An employees guide to ISO 9002
ISO 9002 can improve the way an organization is managed and can improve the quality of processes, products and services. There are twenty basic requirements to ISO 9002. Each requirement 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.
- What types of records need to be kept to show the results of doing the job
ISO 9002 can lead to higher product and service quality because clear documentation (and good training on how to use it), provides a reliable and consistent method of teaching employees how to do quality work.
The alternative methods of training and communication usually lead to mistakes, scrap and rework; drive internal costs up, increase lead times and cause frustration due to poor documentation, poor training, and poor communication.
The ISO 9000 standard was adapted by ISO from a previous British Standard (BS 5750) and has spread to almost 100 countries throughout the world. It is the biggest force in quality assurance today and many customers require this certification because they believe it leads to good business practices, better documentation for traceability, and lower internal costs.
Employees will generally be performing their jobs in the same manner as in the past, but the effectiveness of ISO 9000 system relies on increased awareness in some specific areas of each person's work routines.
Following are some of the main areas every person needs to be very familiar with concerning the company's Quality Policy Statement, the levels of ISO 9000 documentation, what authorizes an employee to do their job and what qualifies an employee to do their job.
ISO 9000 requires 4 levels of documents throughout every area of the company that affects product, or service quality. All documents must be current and have correct data including: titles, numbers, dates, revision letters, and authorizing signatures.
Every ISO 9000 certified company has an established quality policy. You should know it and understand it. It includes the company's mission statement and may list specific actions for achieving that mission. You should all be able to state that quality policy in your own words and you should be familiar with the actions that allow a company to achieve that policy.
From a production point of view, employees will be doing a few things differently under the new quality system. They will notice that the work processes are now documented in written procedures and written work instructions. Employees responsibilities are now defined in the procedures manual that has been developed by the company. Make sure that they understand and follow these procedures and make sure they are accurate. From now on, if an employee wants to change the way they do things in their work, the appropriate changes will have to be made in the procedures manual.
ISO 9000 requires that everyone who affects product or service quality has been trained.
Training QUALIFIES an employee to do their job. Every person has a TRAINING RECORD and should know where it is
Training includes the following job basics:
- Basic things to know about the job.
- Where all paperwork and material comes from before it gets to them.
- What to do with incorrect paperwork, or wrong material.
- How to identify, report, and segregate defective material.
- Where all paperwork and material goes when you are finished with it.
Under the new quality system, all documents relating to a job will be controlled documents. That means they will be reviewed and approved before issue, and distributed under a formal system of control. Employees will no longer assume that procedures and work instructions are correct or complete before they use them. Before using any of these documents, they should look at the information that identifies the document name, document number, revision date, and authorization signature. These must all be verified as correct. They can make sure they have the complete document through the page control numbers. And finally, they will ensure that they have the correct revision of the document either through the "CONTROL COPY" stamp or through reference to the Master Document Index.
All instrumentation used to measure critical characteristics of the product must be calibrated. A calibrated instrument is identified by a calibration sticker. Do not use an instrument to measure any critical product characteristics the instrument is calibrated.
The ISO 9000 quality system requires an internal audit program. From time to time, employees from different departments will come through every 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 had special training for this job. There are no surprise audits; they will be scheduled in advance. There are 3 types of things an auditor may find
1) An "OBSERVATION" (may be a problem but not sure, keep an eye on it, no action needed)
2) A "MINOR NON-CONFORMANCE (a small problem that needs corrective action)
3). A MAJOR NON-CONFORMANCE (a large problem that needs corrective action immediately)
There is nothing negative about these audits. They are merely a means of identifying needed improvements 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 the company. Audit reports also lead to training that may be required to help employees understand how to comply with the procedures and work instructions.
There is an emphasis on corrective action in the new quality system. Whenever the company finds a significant problem in the process, it will not only be corrected but Corrective Action Request will be filled out to document it. These forms will go to the Quality Assurance Representative (QMR) 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 that problem and improve the system.
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.
Throughout the process, there will be records to fill out and file. All required entries on a record form must be completed. 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 that records are kept clean, and not ruined by water, grease, or dirt. All records are filed when you finish with them.
Employees may be receiving more training than in the past, and it will be recorded on a training record for each employee. These records will be their assurance that they get full credit for any training they have completed during the course of their work. When an auditor asks how they know how to do their job, they should answer that they've been trained to do that job. It may have been formal classroom training, or on-the-job training, or they may have been trained at another company or school before they came to work at the present company. In all cases, their training record list all the various types of training they have had and employees should be aware of who has their training record and that they are keeping it up to date.
Last edited: 11/03/10
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