Monday, December 27, 2010

Why Implement ISO 14001 Environmental Management System?


All business, regardless of size and activity, has some impact on the environment. An Environment Management System (EMS) is a tool that allows a company identify and address their particular environmental impacts.

Environmental issues should not be considered in isolation to other management issues. By adopting an EMS a company is making a commitment to incorporate environmental issues into existing management systems.

Environmental management is based on the concept of continuous improvement in environmental performance over time. An EMS will continuously change as a company changes, for example as a business expands and takes on new staff. The EMS must also take account of external factors, such as changes in environmental legislation, technology, and market competition.

Ultimately the aim of the environmental management approach adopted by a company is to prevent or minimise the environmental impacts of operations, while retaining competitiveness. Environmental management is more than simply managing environmental impacts after they are created. Effective environmental management should aim to prevent or minimise the environmental impacts in the first place.

All companies are under increasing pressure to ensure the proper management of the environmental impacts of their activities. Small businesses are subject to increasingly stringent environmental legislation, reflecting the increasing importance of environmental issues in political debate. Customers, suppliers, staff and the general public increasingly demand a commitment from business to better manage the environmental impacts of their activities.

Benefits of an EMS include:

- Cost savings from reduced raw material and resource consumption, e.g. better management of your energy and water needs and consumption.

- Reduced waste collection, treatment and disposal costs.

- Compliance with legal obligations.

- Reduced risk and liability associated with poor environmental performance.

- Improved relationships with key stake holders e.g. customers, suppliers, staff, regulatory authorities and local communities.

Third Party Certification of ISO 14001 Standards


A recognised international accredited EMS standard such as ISO 14001 is a positive message that can be easily conveyed and recognised by customers, suppliers, staff, investors, local authorities and other regulators.

However a company does not necessarily require third part certification for its EMS. A company EMS is a system designed to best meet the specific requirements of that particular company.

Third party certification does provide a useful support or framework within which to develop an EMS. By achieving an internationally recognised EMS standard, a company demonstrates an ongoing commitment to external stakeholders to manage its environmental impacts in a responsible manner. If a company decides not to develop an EMS that meets an accredited standard, the framework provided by these standards may still be useful as a starting point to developing an effective EMS tailored to the specific requirements of a company.

The International Standards Organisation (ISO) international accredited standard for environmental management, the ISO
14001, is the most widely used and accepted EMS standard. This standard is voluntary, certifiable and is accepted by
stakeholders across the world as the preferred model for environmental management.
The European Union recognises ISO 14001 which is considered a stepping stone for the EU Eco-Management and Audit Scheme (EMAS). EMAS is a management tool for companies to evaluate, report and improve their environmental performance, incorporating the ISO14001 environmental management system. Participation in EMAS is voluntary.

Read more on ISO 9001 Standards at http://www.iso9001store.com

Basic Steps in Environmental Management System

1. Preparation
- Consult and involve all staff at an early stage. This may include discussion and training sessions on environmental issues to encourage involvement and better awareness and understanding.
- Identify staff with knowledge/expertise/understanding of environmental issues within the company.
- Assign responsibility to one member of staff or a team.
- Identify external expertise and support e.g. Enterprise Ireland provide funding towards meeting the costs of hiring an external consultant to assist in the installation of an EMS.
- Identify environmental objectives to be achieved.
- Develop an environmental action plan to achieve these environmental objectives.
2. Identifying the Environmental Impacts
Before a company can begin to better manage its environmental impacts it must first identify and quantify the issues. An environmental audit will help identify the key environmental impacts of company activities. This may include:
- Raw materials used, e.g. use of nonrenewable resources and hazardous chemicals.
- The production process, e.g. waste generated, air, noise and water emissions.
- Distribution of goods e.g. fossil fuels used in transport of raw materials and final product.
- Use of final products, e.g. what packaging is necessary.
- End of life, e.g. collection, recycling and disposal.
As you undertake your environmental audit you should also consider:
- Your environmental legal obligations
- Market and financial pressures for improving environmental performance, e.g. have any of your competitors achieved certification to the international EMS standard ISO 14001?
3. Opportunities to prevent and minimise environmental impacts
Set realistic objectives and targets for improving your environmental performance as part of an action plan.

