QUALITY SYSTEMS

1. QUALITY SYSTEMS THE CHOICE IS NOT ALWAYS CLEAR By Dan and JoCeal Urbaniak Email: wqn@wqntoday.com (866) WQN-TODAY

2. CHOOSING A STANDARD • Know your options (ISO 9001:2000, AS9100,…) • Ask your customer what they require or expect. (If you have received a generic supplier letter and it does not fit your business, you need to call your customer). • Understand what regulatory requirements you should adhere to (especially if you are shipping out of the country). • Look at what your competitors are doing. • Take into consideration the customer base, potential customers, what percent of your market is asking for a specific standard, etc. • Where are you in the “supplier chain”? Are you first tier, second, third - and where do you want to be? • Consider starting out with the shell of ISO 9001:2000 and add the more stringent requirements as contractually agreed upon.

3. INTERPRETING THE STANDARD • Purchase and read your chosen standard and read it until it is clear. Start at the beginning as there is a lot of informative and important information. • Spend the money up front on your development documentation, such as companion resources on auditing, vocabulary or principles that are referenced throughout the standard. They clear up a lot of gray matter. • Make a copy and start highlighting key points such as; application, shall’s, significant notes, documented procedure, top management, records required, etc. Know and understand your options, such as documented evidence vs. methodologies or processes. • Do not read into the standard as there is really no hidden agenda. Take it for what it is because there are many ways to “skin the cat”. (i.e. 7.4.2 “purchasing information” shall describe…., notice it does not say the “purchase order” shall describe).

4. INTERPRETING (continued) • Roundtable your group and learn the standard together. This way you have an assortment of options and interpretations throughout the different departments. This has been very helpful for organizations. • If the standard is new to your group, start a matrix with columns that indicate the criteria, such as records, procedure, plan, top management, employees who will be responsible for that area, etc. • Most organizations are surprised to see that what they are doing already meets the requirement simply because they really don’t understand the verbiage, or they thought their way was not formal enough. • Read the requirement. Think about how you may be meeting it now, and go with it. ISO is a system that is meant to continually improve as you evolve.

5. TAKING EXCLUSION • Section 1.2, Applications - describes the fact that exclusions are limited to the requirements within clause 7, Product Realization. Your job is to make sure the exclusion does not affect the organizations ability, or responsibility to provide product that meets customer and applicable regulatory requirements. • In other words, do not take exclusion because you choose not to control that area (such as calibration) if indeed you have measuring devices. • Your job is to take exclusion because “the organization does not have”, “does not require”, “it is not applicable”, or “it is not within the scope” of clause 7.3, 7.5.5, etc. • These are acceptable reasons for taking exclusion.

6. DEVELOP AND IMPLEMENT • Now that you have a plan of action, and a list of documentation and records, it’s time to get down to business. • Believe it or not there is a guideline for everything. In the back of the standards there is a Bibliography with a list of guidance tools, such as ISO 10013 - Guidelines for Developing Quality Manuals. • Go directly to the source when gathering information on a specific area like purchasing. Ask department personnel if they have any existing documentation, what their procedures are, and can they give you a rough draft of what they do everyday. This is the easiest way to clearly and concisely develop procedures. • Once you have gathered all of the information, review against the standard, add in any missing requirement's, formalize and go back and sit with the group until everyone is satisfied.

7. DEVELOP AND IMPLEMENT (cont) • As you start developing your documentation, don’t be afraid to get creative by putting procedures in some places, and flowcharts in simple places such as “customer property”, if it is minimal. Flowcharts make great procedures if they are prepared properly. • Once all areas of the standard have been addressed and developed, get your approvals from the approving authorities. You will need to show proof and maintain these records. • Determine and set up the document control system with restrictions. Is it electronic-password protected? Hard-copy requestors need to go to one or two designated people for latest revision, master-lists posted, etc. • This is the key to the entire controlled documentation.

8. INTRODUCE/TRAIN • Since training is part of ISO and records are required, set up a training schedule by clause, department and time. Have personnel sign in so training records can be updated or developed. • Start with the Quality Manual (QM) or level 1, and include every employee within the company, subcontracted employees, satellite sales people and any other person associated with your organization that needs to understand your QMS (quality management system). • The purpose of QM training is to introduce the QMS in its entirety -the quality policy, and the employees responsible for specific areas. This typically takes about an hour. • As you hire new personnel, this is where you want to start their training program.

9. INTRODUCE/TRAIN (continued) • The most important point you need to make to every employee when you train them is the fact that there is a formalized quality management system in place, and… • Top management is committed to the future of the company, providing the necessary resources, customer satisfaction, employee empowerment, continually improving processes and ensuring quality objectives are communicated and established. • They also need to understand that now that there is a system in place. You cannot change documents, develop your own within your department, or red line without going through the procedure that represents the change, or now, change request.

10. HOW DOES THE QMS AFFECT ME • You are the expert in your area 8 hours per day, so your voice will be heard the loudest when it comes to making management aware of any changes that you see, or feel, are necessary (i.e., the work instruction you have been given is not written the way you are performing the task), any resources that are necessary (new equipment, equipment that needs to be replaced, broken equipment, etc). • You also need to be aware of who to go to when a situation arises such as, a discrepancy, out of date measuring device on the floor, form, or work instruction identified on a shop order, etc. • Management cannot be everywhere all day long, so they rely on employees to keep them informed of what goes on in their areas. They do not want to find out when customers or auditors come into the organization.

11. HOW DOES THE QMS (cont) • Employees hired in for specific areas are trained to level 2 or the procedures and lower level documentation (level 3) like work instructions, forms, etc., which should be referenced in the procedures. • What every employee needs to really understand is that a standard really is not meant to completely change working areas unless there is a great need for it (determined by discrepancies, poor productivity, inconsistent output, etc). This is left up to the employees to be honest about what goes on in their areas and members of management, the employees, and quality to determine what type of changes are necessary. • Formalizing a system brings uniformity, historical or objective evidence, consistent training results and continual improvement.

12. HOW DOES THE QMS (cont) • Remember, when there is a problem in an area, it is not looked at the employees fault. Even if it is lack of training, it is looked at as a system breakdown or lack of commitment from management. • The key to the entire Quality Management System is the ISO Representative. This person must have some of the following: the right attitude, tenacity, the drive to succeed, be very organized, able to multi-task, report to management, able to report good and bad news, stay on schedule, keep employees and customers informed, keep updated, remain excited, remain level headed, continually educated and really take pride and care about the other employees and the job they do!

13. WHY COMPANY’S FAIL • Lack of support from upper management, which seems to be understood and felt throughout the organization. • Choosing the wrong person to drive the system. • Purchasing a template and not customizing it to fit the organization’s business. • Becoming too lax on the maintenance of the system. • Not conducting mandatory requirements, such as internal auditing at planned intervals, management reviews as planned, not training personnel (new or cross training), not implementing procedures or forms, using forms that are not controlled, etc.