Monday, May 16, 2011

ISO14001: A Deterrent against Environmental Degradation

Over the last few years, ISO 14001 has gained considerable support of business communities and governments worldwide. Business communities consider it a catalyst which ensures continued business and provides an opportunity to boost trade with customers overseas. Governments look at it as a useful agent to soften the local industry to comply with environmental legislation.
ISO 14001 is being pushed as an agenda, therefore, which will help in lowering environmental impacts that occur because of the manufacturing sector. On the surface, the picture is quite rosy.
For large manufacturers adopting ISO 14001 is quite practical and makes economic sense. The major assumption while formulating the ISO 14001 was that there is no informal manufacturing sector (because of poor representation and inactive role of the developing countries at TC207). Informal sector in Pakistan is a major component of the manufacturing sector and provides useful support to the formal sector. The informal sector exists within the populated areas, making it extremely hard to regulate. Therefore, the environmental impacts due to this sector are quite significant.
ISO 14001 requires the suppliers of a manufacturer to have an Environmental Management System (EMS) in place as well. For a supplier operating from a small facility in a congested area and meager resources, how can s/he be expected to hire a consultant to develop an EMS? In a country which has a significant informal manufacturing sector, high unemployment due to deteriorating economic condition, high inflation, limited resources, weak monitoring agencies and deteriorating infra-structure, with all these constraints, how is it possible for the manufacturing sector to adopt ISO 14001 in it’s true spirit?
Even if a manufacturer adopts the ISO 14001, what is the guarantee that s/he will get business? What is the incentive for the non-exporting manufacturers to adopt ISO 14001? How can the industry be convinced that ISO 14001 is an opportunity not an obstacle? Considering all these factors, this paper will analyze the current status of ISO 14001 adoption in Pakistan, reasons for adoption, deterrents in adoption, and recommendations on how those deterrents can either be removed or minimized, and it’s overall impact on the environment and economy.

Monday, February 28, 2011

Internal Audit In ISO 9001:2008 Standards

ISO stands for International Organization for Standardization. ISO is a non governmental organization based in Geneva Switzerland which promulgates worldwide commercial and industrial standards. TheISO 9000 is a family of standards set for quality management systems. If a company has the ISO 9001: 2008 certificate, they are said to be ISO 9001:2008 compliant and would have followed a formal procedure of training and auditing to get the certificate.
Courses usually take place in a classroom setting, but some can be conducted online, like the course provided by the Telecom Quality Management System. In general, courses cover customer satisfaction, quality control, quality assurance and ensuring supplier quality. Courses often take the form of lectures and case studies to enable students to understand international standards and follow processes and procedures. Some courses train students on ISO auditing procedures, ISO quality management techniques and ISO certification. The American Society for Quality provides a program which leads to certification.
Companies that produce products, services or software can use ISO 9001 processes to improve their business operations to ensure that the products they produce are of the highest quality. Candidates trained in ISO 9001 standards are able to identify problems, create solutions and therefore implement good quality management practices. Candidates are also able to examine work flow, eliminate waste and maximize performance and effectiveness, ultimately helping to improve operations within the company.
Effective ISO 9001:2008 training prepares students to deal with the issues that can arise due to non conformance with standards. Such issues may include manufacturing errors. The development of quality control mechanisms according to the standards helps to guard against the risk of damaged products being shipped to customers.
Read more on ISO 9001:2008 at http://www.iso9001store.com

ISO 9001 Equipment Maintenance Procedure

The purpose of this ISO 9001 Standards procedure is to regulate the planning and inspecting maintenance of equipments and machines while implementing process of production industry. The maintenance is to minimize and prevent from unexpected incidents caused by machines influencing the plan and schedule of production.

This procedures include steps as follows:

1. Need of equipment maintenance:

Due to the fact is that maintenance of machines and equipments is very important to the implementation of production industry, so the need of machines maintenance is set up to eliminate and prevent from unexpected incidents by machines and equipments that may affect to the plan and progress of production.

2. Making list of equipments

All machines and equipments that are working are conforming to requirements of production. The maintenance will coordinate with other Heads of departments (HODs) to make a list of each equipment for checking, preparing to replace, or repairing to submit to Technical department for approval.

3. Making a schedule of investigation:

Based on the machines and equipments that are using and depending the capacities and purposes of specialized equipments, the maintenance will make a schedule of investigation accordingly identifying the machines that serve requirements of practical products and give schedule of maintenance periodically or regularly maintained according to frequency of using.

4. Implementation of Investigation:

Based on plan of investigation, the maintenance department will investigate machines and equipment and record clearly:

o The duration of time used
o The duration of time maintained previously
o Trouble shootings earlier.
o Status of machines and equipments.
o Need repairing, replacing or maintenance.

