"What Every Employee Needs To Know About ISO 9000"

by Gene Oster, CPIM

Thousands of organizations are working to be certified in the ISO 9000 quality system standard. This can improve the way an organization is managed and can improve 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 exactely 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 higher product and service quality since well written documentation (and good training on how to use the documents), provides a more reliable, consistent method of teaching employees how to do quality work than any of the following ways of telling employees what is expected on their jobs:

1. A brief orientation by the HR Department, followed by some well-meaning verbal instructions from the Department Supervisor;

2 "Read these old, out-of-date procedures and then do-the-best-you-can;"

3. "Don’t worry about a thing, someone-out-there will show you what goes on around here."

These methods 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 adopted by the European Economic Community about ten years ago and has spread to almost 100 countries throughout the world. It is the biggest force in quality assurance today and many of 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 be performing their jobs in the same manner as in the past. But effectiveness of the 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 4 levels of ISO 9000 documentation, what authorizes an employee to do their job and what qualifies an employee to do their job.

The 4 Levels of Documentation

ISO 9000 requires 4 levels of documents throughout 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 we do things. Managers need to be familiar with these.

Procedures Explain WHO does WHAT. They AUTHORIZE you to do your job; know them.

Work Instructions Explain HOW to do your job.

Records Needed to document the results of the job that was done.

Training and Qualification

ISO 9000 requires that everyone who effects product or service quality has been trained.

Training QUALIFIES you to do your job. Every person has a TRAINING RECORD and knows where it is

Training must include the following job basics:

Basic Things To Know About Your Job:

Where all paperwork and material comes from before it gets to you.

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.

The following paragraphs are based on many years of experience accumulated by the aca consulting staff working with dozens of companies nationwide. Our 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 organizations, 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 fundamentals 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 our global community via the internet. We welcome your feedback concerning this material; please feel free to contact us via e-mail listed on our home page, www.theacagroup.com

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 it and understand it. It incorporates 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.

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 all be verified as correct. You can make sure you have the complete document through the page control numbers. 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 program. From time to time, employees from different departments will come through 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 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)

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 our company. 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 have in the past, and it will be recorded on a training record. These records will be your assurance that you get full credit for any training you have completed during the course of your work. When an auditor asks how you know how to do your job, you should answer that you've 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 you 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 that they are keeping it up to date.

Corrective Action:

There is an emphasis on corrective action in the new quality system. Whenever we find a significant problem in the process, we will not only correct it, we will fill out a Corrective Action Request to document it. These forms will go to the quality systems group where they will be reviewed and analyzed for further preventive actions. Everyone should consider a problem in the system to be an opportunity to correct that 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 recognize 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 block does not apply for the particular situation, then a line should be drawn through that block to indicate that it was not filled in on purpose (and not just a forgotten entry). 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 that records are kept clean, and not ruined by water, grease, or dirt. All records are filed when you finish with them. The filing system is organized to facilitate record retrieval when necessary.

[Ellen Kane, CPIM] [James Tarr, CPIM] [Doug Howardell, CPIM]
[Gene Oster, CPIM] [Ray Blinde, CPIM] [Steve Davis, CPIM]
[Norm Raffish, CPIM] [Bob Gilson, CFPIM, CIRM, CMC]

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