Freedom of association and the right to collective bargaining
• Discrimination
• Working Hours
• Compensation

Capability Maturity Model Integration (CMMI) is a process improvement system that provides organizations with the essential elements of achieving effective processes. It can be used to guide process improvement across a project, a division or an entire organization.

CMMI helps integrate traditionally separate organizational functions, set process improvement goals and priorities, provide guidance for quality processes and provide a point of reference for appraising current processes.

WHO defines Good Manufacturing Practices (GMP) as "that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization."

GMP covers all aspects of the manufacturing process including :

• Defined manufacturing process
• Validated critical manufacturing steps
• Suitable premises, storage, transport, qualified and trained production and quality control personnel
• Adequate laboratory facilities
• Approved written procedures and instructions
• Records to show all steps of defined procedures have been taken
• Full traceability of a product through batch records and distribution records
• Systems for recall and investigation of complaints

Good Laboratory Practice (GLP) is an internationally recognized set of principles, which provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived.

Laboratories undertake studies to generate data, on the basis of which, hazards and risks to users, consumers and others including environment, can be assessed. Studies can be conducted on a variety of subjects including pharmaceuticals, agro-chemical, veterinary medicines, industrial chemicals, cosmetics, food, food additives and biocides.

GLP helps assure regulatory authorities that the data submitted is a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments. The various elements of GLP includes the following :

• Standard Operating Procedures (SOP)
• Statistical procedures for data evaluation
• Instrumentation validation
• Reagent/materials certification
• Analyst certification
• Lab facilities certification
• Specimen/Sample tracking

The 5S Philosophy focuses on effective work place organization and standardized work procedures. 5S simplifies the work environment, reduces waste and non-value activity while improving quality, efficiency and safety.

It takes into account the following aspects:

• Space crowded with parts and tools
• Unneeded items stacked between workers
• Excess inventory on the floor
• Excess items and machines make it difficult to improve process flow
• Equipment is dirty and a collection point for miscellaneous materials
• Needed equipment such as tools are difficult to find

Kaizen Japanese Management Concept for Incremental (Gradual, Continuous) Change (Improvement)

• Teamwork
• Personal discipline
• Improved morale
• Quality circles
• Suggestions for improvement

The basic principle used in the implementation of Kaizen concepts are :

• Human resources are most important company assets
• Bringing gradual improvement in the processes rather than making radical changes
• Improvement based on statistical evaluation of process performance

"cGMP," stands for "current Good Manufacturing Practice,"and is an extension of GMP. As per cGMP, it is necessary for the manufacturers, processors and packagers of drugs, medical devices, food and blood, to employ technologies and systems that are up-to-date in order to comply with the existing regulations. cGMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups and errors

Six Sigma is a business process that allows companies to drastically improve their profitability. Six Sigma is a highly controlled methodology. It demands that you choose only the very best projects that meet your company's goals. And once they are chosen, it demands that the proper resources be dedicated to it. It requires the project to be put through an entire process called DMAIC (Define, Measure, Analyze, Improve & Control)

The term “sigma” is used to designate the distribution or spread about the mean (average) of any process.

Six-Sigma is a highly disciplined process that focuses on developing and delivering near-perfect products and services. For a business or manufacturing process, the sigma capability (z-value) is a metric that indicates how well that process is performing. The higher the sigma capability, the better the process in terms of lower defect levels. Sigma capability measures the capability of the process to perform defect- free work. A defect is anything that results in customer dissatisfaction. The central idea behind Six Sigma is that if we can measure how many “defects” we have in a process, we can systematically figure out how to eliminate them and get as close to “zero defects” as possible.

As Defects go down

Six Sigma Capability goes up

Six Sigma means

99% Good Level	Six Sigma Level
20,000 lost articles of mail per hour	Seven lost articles of mail per hour
Unsafe drinking water almost 15 minutes each day	One minute of unsafe drinking water every seven months
5,000 incorrect surgical operations per week	1.7 incorrect surgical operations per week
2 short or long landings at most major airports daily	One short or long landing at most major airports every five years
200,000 wrong drug prescriptions each year	68 wrong drug prescriptions each year
No electricity for almost 7 hours each month	One hour without electricity every 34 years

Six Sigma Philosophy

Some of the key themes of Six Sigma can be summarized as follows:

• Continuous focus on the customer’s requirements
• Using measurements and statistics to identify and measure variation in the production process and other business processes
• Identifying the root causes of problems
• Emphasis on process improvement to remove variation from the production process or other business processes and therefore lower defects and improve customer satisfaction
• Pro-active management focusing on problem prevention, continuous improvement and constantly striving for perfection
• Cross-functional collaboration within the organization
• Setting very high targets

Six Sigma transforms the way a company thinks and works on major business issues:

• Process design: Designing production processes to have the best and most consistent outcomes from the beginning.
• Variable investigation: Conducting studies to identify what variables cause variation and how they interact with each other.
• Analysis and reasoning: Using facts and data to find the root causes of variations, instead of educated guesses or intuition.
• Focus on process improvement: Focusing on process improvement as key to excellence in quality.
• Pro-activeness: Encouraging people to be pro-active about preventing potential problems instead of waiting for problems to occur.
• Broad participation in problem solving: Getting more people involved in finding causes and solutions for problems.
• Knowledge sharing: Learning and sharing new knowledge in terms of best practices to speed up overall improvement.
• Goal setting: Aiming at stretching goals, instead of “good enough” targets, so that the company is constantly striving for improvement.
• Suppliers: Cost is not the only criteria for vendor evaluation, but relative capability to consistently provide quality materials with the shortest lead-time.
• Data based decision-making: Decisions are made based on critical analysis of facts and data. However, this does NOT mean it will negatively impact to a company’s ability to make quick decisions. In contrast, by smoothly applying the DMAIC principles, the decision makers are more likely to have the data they need in order to make well-informed decisions.

About the Training and Certification Programs on Six Sigma:

Absolute Solutions in collaboration with Confluence is delivering Six Sigma Black Belt and Green Belt Training and Certification Programs on the following modes:
1. Open Workshops
2. In-house Programs delivered at spaced intervals to ensure learning and implementation, leading to developing working knowledge & build capabilities on the concepts of six sigma.
3. Six Sigma Training Delivery Model is depicted below:

Electrical Safety audit is a systematic procedure to evaluate potential hazards and to recommend measures to minimize / prevent hazards. This is a loss prevention program that covers- property/production loss, loss of life/injuries to personnel /animals. Electrical safety audit is specific on hazards of electrical origin. Observations can be classified into 5 major areas:
i)Design features
ii)Maintenance aspects
iii)Training needs
iv) Facilities & Procedures
v) Management Commitment

Recommendations as identified in the audit shall be implemented on a time bound programme and shall be closely monitored for timely completion.

An energy audit is a preliminary activity towards instituting energy efficiency programs in an establishment. It consists of activities that seek to identify conservation opportunities preliminary to the development of an energy savings program. To establish the correct energy efficiency program, you have to know first which areas in your establishment unnecessarily consume too much energy, e.g. which is the most cost-effective to improve. An energy audit identifies where energy is being consumed and assesses energy saving opportunities - so you get to save money where it counts the most.

In the factory, doing an energy audit increases awareness of energy issues among plant personnel, making them more knowledgeable about proper practices that will make them more productive. An energy audit in effect gauge the energy efficiency of your plant against “best practices”. When used as a “baseline” for tracking yearly progress against targets, an energy audit becomes the best first step towards saving money in the production plant.