5. Making schedule of maintenance:

After investigation and examination, the maintenance department will review the frequency of using of each machine so as to make a schedule of specific maintenance for each kind of machine and equipment.

o After identifying purpose and the importance of each machine in production, the maintenance department will make a schedule of maintenance for each of equipment as regulated by designers.

6. Material estimate:

Once having schedule of maintenance or repair, the maintenance will inspect to identify the causes leading trouble shootings, make a material estimate request to supply accessories of the equipment that need repairing at definite time. At the same time, there will be supervision and inspection from Head of department where machines or equipments are used.

7. Implementation:

Once having made material estimate and provided, Maintenance Department carry out repair based on the plan of maintenance and approval for repair. After the maintenance is finished, the maintenance will coordinate with the using department to make a report of inspection and evaluating quality of equipment and machines to put into operation and stating clearly about status of equipments that are replaced.

8. Updating files:

When finishing maintenance and repair, the maintenance Dept. will file each of machine whose accessories are repaired and for how long they can work as well as make a file for each machine.

More information on ISO 9001, kindly go to http://www.iso9001store.com

Monday, January 17, 2011

ISO 9000 CERTIFICATION IS AN APPRAISAL TO COMPANY

During World WarII, there were quality problems in many British industries such as munitions, where bombs were exploding in factories during assembly. The adopted solution was to require factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The name of the standard was BS 5750, and it was known as a management standard because it specified not what to manufacture, but how the manufacturing process was to be managed. According to Seddon, “In 1987, the British Government persuaded the International Organization for Standardization to adopt BS 5750 as an international standard. BS 5750 became ISO 9000.”

ISO 9001: 2008 only introduces clarifications to the existing requirements of ISO 9001: 2000 based on eight years of experience of implementing the standard worldwide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001: 2004.. In fact, the ISO technical committee (TC176) who develops the ISO 9000 series of standards is deliberately planning the next release as an amendment rather than a formal revision. The difference is that an “amendment” is focused on making changes for clarification purposes only and for better alignment with ISO 14001, the standard for environmental management. With the 2008 release, the committee is purposely intending not to introduce substantive changes that will affect the QMS processes and documentation of currently certified organizations. Thus, the new ISO 9001:2008 standard should have limited impact on companies already certified. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) include:-

  • a set of procedures that cover all key processes in the business;
  • monitoring processes to ensure they are effective;
  • keeping adequate records;
  • checking output for defects, with appropriate and corrective action where necessary;
  • regularly reviewing individual processes and the quality system itself for effectiveness; and
  • facilitating continual improvement

ADVANTAGES OF ISO 9000 CERTIFICATION:

It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9001: are also sound, according to Wade, and Barnes, who says “ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive.” Barnes also cites a survey by Lloyd’s Register Quality Assurance which indicated that ISO 9001 increased net profit, and another by Deloitte-Touche which reported that the costs of registration were recovered in as less as three months. According to the Providence Business News, implementing ISO often gives the following advantages:

  1. Create a more efficient, effective operation
  2. Increase customer satisfaction and retention
  3. Reduce audits
  4. Enhance marketing
  5. Improve employee motivation, awareness, and morale
  6. Promote international trade
  7. Increases profit
  8. Reduce waste and increases productivity

In today’s service-sector driven economy, more and more companies are using ISO 9000 as a business tool. Through the use of properly stated quality objectives, customer satisfaction surveys and a well-defined continual improvement program companies are using ISO 9000 processes to increase their efficiency and profitability.

Sunday, October 17, 2010

Develop Quality Management System Documentation In ISO 9000 Standards

Develop Quality Management System Documentation In ISO 9000 Standards
Documentation is the most common area of non-conformance among organizations wishing to implement ISO 9000 quality management systems. As one company pointed out: “When we started our implementation, we found that documentation was inadequate. Even absent, in some areas. Take calibration. Obviously it’s necessary, and obviously we do it, but it wasn’t being documented. Another area was inspection and testing. We inspect and test practically every item that leaves here, but our documentation was inadequate”.
Documentation of the quality management system should include:
1. Documented statements of a quality policy and quality objectives,
2. A quality manual,
3. Documented procedures and records required by the standard ISO 9001:2008, and
4. Documents needed by the organization to ensure the effective planning, operation and control of its processes.

Quality documentation is generally prepared in the three levels indicated below that follows. Use ISO 10013:1995 for guidance in quality documentation.

Level A: Quality manual
States the scope of the quality management system, including exclusions and details of their justification; and describes the processes of the quality management system and their interaction. Generally gives an organization profile; presents the organizational relationships and responsibilities of persons whose work affects quality and outlines the main procedures. It may also describe organization’s quality policy and quality objectives.