Read more on ISO 9001 Standards at http://www.iso9001store.com

Sunday, November 7, 2010

Document Control System in Manufacturing Industry


Document Control System In Manufacturing Industry

Many traditional paper documents would be generated in a manufacturing business as in the examples listed below:

  • Statutory documents such as licenses, records and reports
  • Transactional documents such as purchase and sales invoices, shipping documents and cash vouchers
  • Production related documents such as operations manuals, specification sheets, production and maintenance schedules, machine production reports, material handling documents, store bin cards and gate passes
  • Management reports where the recipient prefer printed paper documents to computer screen views
  • Business documents such as correspondence, contracts, brochures and reference materials

However, in a modern system, the majority of documents would be generated as computer documents, and remain as such. Different kinds of databases like financial accounts, inventory records and different kinds of analyses are examples. The core functions outlined in the previous section would each produce a continuing flow of voluminous documents.

In addition to providing management information, document management systems also do the following:

  • Ensure that only authorized persons are able to access sensitive documents
  • Minimize the danger of damage and loss of important documents
  • Preserve the documents as long as needed by statute or for management purposes

Records Required by ISO 9001 Standard

Records Required by ISO 9001 Standard
ISO 9000 requires that records be kept of critical operations. Record keeping is the fourth tier of required documentation in ISO 9000, following the Quality Policy Manual, Procedures, and Work Instructions.
Questions you may have include:
•What is a record?
•What are the required records?
•What is the reason for these records?
This lesson will answer those questions. There is a mini-quiz near the end of the lesson.
What is a record?
Records consist of any historical documentation, such as summaries or meetings and reviews, specifications, invoices, results of tests and such. This is different than procedures and instructions that tell what do to. Instead, a record is the history of what has been done.
Records required
The following lists the records required under ISO 9001 version 2000, along with the referring sub-paragraph number from the standard. ISO 9002 and ISO 9003 would be subsets of this list. Of course, a company may choose to include additional records that they deem important.
Para.
Record Required
5.6.1
Management reviews
6.2.2 (e)
Education, training, skills and experience
7.1 (d)
Evidence that the realization processes and resulting product fulfill requirements
7.2.2
Results of the review of the requirements relating to the product and actions arising from the review
7.3.2
Design and development inputs
7.3.4
Results of design and development reviews and any necessary action
7.3.5
Results of design and development verification and any necessary action
7.3.6
Results of design and development validation and any necessary action
7.3.7
Results of the review of design and development changes and any necessary action
7.4.1
Results of supplier evaluations and actions arising from evaluations
7.5.2 (d)
As required by the organization to demonstrate the validation of processes where subsequent monitoring and measurement cannot verify the resulting output
7.5.3
Unique identification of the product, where traceability is a requirement
7.5.4
Customer property that is lost, damaged, or otherwise found to be unsuitable for use
7.6 (a)
Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6
Validity of previous results when measuring equipment is found not to conform to its requirements
7.6
Results of calibration or verification of measuring equipment
8.2.2
Internal audit results
8.2.4
Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product
8.3
Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2
Results of corrective actions
8.5.3
Results of preventive actions
Reason for records
The reason to keep records is for future use as a reference in case of questions related to contractual and legal matters, work techniques, verification of work done, and other parts essential to the company running smoothly. The company management should use sound judgment as to what records are non-essential and how long to keep a specific record.

Records Required by ISO 9001 Standard

Records Required by ISO 9001 Standard
ISO 9000 requires that records be kept of critical operations. Record keeping is the fourth tier of required documentation in ISO 9000, following the Quality Policy Manual, Procedures, and Work Instructions.
Questions you may have include:
•What is a record?
•What are the required records?
•What is the reason for these records?
This lesson will answer those questions. There is a mini-quiz near the end of the lesson.
What is a record?
Records consist of any historical documentation, such as summaries or meetings and reviews, specifications, invoices, results of tests and such. This is different than procedures and instructions that tell what do to. Instead, a record is the history of what has been done.
Records required
The following lists the records required under ISO 9001 version 2000, along with the referring sub-paragraph number from the standard. ISO 9002 and ISO 9003 would be subsets of this list. Of course, a company may choose to include additional records that they deem important.
Para.
Record Required
5.6.1
Management reviews
6.2.2 (e)
Education, training, skills and experience
7.1 (d)
Evidence that the realization processes and resulting product fulfill requirements
7.2.2
Results of the review of the requirements relating to the product and actions arising from the review
7.3.2
Design and development inputs
7.3.4
Results of design and development reviews and any necessary action
7.3.5
Results of design and development verification and any necessary action
7.3.6
Results of design and development validation and any necessary action
7.3.7
Results of the review of design and development changes and any necessary action
7.4.1
Results of supplier evaluations and actions arising from evaluations
7.5.2 (d)
As required by the organization to demonstrate the validation of processes where subsequent monitoring and measurement cannot verify the resulting output
7.5.3
Unique identification of the product, where traceability is a requirement
7.5.4
Customer property that is lost, damaged, or otherwise found to be unsuitable for use
7.6 (a)
Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6
Validity of previous results when measuring equipment is found not to conform to its requirements
7.6
Results of calibration or verification of measuring equipment
8.2.2
Internal audit results
8.2.4
Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product
8.3
Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2
Results of corrective actions
8.5.3
Results of preventive actions
Reason for records
The reason to keep records is for future use as a reference in case of questions related to contractual and legal matters, work techniques, verification of work done, and other parts essential to the company running smoothly. The company management should use sound judgment as to what records are non-essential and how long to keep a specific record.

