Self Improvement

What Every Employee Needs To Know About ISO 9000

By : Harish Yadav	Previous \| Next
Posted on : 16 Jun, 2007	Total Views : 956

Thousands of organisations strive to gain ISO 9000 certification quality system standard. It can improve the way an organization is managed as well as the quality of processes, products and services. There are twenty ISO 9000 Standards. Each standard describes how an area of a company should be documented; the kinds of written policies, procedures and work instructions that should be available to let employees know exactly how to do a good job. Also what types of records need to be kept to show the results of doing the job? This system can lead to better product and service quality since detailed documentation (and good training on how to use the documents), provides a more reliable, consistent method of teaching employees how to do quality work.

The ISO 9000 standard was adopted by the European Economic Community about ten years ago but since has spread to almost 100 countries throughout the world. It is the biggest force in quality assurance today and many customers require this certification since they believe it leads to good business practices, better documentation for traceability, and lower internal costs. For the most part, employees will continue to do their jobs in the same manner as they had in the past. The effectiveness of the ISO 9000 system relies on increased awareness in specific areas of each person�s work routines. The following are some of the main areas every employee needs to be familiar with the company�s Quality Policy statement, the 4 levels of ISO 9000 documentation, what authorizes an employee to do their job and what qualifies them for it.

The 4 Levels of Documentation

ISO 9000 requires 4 levels of documents in every area of the company that effects product, or service quality. All documents must be current and have correct data including titles, numbers, dates, revision letters and authorizing signatures.

Policies Explain WHY things are done the way they are. Managers need to be familiar with them.

Procedures explain WHO does WHAT. This AUTHORISES to do your job so get to know them.

Work Instructions Explain HOW the job must be done.Records to document the result of the job done.

Training and Qualification

ISO 9000 requires everyone who affects product or service quality to be trained. Training QUALIFIES you to do your job. Every person has a TRAINING RECORD. Training must include the following

Basic Things to Know About Your Job:

Where all the paperwork and material comes from before it is routed

What to do with incorrect paperwork, or wrong material.

How to identify, report or segregate defective material.

The following paragraphs are based on many years of experience accumulated by the ACA consulting staff working with dozens of companies nationwide. Experience comes from both large and small companies and covers all types of manufacturing industries, process industries, service companies, local and state agencies, hospitals and universities.

As we provide training to these organisations as well as consulting services, we have learned from people on the shop floor, the administrative support groups, and all levels of management that, although every company has a unique personality and unique competitive advantages, there are common, core fundamental that must be embraced by every employee to ensure the company�s journey to World-Class standing in the marketplace. The ACA consultants specialize in providing these core fundamentals and are pleased to present the following example as a service to the global community via the Internet.

The following paragraphs cover 9 important ISO 9000 issues. These paragraphs are not intended to cover the 20 standards, but will familiarize you with the most important general issues.

QUALITY POLICY

Every ISO 9000 certified company has an established quality policy. You should know and understand it. It incorporates the company�s mission statement and may list specific actions for achieving the mission. You should all be able to state the quality policy in your own words and you should be familiar with the actions that allow a company to achieve the policy.

Procedures and Work Instructions

From a production point of view, you will be doing a few things differently under the new quality system. You will notice that your work processes are now documented in written procedures and written work instructions. Your responsibilities are now defined in the procedures manual that has been developed by the company. Make sure you understand and follow these procedures and make sure they are accurate. From now on, if you want to change the way you do things in your work, you will have to make the appropriate changes in the procedures manual also.

DOCUMENT CONTROL

Under this new quality system, all documents relating to your job will be controlled documents. That means they will be reviewed and approved before issue, and distributed under a formal system of control. You will no longer assume that procedures and work instructions are correct or complete before you use them. Before using any of these documents, you should look at the header information that identifies the document name, document number, revision date, and authorization signature. These must be verified as correct. And finally you will ensure that you have the correct revision of the document either through the �CONTROL COPY� stamp or through reference to the Master Document Index.

CALIBRATION

All instrumentation used to measure critical characteristics of the product must be calibrated. A calibrated instrument is identified by a calibration sticker listing its date of calibration, and the date when that calibration expires. Do not use an instrument to measure any critical product characteristics unless you have assured yourself that the instrument is calibrated. Of course, you have to know which measurements are critical product characteristics.

INTERNAL QUALITY AUDITS:

The ISO 9000 quality system requires an internal audit programme. From time to time, employees from different departments will come to your department and audit the effectiveness of the ISO 9000 system. This is done to ensure that department personnel have received good training, and are complying with the approved procedures and work instructions. When there are problems in a department, it will be audited more often; less problems mean it will be audited less often. Different employees will perform the audits to ensure different viewpoints. The internal auditors have a special training for this job. There are no surprise audits; they will be scheduled in advance. There are three types of things an auditor may find

An OBSERVATION (may be a problem, keep an eye on it but corrective action required.
A MINOR NON-CONFORMANCE (a small problem that needs corrective action)
A MAJOR NON-CONFORMANCE (a large problem that needs corrective action)
There is nothing negative about these audits. They are merely a means of identifying improvements required in the system; they are not set up to identify poor operator performance and names of employees are not recorded, only situations are recorded. Audit reports lead to corrective action that improves company performance. Audit reports also lead to training that may be required to help employees understand how to comply with the procedures and work instructions.

Training

You may be receiving more training than you had in the past, and it will be recorded on a training record. These records will be an assurance that you get full credit for any training you have completed during the course of your work. When an auditor asks how you do a job you should answer that you�ve have been trained to do that job. It may have been formal classroom training, or on-the-job training, or you may have been trained at another company or school before you came to work at your present company. In all cases, your training record list all the various types of training you have had and you should be aware of who has your training record and whether they are keeping it up to date.

Corrective Action

There is an emphasis on corrective action in the new quality system. Whenever one finds a significant problem in the process it is not only corrected but a Corrective Action Request is filled out to document it. These forms will go to the quality systems group where they will be reviewed and analysed for further preventive actions. Everyone should consider a problem in the system to be an opportunity to correct the problem and improve the system.

NONCONFORMING PRODUCT

We should always know when our process or product is within specifications and when it is not. Additionally when the process or product is out of specification it is our responsibility to make every effort to isolate or re-direct the nonconforming product for later processing, and initiate corrective action to bring the process back into specifications. We should additionally recognise the difference between the product or process being out of a defined control range and when it is out of specification.

Quality Records

Throughout the process, there will be records to fill out and file. All required entries on a record form must be completed. If an entry cannot be made because a part of the process was broken or inoperable, then a small note to that effect should be made in the entry block. All record entries must be legible. Data or information that cannot be understood is as bad as putting no data on the form. Care must also be taken to keep it clean, and not ruined by water, grease or dirt. All records are filed when one finishes with them. The fling system is organized to facilitate record retrieval when necessary.

Written By : Harish Yadav

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