The 9000 Resource

Do we need to control our forms?

One of our frequently answered questions has to do with the control of Forms. Why do forms have to be controlled, and how in the world can we control them all?

Well, forms are designed to make sure that you collect the data that is required. Forms often are also acting as work instructions, indicating steps and order of steps for a process, telling what data to collect and specifying the acceptable limits for that data. If a change is made, it is important to get that change out to everyone using the form.

But how can an organization control the forms, and still make them available to everyone who needs to use them?

Assign individual numbers and revisions to the forms and list them on the master list on their own worksheet or page. Keep a record of approval, either on the original copy of the form or on an approval list. All of this can be handled the same or very similar to your other documents.

But then forms will be printed in large quantities and distributed to the point of use or points of use. That is where you will need to take a look at specific measures to control the forms themselves. Indicate on the master list where the blank forms are distributed so that when a revision is made the old version can be collected and destroyed. Many companies have a designated area in each department where blank forms are kept, minimizing the number of distribution places for forms.

Forms play an important role in controlling processes and in collecting data for analysis and for records. For more detail on controlling your forms check the “Document Control Procedure” available from the The 9000 Store.

For prepared forms for ISO 9001:2000 procedures check out the documentation package. The9000Store is there to help make your project efficient and effective! Make use of those professional tools, save time and resources, and design a great system.

Facing the Challenge of Documenting your ISO System

There are several challenges your organization will face as you start to document procedures and work instructions. According to feedback, the two hardest things for employees involved in documenting the procedures has been:

1. Starting with a blank page
2. Making the different QMS Procedures work together

How can you help employees with these challenges? There are several options to helping employees produce good documentation.

Technical Writing Services

Many technical writers and technical writing firms specialize in ISO 9000 documentation. This approach is often used in large companies, with large amounts of documentation to prepare. A common approach taken is to have the tech writer interview people responsible for the process, and document the process. This approach must be combined with incorporating any changes to the process that are being made to comply with ISO 9000:2000. Involving the tech writer in meetings as you plan the changes will help with coordinating the changes and the documentation.

Benefits of this approach can be:

Clear, concise documentation with a professional look

Good coordination of documentation if the writer is involved in the project meetings.

Drawbacks can include:

Cost

Lack of a feeling of ownership for the documentation from the employees

Prepared Templates or Documents

Templates prepared by your organization or an outside organization can be very helpful to employees.

To prepare your own templates, develop a standard format that you want to use for procedures and a format for work instructions. You may also want to write a work instruction for "Writing a Procedure" and "Writing a Work Instruction". Useful items to include are:

Definitions for common items such as Records, Forms and Attachments.

Definitions for Procedures and Work Instructions

General writing guidelines. For example, "Start sentences with an action word", "Include the job title of the person responsible for the action "

Providing clear definitions will help employees create documents that are consistent with other employees' documents and prevent the need for a lot of editing towards the end of your project.

Using a prepared Documentation System can save a tremendous amount of time and effort if it is well prepared. The 9000 Store has a complete documentation system available. It has been prepared by ISO 9000 Professionals (registered Lead Assessors) that provide the information for our site, and answer your technical questions. If you are familiar with the quality of information on our site, you can be confident in the Documentation System that they provide. The 9000 Store also offers a satisfaction guarantee on their products. We have based the following information on that system.

To use a Prepared set of Procedures and Related Quality Manual and Forms:

Purchase a system from a reliable source that will provide professionals to answer your questions as you use their product.
(The system referenced here is available at www.the9000store.com)

Give each procedure to the team or individual responsible for that section of the standard.

Have the team or individual review the procedure and compare it to the Task List.

The procedure documents how the requirements can be met. Evaluate this approach to determine if any changes need to be made to the documented process to make it work for your organization.

Determine what changes need to be made to your organizations practices to meet the requirements.

Edit the documentation as needed, and train employees on changes to previous processes or practices.

Implement the new procedure, collect records on the forms provided.
Ask questions along the way from the Documentation System supplier.

Benefits:

Procedures and Quality Manual have been designed to work together to address the requirements of the ISO 9001:2000 requirements. This saves time and effort in determining what procedures to have for your QMS, designing the QMS system, coordinating the procedures, determining how to address the requirements and document the procedures.

Technical support is available for your questions.

Documentation is professional in presentation.

Employees do not have to face a blank page to fill.