ISO 9000 Document Control Procedures


ISO 9000 Standards Document control procedures
The ISO 9000 Standards requires that a documented procedure be established to define the controls needed.

This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.

Although the ISO 9000 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.

Documents are recorded information and the purpose of the document control process is to firstly ensure the appropriate information is available where needed and secondly to prevent the inadvertent use of invalid
information. At each stage of the process are activities to be performed that may require documented procedures in order to ensure consistency and predictability. Procedures may not be necessary for each stage in the process.


Different Between Quality Assurance & Quality Control

QA: Quality Assurance is the process which are having their eyes on the process to provide the assurity of the quality. like doing the testing at the time of development, giving the review comments and forced the developers to fixed the defects of the requirement, designed, coding and testing phase is the Quality Assurance.

Quality Control: Before delivering the product to make sure that all the documentation are provided, product has meet with the requirement criteria, all the SDLC phase are met with the exit criteria is the Quality control.

Difference between Quality Control and Quality Assurance?

Quality ControlQuality Assurance
DefinitionQC is about checking at the end of some development process (e.g. – a design activity) that we have built quality in i.e. that we have achieved the required quality with our methods.QA is about having an overall development and management process that provides right environment for ensuring quality of final product.
DescriptionQC is like testing a module against requirement specification or design document, measuring response time, throughput etc.QA gives us added assurance that the whole producing or checking process is properly planned and executed and thus maintaining high quality.
What it doesTo check that the modern methods of software development are largely designed to ensure right quality is achieved. QC checks that these methods are in place and to discover where they are not then corrections are to be made.It gives us added assurance that the while producing / checking process is being properly planned and executed and hence is keeping high our chances of producing software of required quality.
StagesDefine features and levels Define feature check procedure Carrying out the check procedure Record the result take and record any corrective action taken.1. Determination of quality policy through Quality Management System 2. Checking that predetermined Quality control activities are being properly taken care off.
Best carried out onQC is best carried out on productsQA is best carried out on process.
Phase of implementationQC should take place at every stage of SDLC.QA should be done at end of every SDLC i.e. when product building is complete.
TechniqueStructured walkthrough, Fagan Techniques are some of QC techniques.Quality policy defined and generally implemented in the form of Quality Management System is used to carry out QA.

As per ISO 9000 Standards:

Quality Control means – The Operational Techique and activities that are used to fullfill requirements of Quality,

Quality Assurance means – All Those planned and systematic activites implemented already , to provide adequate confidence that an entity will fulfillrequirements of Quality.

The following table can explain in detail:

QC QA

Product Process

Reactive Pro-active

Line Function Staff Function

Find the defects Prevent the defects

e.g.

QC QA

Walkthrough Quality Audit

Testing Defining Process

Inspection Selection of tools

Checkpoint Review Trainings

Different Between Quality Assurance & Quality Control

QA: Quality Assurance is the process which are having their eyes on the process to provide the assurity of the quality. like doing the testing at the time of development, giving the review comments and forced the developers to fixed the defects of the requirement, designed, coding and testing phase is the Quality Assurance.

Quality Control: Before delivering the product to make sure that all the documentation are provided, product has meet with the requirement criteria, all the SDLC phase are met with the exit criteria is the Quality control.

Difference between Quality Control and Quality Assurance?

Quality ControlQuality Assurance
DefinitionQC is about checking at the end of some development process (e.g. – a design activity) that we have built quality in i.e. that we have achieved the required quality with our methods.QA is about having an overall development and management process that provides right environment for ensuring quality of final product.
DescriptionQC is like testing a module against requirement specification or design document, measuring response time, throughput etc.QA gives us added assurance that the whole producing or checking process is properly planned and executed and thus maintaining high quality.
What it doesTo check that the modern methods of software development are largely designed to ensure right quality is achieved. QC checks that these methods are in place and to discover where they are not then corrections are to be made.It gives us added assurance that the while producing / checking process is being properly planned and executed and hence is keeping high our chances of producing software of required quality.
StagesDefine features and levels Define feature check procedure Carrying out the check procedure Record the result take and record any corrective action taken.1. Determination of quality policy through Quality Management System 2. Checking that predetermined Quality control activities are being properly taken care off.
Best carried out onQC is best carried out on productsQA is best carried out on process.
Phase of implementationQC should take place at every stage of SDLC.QA should be done at end of every SDLC i.e. when product building is complete.
TechniqueStructured walkthrough, Fagan Techniques are some of QC techniques.Quality policy defined and generally implemented in the form of Quality Management System is used to carry out QA.

