CORPORATE ATTRIBUTES OF IS09000 AND THE QUALITY SYSTEM Bob Anderson Western Regional Manager Fremont Industries Shakopee, Minnesota Presented at: FINISHING '95 CONFERENCE AND EXPOSITION September 18-21, 1995 Cincinnati, Ohio
1 CORPORATE ATTRIBUTES OF IS0 9001 AND THE OUALITY SYSTEM INTRODUCTION As companies look ahead to a global marketing future, the IS0 9000 set of standards is gaining wide spread acceptance as a vehicle towards promoting a uniform quality system. With the attention US goods have received in the past few years, improved quality to compete with foreign and domestic competition will become a vital part of any company s decision to obtain IS0 certification. Instituting a quality system (quality policy) around the framework of the IS0 standards will be a powerful tool in gaining both a quality reputation and acceptance in these marketplaces. There are four (4) IS0 classifications to which a company can seek certification. These are summarized below with a brief explanation given for each level. It should be noted, that a company with multiple plant locations needs to certify & location and that the certification is not an all encompassing endorsement for all plants. IS0 9004 Require Quality Management and Quality System elements are in place and are used as guidelines within that company. In other words, the company has an organization chart and has a written mission statement. 1
2 IS0 9003 In addition to the requirements of IS0 9004, the company has Quality Assurance in final inspection and test. This provides the end-user with the confidence that before a product is shipped, some inspection process has occurred to deem the contents of the shipment are correct. IS0 9002 In addition to fulfilling the certification requirements of both IS0 9004 and IS0 9003, a Quality Assurance program is in place during the manufacturing of the product. This often will require that the company can demonstrate to the end-user that where possible, they are purchasing materials used in manufacturing this product, from an IS0 certified company. The other very important item with a company certified to IS0 9002 is their ability to show an agseed to level of service with each customer they have. This often requires a signed agreement between the supplier and their customers for after sale servicing requirements. IS0 9001 Once again, to be certified to this level, all of the above criteria have to have been met plus, the company must demonstrate Quality Assurance in the design and development of its products. The protocol here is stringent and the issues of conformity versus a nonconforming situation takes precedence. Validation is the operative word that ensures that new products developed must be tracked for a period of twelve months to all customers purchasing this (these) product(s) to ensure they continue to meet the expectation needs of these customers. The important vehicles from a customer (end-user) perspective lies in both the certification levels of IS0 9002 and IS0 9001 in that definite operating procedures must be in place that reauires a written response from your company in the event of a customer s dissatisfaction regarding product or service. Once a company has determined that they want to seek certification to some level of the IS0 standard and they have hired a qualified consultant to lead them through this process, they begin by talking to a wide cross section of their existing customer base. This QFD (Quality Functional Deployment) process includes developing a matrix based on the answers provided to questions asked of these customers. It provides an in-depth look at what you do well as a company, what you need to improve upon and y& customers reallv want or value. You may believe that you know what is wanted and valued by the customer, but their expectations are or may be completely different. 2
This same matrix is developed as a result of the feedback you get from your internal customers,... Your employees. Both of these surveys are real eye openers for most companies undertaking IS0 certification. Dependent on your company s products manufactured, most customers are interested in what your plans are for the future. Does your company reinvest into a solid research and development program that addresses the future needs of its customers. This is a key determination and does often distinguish between having met the criteria of customer satisfaction versus the criteria needed in having a very satisfied customer. Two distinctively different levels of customer awareness. ATTRIBUTES OF IS0 9001 AND THE OUALITY SYSTEM There are four distinct levels in the Quality System Documentation Pyramid that detail how through your Quality System, the expectation levels your customers expect are achieved. They are: Quality Manual and Other Manuals (Sales Manual) Quality Assurance Procedures. Operating Procedures Work Instructions Forms and Records Production Worksheets Inspection Instructions Test Procedures Written Documents Let s now look at each of these pyramid sections and list some of the attributes which IS0 900 I affords your customers and its effect on quality.
