NON ISO STANDARDS

CE MARK

Europe is a competitive but prize market, easier to access than ever before. Too many Indian exporters, especially small and medium sized enterprises, avoid it because the technical requirements for entry seem too complicated, too difficult, or too expensive. Indian manufacturers who have successfully accessed the European market know that the time to understand the European system is well worth the effort. The European Union alone is filled with affluent consumers, approximately 450 million of them. The European market is a large area that comprises more than 25 countries.

For the exporter, therefore, Europe as a whole has become a market whose technical requirements have been greatly simplified. Before the creation of the European Union, each country imposed its own technical requirements. Different standards and conformity assessment procedures forced exporters to target one or two countries only, or to forego exporting to Europe altogether. The unification of these European countries into a European Union, and the consequent harmonization of laws, standards, and conformity assessment procedures, changed all that.

Perhaps more importantly, ISO 9001 Certification is used extensively in Europe as a condition of acceptance of a manufacturer’s product or as a means of recognition of the manufacturer’s credibility. It is important to note that a manufacturer with a quality system in place (such as ISO 9001 QMS) should not automatically assume that his or her products are CE compliant because of the quality system alone. The appropriate New Approach Directive(s) will prescribe the correct and full route to conformity assessment.

The CE Mark, which is affixed to a product or its packaging, is considered proof that a product has met the requirements of the harmonized European standard, or directive; refers to Communauté Européen. Translated from the French, this literally means European Community. The European Commission, which administers the program, describes the CE Mark as a passport for goods to be sold freely within the internal European market. It is required by law if the product falls under one of the New Approach Directives. It is not a quality mark, nor is it a mark for consumers. Intended for Member State authorities, it is the visible sign to those authorities that your product is in compliance with the New Approach Directives. All manufacturers are required to affix the CE mark to products that are governed by New Approach Directives. CE marking on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product.

The first step to compliance is determining which directives apply to the product. A product may be regulated by more than one directive. The CE mark does not disclose which directive(s) or standards apply to the product, nor will it indicate the method of conformity assessment used to bring the product into compliance. This information is provided by other accompanying documents, such as the Declaration of Conformity. The Manufacturer or the Authorized Representative affixes the CE marking to the product. It is not affixed by a Notified Body.

List of New Approach directives for CE Marking

2006/95/EEC Low Voltage Equipment (LVD)
87/404/EEC Simple Pressure Vessels
88/378/EEC Toys Safety
89/106/EEC Construction Products
89/336/EEC Electromagnetic Compatibility (EMC)
89/686/EEC Personal Protective Equipment (PPE)
90/384/EEC Non-Automatic Weighing Instruments
90/385/EEC Medical Devices – Active Implantable
90/396/EEC Appliances Burning Gaseous Fuels
92/42/EEC New Hot-Water Boilers fired with Liquid or Gaseous Fuels (Efficiency Requirements)
93/15/EEC Explosives for Civil Uses
93/42/EEC Medical Devices – General (MDD)
94/9/EC Equipment and Protective Systems in Potentially Explosive Atmospheres (ATEX)
94/25/EC Recreational Craft
94/62/EC Packaging and Packaging Waste
95/16/EC Lifts
2014/68/EU Pressure Equipment (PED)
98/37/EC Machinery Safety
98/79/EC Medical Devices – In Vitro Diagnostic (IVD)
99/5/EC Radio Equipment and Telecommunications Terminal Equipment
00/9/EC Cableway Installations designed to Carry Persons
04/22/EC Measuring Instruments
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GMP / GLP / GPP
W.H.O. 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: 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 taken; full traceability of a product through batch processing records and distribution records; and systems for recall and investigation of complaints.

The guiding principle of GMP is that quality is built into a product, and not just tested into a finished product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. There are many ways this is controlled – controlling the quality of the facility and its systems, controlling the quality of the starting materials, controlling the quality of production at all stages, controlling the quality of the testing of the product, controlling the identity of materials by adequate labeling and segregation, controlling the quality of materials and product by adequate storage, etc. All of these controls must follow prescribed, formal, approved procedures, written as protocols, SOPs, or Master Formulae, describing all the tasks carried out in an entire manufacturing and control process.

HACCP

Hazard Analysis and Critical Control Points (HACCP) is a prevention-based food safety system. It provides a systematic method for analyzing food processes, determining the possible hazards and designating the critical control points necessary to prevent unsafe food from reaching the consumer.

HACCP is built around seven principles:

Analysis of food hazards: biological, chemical or physical
Identification of critical control points: raw materials, storage, processing, distribution and consumption.
Establishment of critical control limits and preventive measures: for example, minimum cooking temperature and time.
Monitoring of these critical control points.
Establishment of corrective actions.
Keeping records.
Systematic and regular auditing of the system in place by independent third party certification bodies.