Level B: Quality management system procedures
Describes the activities of individual departments, how quality is controlled in each department and the checks that are carried out.

Level C: Quality documents (forms, reports, work instructions, etc.)
1. Work instructions describe in detail how specific tasks are performed; include drawing standards, methods of tests, customer’s specifications, etc.
2. Presents forms to be used for recording observations, etc.

ISO 9000 Standards – 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.

Every process is likely to require the use of documents or generate documents and it is in the process descriptions that you define the documents that need to be controlled. Any document not referred to in your process descriptions is therefore, by definition, not essential to the achievement of quality and not required to be under control. It is not necessary to identify uncontrolled documents in such cases. If you had no way of tracing documents to a governing process, a means of separating controlled from uncontrolled may well be necessary.

The procedures that require the use or preparation of documents should also specify or invoke the procedures for their control. If the controls are unique to the document, they should be specified in the procedure that requires the document. You can produce one or more common procedures that deal with the controls that apply to all documents. The stages in the process may differ depending on the type of document and organizations involved in its preparation, approval, publication and use. One procedure may cater for all the processes but several may be needed.
The aspects you should cover in your document control procedures, (some
of which are addressed further in this chapter) are as follows
Planning new documents, funding, prior authorization, establishing need
etc.

- Preparation of documents, who prepares them, how they are drafted,
conventions for text, diagrams, forms etc.
- Standards for the format and content of documents, forms and diagrams.
- Document identification conventions.
- Issue notation, draft issues, post approval issues.
- Dating conventions, date of issue, date of approval or date of distribution.
- Document review, who reviews them and what evidence is retained.
- Document approval, who approves them and how approval is denoted.
- Document proving prior to use.
- Printing and publication, who does it and who checks it.
- Distribution of documents, who decides, who does it, who checks it.
- Use of documents, limitations, unauthorized copying and marking.
- Revision of issued documents, requests for revision, who approves the
request, who implements the change.
- Denoting changes, revision marks, reissues, sidelining, underlining.
Amending copies of issued documents, amendment instructions, and
amendment status.
- Indexing documents, listing documents by issue status.
- Document maintenance, keeping them current, periodic review.
- Document accessibility inside and outside normal working hours.
- Document security, unauthorized changes, copying, disposal, computer
viruses, fire and theft.
- Document filing, masters, copies, drafts, and custom binders.
- Document storage, libraries and archive, who controls location, loan
arrangements.
- Document retention and obsolescence.

With electronically stored documentation, the document database may provide many of the above features and may not need to be separately prescribed in your procedures. Only the tasks carried out by personnel need to be defined in your procedures. A help file associated with a document database is as much a documented procedure as a conventional paper based procedure.

ISO 9000 Standards – Document Approval


ISO 9000 Standards – Document Approval
The ISO 9000 Standards requires that documents be approved for adequacy prior to issue.

Approval prior to issue means that designated authorities have agreed the document before being made available for use. Whilst the term ade-
quacy is a little vague it should be taken as meaning that the document is judged as fit for the intended purpose. In a paper based system, this means approval before the document is distributed. With an electronic system, it means that the documents should be approved before they are published or made available to the user community.

The ISO 9000 Standards document control process needs to define the process by which documents are approved. In some cases it may not be necessary for anyone other than the approval authority to examine the documents. In others it may be necessary to set up a panel of reviewers to solicit their comments before approval is given.
It all depends on whether the approval authority has all the information
needed to make the decision and is therefore ‘competent’. One might think that the CEO could approve any document in the organization but just because a person is the most senior executive does not mean he or she is competent to perform any role in the organization.

Users should be the prime participants in the approval process so that the
resultant documents reflect their needs and are fit for the intended purpose. If the objective is stated in the document, does it fulfil that objective? If it is stated that the document applies to certain equipment, area or activity, does it cover that equipment, area or activity to the depth expected of such a document? One of the difficulties in soliciting comments to documents is that you will gather comment on what you have written but not on what you have omitted. A useful method is to ensure that the procedures requiring the document specify the acceptance criteria so that the reviewers and approvers can check the document against an agreed standard.

To demonstrate documents have been deemed as adequate prior to issue,
you will need to show that the document has been processed through the
prescribed document approval process. Where there is a review panel, a simple method is to employ a standard comment sheet on which reviewers can indicate their comments or signify that they have no comment. During the drafting process you may undertake several revisions. You may feel it
necessary to retain these in case of dispute later, but you are not required to do so. You also need to show that the current issue has been reviewed so your comment sheets need to indicate document issue status.