- Policv The Quality Policy or Quality Manual is a controlled document following the rules outlined under the International Standard IS0 9001, Secmd edition, 1994-07-01. There are twenty (20) sections that provide the model for quality which if your company is certified, must detail and reference operating procedures that ensure that quality is not adversely affected. Procedures Operating procedures provide the written documentation of a sequence of events necessary to accomplish a given task, so that quality is not jeopardized. These procedures are referenced within each section of the Quality Manual and there may be more than one operating procedure per section dependent on the scope of that section. It is these operating procedures that really give attribute to doing business with an IS0 9001 company because it addresses the following areas that have direct impact on how gualitv could be affected if there is a deviation from the procedure. Feature Batch to batch uniformity of the product manufactured. On time deliveries Contract Review Benefit Consistent Quality today - next year Lower to no inventory levels required No wrong products or incorrect amounts are ever received and are shipped on precise agreed to dates. Design Control Document Control, Purchasing and Supplier Verification, Process Control, Inspection and Testing. Provide the tools necessary to continually audit the Quality System and provides the mechanism towards continuous process improvement through research and development. These five (5) operating procedures all assure the customer of product uniformity whenever that product is ordered and that it is shipped only after passing a number of stringent internal audits. = QUALITY! 4
5 ATTRIBUTES OF IS0 9001 AND THE QUALITY SYSTEM Feature Control of Nonconforming product. Corrective and Preventative Action (Extremely Valuable) Training Servicing Benefit This operating procedure details the steps necessary to assure that products identified with manufacturing flaws are taken out of the distribution network and isolated. Perhaps the heart and soul of the Quality Policy, it identifies and provides root cause solutions to deficiencies in the system. It to, via the Customer Complaint Procedure, provides an avenue for your customers to verbalize their frustrations with a product, process or servicing issue. Continually assesses the training requirements and needs of those individuals representing your company in the field. This detailed procedure provides the mechanism of assuring the correct use of the product by the customer. This too provides the criteria of the frequency and level of service that your company and the customer agree to in writing. Work Instructions No operating procedure can detail all of the steps necessary to fulfill a given task nor is it the intent of the operating procedure to do so. Rather, the avenue to complete this task is through written work instructions to be used by the department in need. The following departments will usually have detailed work instructions: Production Worksheets Inspection Instructions Order Processing Custom Contracts Approved Shippers List Approved Venders Testing Procedures Customer Service Reports and Customer Service Verification Agreements 5
6 ATTRDBUTES OF IS0 9001 AND THE OUALITY SYSTEM Forms and Records Material Review Reports, Validation Reports, Inspection Reports, Field Service Reports, Training Records, Test Data Records, Equipment Calibration Logs, Audit Reports, etc. These are some of the records that provide written documentation of events that have occurred. The single most important thing to remember is that a form is a document that has not been filled out while a record is a form that has been completed. Why is this an attribute of IS0 9001 and the Quality System. Because if your customers every conduct an audit of your company (and they will) this is an area that is heavily audited and it too provides an immediate alert to a process that is not in control. Should this occur, then it is always best to identify the root cause of a problem to eliminate a reoccurrence of this nature in the future. Oualitv Imorovement Stow Your ability to define the root cause to a problem and not a lot of symptoms that together cause a problem to occur should always be in place both at your workplace and as importantly, at your customers work place. The natural progression through this process does not allow you to discuss any future plans without identifying the root cause solution to the problem at hand. There are seven (7) steps in this process: 1. 2. 3. 4. 5. 6. 7. Define the purpose or objective Measure the current situation compared to the objective Analysis of the problem (Fishbone diagrams or flowcharting) Provide solutions to the problem Check the results obtained. Did it meet the objective stated? Develop a standard operating procedure Future plans. Considering what is learned, are any other steps needed or customers who should be notified. This process is also referred to as the Deming Circle with four (4) sections: 1. Plan - steps 1-3 2. Do- step 4 3. Check - step 5 4. Act - steps 6 and 7 ACT PLAN CHECK DO