Benefits of Implementing HACCP

In addition to meeting the legal and moral obligation to produce food that is safe to eat, HACCP offers a variety of other benefits for not only the consumer, but for the food industry and the government. The following are examples of benefits that may be gained by implementing a HACCP program.

HACCP can be applied throughout the food chain from the primary producer to final consumer.

HACCP reduces the need for finished product testing by identifying the hazards associated with the inputs into the process and the product and devising control measures which can be monitored in order to minimize or eliminate the hazards.

A HACCP program, when properly designed and implemented, will significantly reduce the chance of microbiological, chemical, and physical contaminants from reaching the customer.

HACCP can reduce regulatory involvement (and hence costs) by replacing on-line inspection with regular auditing.

HACCP principles can be applied to other aspects of food quality and regulatory requirements.

Since HACCP increases one’s ability to detect poor quality product during production, such product can be held before further value is added. Resources are saved and faulty product is not produced. Productivity and profitability is improved.

HACCP improves communications between supplier and customer. It encourages businesses to work together more closely and to help them understand each other’s capacity and requirements.

HACCP is capable of accommodating changes such as advances in raw materials, equipment and premise design, procedures, and technological developments.

Communication between the different segments of the food chain improves as HACCP provides a common language and a common focus on quality.

Improved customer confidence leads to increased market share.

SA 8000

The SA 8000 certification is the Social Accountability System standard. It is applicable to companies of any size that wish to address the social and ethical aspects of their business. A Social Accountability System proves to customers that the company holds adequate provisions for the protection of wokers’ rights. Further, it ensures ethical production of all goods manufactured by the company.

SA 8000 is the first auditable standard in this field. The initiative is based on the well-known ISO 9001/ISO 14001 certification structure, conventions of the International Labour Organization (ILO), the Universal Declaration of Human Rights and the UN Convention on the Rights of the Child.

SA 8000 KEY REQUIREMENTS

Be senior management led.
Be focused on continuous improvement.
Be focused on prevention rather than reaction.
Be supportive of workers’ rights and workers participation.
Be compliant with local laws/codes.
Be proactive in promoting ethical sourcing.
Be systematic in addressing problems-CARs Process.

Benefits of SA 8000 to manufacturers and suppliers

Marketing advantage – more demand and value for goods from socially..
Responsible manufacturers/suppliers.
Enhancement of company’s productivity.
Compliance to the laws of the land.
Improvement of relationship with the Govt., NGOs, trade unions.
Better image and position in labour market.

Benefits of SA 8000 for the retailers

Cost reduction in monitoring.
Better corporate image.
Increased value for the products.
Trust building with the analysts and investors when evaluated against social performance.
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PED (PRESSURE EQUIPMENT DIRECTIVE)
The Pressure Equipment Directive is an EU New & Global Approach Product Directive.

The PED lays down requirements for the design and manufacture of pressure equipment and assemblies with a maximum allowable pressure greater than 0.5 bar gauge (1.5 bar absolute).

Vessels, piping, safety accessories and pressure accessories are included in the scope of the Directive but there are also many excluded products.

Products within the scope of the Directive must comply at the first “putting on the market” or “putting into service” in EEA.

AD 2000

The German pressure vessel association published a regulation conform to the Pressure Equipment Directive 2014/68/EU called AD 2000.

The purpose of ISO 50001: 2011 is to enable an organization to achieve continual improvement in its energy use and consumption or energy performance through a systematic approach. ISO 50001:2011 does not define specific energy consumption criteria but requires organizations to define its energy performance indices and targets and achieve them by implementing a proper action plan.

In general the harmonized European Standard DIN EN 13445 can be used for unfired pressure vessels. The final release of this standard is implemented since May 2002 Designing according to this standard is an advantage if you have customers all over Europe.

What are the advantages of the AD 2000?

Germany has the largest market in the EU.
The German Regulations are accepted by most of the European neighbors.
The German regulations are the “toughest” in Europe, an approval according the German Pressure Vessel.
Code will be the base for a future EU-Approval.
Evidence for the delivery ability of quality products Marketing effect with TUV-certificate.
Listed on VdTUV-Merkblatt1253.
Documentation of material test in accordance with the standard.

CMMI

It is a guide for implementing development practices that continuously improve software quality. This has been created by SEI (Software Engineering Institute) – a research and development centre operated by Carnegie Mellon University.

“CMMI” refers to the integration of diverse tool sets and appraisal methods related to CMM. CMMi builds on and extends on the best practices of the:

Capability Maturity Model for Software (SW-CMM)
Systems Engineering Capability Model (SECM)
Integrated Product Development Capability Maturity Model (IPD-CMM)
Supplier Sourcing Capability Maturity Model (SS-CMM)

CMMi will help Software and Systems Engineering Companies to Study, Define, Implement, Improve and Appraise their internal Processes to result in improvement of the Development Cycle Time, Timely deliveries to Customers, Reduction in Schedule, Effort and Cost variances, reduced Defect levels, reduced Rework, improved Productivity and Profitability.