As per ISO 9000 Standards:

Quality Control means – The Operational Techique and activities that are used to fullfill requirements of Quality,

Quality Assurance means – All Those planned and systematic activites implemented already , to provide adequate confidence that an entity will fulfillrequirements of Quality.

The following table can explain in detail:

QC QA

Product Process

Reactive Pro-active

Line Function Staff Function

Find the defects Prevent the defects

e.g.

QC QA

Walkthrough Quality Audit

Testing Defining Process

Inspection Selection of tools

Checkpoint Review Trainings

Advantages Of ISO 9001 Standard

Successful firms are good at two things: increasing sales and reducing costs. However, these two things may prove irrelevant if the quality of the product or service is poor. ISO 9001 Standard is concerned with improving the quality of operations which can affect both top and and bottom line growth. Implementation of ISO 9001 Standard affects the entire organization by providing a transition to both a new common language and a new way of thinking about continuous process improvement. Here’s how you can bring the benefits of ISO 9001 Standard to your organization.

1. Obtain management buy-in. The most important step to any quality initiative is to obtain management commitment. This will increase both the visibility and awareness of your efforts.

2. Create an implementation team. This should include a representative from all functional areas of the organization including marketing, finance, planning, production and design. Also be sure to assign a Management Representative. This should be your strongest upper-level advocate for the success of ISO 9001 Standard implementation.

3. Communicate the goals of the program and provide training. This should include employees as well as major suppliers. The communication should be concise, tied to improving the success of current goals and objectives, and in a language in which employees are familiar with.

4. Map out the most critical processes of the current system. Use an organizational flow chart to show how information flows from the placement of an order to delivery. Compare this flowchart with the ISO 9001 system (see Resources for a link to Management Standards) and identify areas for improvement.

5. Create an implementation plan based on opportunities for improvement found in Step 4. The plan should be thorough and specific. Document each change in the process flowchart. If you already have documentation supporting your processes, use it. However, if you identify an area which lacks documentation, this should be viewed as an opportunity. Documentation is the lifeblood of continuous improvement. If you don’t already have one, create a documentation control system which manages the creation, approval, distribution, storage and disposal of documents.

6. Report out on improvements, create metrics to track improvements and repeat the process. ISO 9001 Standard is about continuous process improvements, and the success of the program is a function of both commitment and the achievement of this goal.

Advantages Of ISO 9001 Standard

Successful firms are good at two things: increasing sales and reducing costs. However, these two things may prove irrelevant if the quality of the product or service is poor. ISO 9001 Standard is concerned with improving the quality of operations which can affect both top and and bottom line growth. Implementation of ISO 9001 Standard affects the entire organization by providing a transition to both a new common language and a new way of thinking about continuous process improvement. Here’s how you can bring the benefits of ISO 9001 Standard to your organization.

1. Obtain management buy-in. The most important step to any quality initiative is to obtain management commitment. This will increase both the visibility and awareness of your efforts.

2. Create an implementation team. This should include a representative from all functional areas of the organization including marketing, finance, planning, production and design. Also be sure to assign a Management Representative. This should be your strongest upper-level advocate for the success of ISO 9001 Standard implementation.

3. Communicate the goals of the program and provide training. This should include employees as well as major suppliers. The communication should be concise, tied to improving the success of current goals and objectives, and in a language in which employees are familiar with.

4. Map out the most critical processes of the current system. Use an organizational flow chart to show how information flows from the placement of an order to delivery. Compare this flowchart with the ISO 9001 system (see Resources for a link to Management Standards) and identify areas for improvement.

5. Create an implementation plan based on opportunities for improvement found in Step 4. The plan should be thorough and specific. Document each change in the process flowchart. If you already have documentation supporting your processes, use it. However, if you identify an area which lacks documentation, this should be viewed as an opportunity. Documentation is the lifeblood of continuous improvement. If you don’t already have one, create a documentation control system which manages the creation, approval, distribution, storage and disposal of documents.

6. Report out on improvements, create metrics to track improvements and repeat the process. ISO 9001 Standard is about continuous process improvements, and the success of the program is a function of both commitment and the achievement of this goal.