CMMI Maturity Levels There are 5 maturity levels viz.

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Initial
Managed
Defined
Quantitatively Managed
Optimizing
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SIX SIGMA
What is Six Sigma?

Six sigma is the structured application of tools and techniques applied on project basis to achieve sustained strategic results.

DMAIC six sigma approach

The six sigma approach for projects is DMAIC (define, measure, analyze, improve and control). These steps are the most common six sigma approach to project work. Some organizations omit the D in DMAIC because it is really management work. With the D dropped from DMAIC the Black Belt is charged with MAIC only in that six sigma approach. We believe define is too important be left out and sometimes management does not do an adequate job of defining a project. Our six sigma approach is the full DMAIC.

Define (DMAIC)

Define is the first step in our six sigma approach of DMAIC. DMAIC first asks leaders to define our core processes. It is important to define the selected project scope, expectations, resources and timelines. The definition step in the six sigma approach identifies specifically what is part of the project and what is not, and explains the scope of the project. Many times the first passes at process documentation are at a general level. Additional work is often required to adequately understand and correctly document the processes.

Measure (DMAIC)

Many think when they start a journey the most important thing to know is where they are going. While we agree knowing where you want to go is very important, we believe some of the first information you need before starting any journey is your current location. The six sigma approach asks the Black Belt project manager to quantify and benchmark the process using actual data. At a minimum consider the mean or average performance and some estimate of the dispersion or variation (maybe even calculate the standard deviation). Trends and cycles can also be very revealing. The two data points and extrapolate to infinity is not a six sigma approach. Process capabilities can be calculated once there is performance data.

Analyze (DMAIC)

Once the project is understood and the baseline performance documented and verified that there is real opportunity, it is time with the six sigma approach to do an analysis of the process. In this step, the six sigma approach applies statistical tools to validate root causes of problems. Any number of tools and tests can be used. The objective is to understand the process at a level sufficient to be able to formulate options for improvement. We should be able to compare the various options with each other to determine the most promising alternatives. As with many activities, balance must be achieved. Superficial analysis and understanding will lead to unproductive options being selected, forcing recycle through the process to make improvements. At the other extreme is the paralysis of analysis. Striking the appropriate balance is what makes the six sigma Black Belt highly valuable.

Improve (DMAIC)

During the improve step of the six sigma approach ideas and solutions are put to work. The six sigma Black Belt has discovered and validated all known root causes for the existing opportunity. The six sigma approach requires Black Belts to identify solutions. Few ideas or opportunities are so good that all are an instant success. As part of the six sigma approach there must be checks to assure that the desired results are being achieved. Some experiments and trials may be required in order to find the best solution. When making trials and experiments it is important that all project associates understand that these are trials and really are part of the six sigma approach.

Control (DMAIC)

Many people believe the best performance you can ever get from a process is at the very beginning. Over time there is expectancy that slowly things will get a little worse until finally it is time for another major effort towards improvement. Contrasted with this is the Kaizen approach that seeks to make everything incrementally better on a continuous basis. The sum of all these incremental improvements can be quite large. As part of the six sigma approach performance tracking mechanisms and measurements are in place to assure, at a minimum, that the gains made in the project are not lost over a period of time. As part of the control step we encourage sharing with others in the organization. With this the six sigma approach really starts to create phenomenal returns, ideas and projects in one part of the organization are translated in a very rapid fashion to implementation in another part of the organization.

Benefits of Six Sigma

There are numerous benefits of six sigma as a way to address issues and problems. Among the benefits of six sigma is the decrease in defects that are allowed to reach the customer. You can get some sense of the benefits of six sigma by reviewing some six sigma projects. Other benefits of six sigma include:

Focus on customers.
Improved customer loyalty.
Reduced cycle time.
Less waste
Data based decisions.
Time management.
Sustained gains and improvements.
Systematic problem solving.
Employee motivation.
Data analysis before decision making.
Faster to market.
Team building.
Improved customer relations.
Assure strategic planning.
Reductions of incidents.
Measure value according to the customer.
Better safety performance.
Understanding of processes.
Effective supply chain management.
Design and redesign products/services.
Knowledge of competition, competitors.
Develop leadership skills.
Breakdown barriers between departments and functions.
Management training.
Improve presentation skills.
Integration of products, services and distribution
Use of standard operating procedures.
Better decision making.
Improving project management skills.
Sustained improvements.
Alignment with strategy vision, and values.
Increased margins.
Greater market share.
Supervisor training.
Lower costs to provide goods and services.
Fewer customer complaints.
To know more about Six Sigma and our deliverables through our unique process approach, click here or contact us for a Zero Cost discussion.