7 ATTRIBUTES OF IS0 9001 AND THE OUALITY SYSTEM The Quality Improvement Story is a natural with an IS0 9001 Company and as natural as this process is, a further enhancement is provided the customer by those IS0 9001 companies who also implement and practice the concepts of Total Quality Management or TQM. Total Oualitv Management A common mistake made by many firms is to have a Quality System based on TQM. A more natural progression is to first define and certify under IS0 9001 and then implement TQM into the quality system or, you will find yourselves rewriting most of the operating procedures and work instructions. What TQM does for a customer is to develop internal processes as well as external processes designed at continuous urocess improvements and utilizes many other Statistical Process Control measures towards further improving Oualitv. Statistical Process Control (SPC) Placed into a very simplistic statement, SPC identifies critical trends in a process. It is well understood that inspection cost s money and 100% inspection costs even more money. Using the concepts of SPC, it can be mathematically determined or predicted when a process may reach an out of control condition. IS0 Supplier Aliqment An obvious benefit to a customer is to align themselves with as many IS0 9001 suppliers as possible and to do this as early in the decision making process as possible. But why is this alignment so beneficial to a customer? Because all IS0 9001 suppliers are governed by the same set of hndamental rules. Rules that always point in a common direction and that is, performing: a given task without sacrificing Oualitv. Speaking again of quality, it is paramount to understand that with an IS0 9001 company, everyone in that organization is responsible for quality that leads to a natural progression with your customers. Having all suppliers certified to IS0 9001 creates a unique and very successful partnership with these customers. Customers who have a common goal of maximizing productivity while minimizing or eliminating the possibility of rejects. Let s look next at some of the elements of successful partnering. 7
ATTRIBUTES OF IS0 9001 AND THE QUALITY SYSTEM Elements Of Successful Partnerinq A fundamental list of the elements that promote successful partnering could probably be debated forever however, there are perhaps five (5) key elements that apply regardless of the business your company is in. They are: 1. Commitment 2. Closely Aligned Philosophy 3. Mutually Beneficial 4. Excellent Lines Of Communication 5. Trust Understanding what is meant with each of these elements will provide further, the importance of doing business with an IS0 9001 Certified supplier. It in fact does show, that you will come full circle back into the quality system and the obvious benefits of the IS0 process. Commitment - There are three (3) key sub-categories related back to the IS0 9001 Quality Manual and the Operating Procedures therein: 1. Signed Customer Service Agreements - These provide a mechanism for tracking promises made to the customer. 2. Batch to Batch Product Conformity - Discussed earlier, this simply lessens the occurrence of product deficiencies and hence potential production problems. -3 3. On-going Training For Management and Line Staff - Just as the Quality System provides for continual training of an IS0 9001 company s employees in the field, that training is extended to key people at the customers location on a frequent, on-going basis. Closelv Aligned Philosouhv - Again, three (3) primary focus points: 1. Promote Continuous Improvement Projects or Processes - while not related directly to product changes in a process, this brings in an opportunity to keep a customer abreast of new technology in his industry 2. Promote An Environment Of Opportunity To Our Employees - Strange but true, just as your company present opportunities for your employees (both personally and professionally), your customers are doing the same with the underlying theme that longevity is a key element in our mutual S
9 ATTRIBUTES OF IS0 9001 AND THE OUALITY SYSTEM Elements Of Successful Partnering 2. long term success. It too is a topic that most customers or potential customers will ask of you during an internal audit of your quality system. 3. Define Quality As A Never Ending Cycle Of Opportunity - Through effective an open partnering, quality improvement is always at the forefront of discussions. Mutuallv Beneficial - Certainly suppliers and customers alike want to be associated with leaders and innovators in their industries. Mutually aligned philosophies help assure the successes of both concerns. There a four (4) primary areas: 1. Extension Of Your Engineering Staff - Everyone needs to be in the loop of changes in any process. 2. Promote Cost Product Improvement Projects - Always be looking to see if your product can be used more efficiently and if possible, in other areas within the manufacturing complex. 3. Vendor Who Will Be Around For Many Years - Change for the sake of change is never good and companies want to do business with successful vendors. Just as vendors want to do business with companies who are stab le. 4. Vendor Who Has Multiple Product Lines - Obviously in today s marketplace, it is good business practice to source a common vendor into as many areas as possible in a plant. Usually will promote better communication and certainly promotes economic value as well. Excellent Lines Of Communication - This is a fundamental concept that is all to often taken for granted and when those lines of communication break down, there are no winners. Only Losers! Effective and open communication must exist between: 1. Line support and engineering staff members 2. Powder Application and Equipment Vendors - Again, networking with vendors who have IS0 900 1 Certification always promotes efficiency. (This is the washer, oven and powder delivery systems companies.) 3. Powder Coating Vendor(s) - The relationship with this company and your pretreatment supplier absolutely must be established and on-going. 9
I 10 ATTRIBUTES OF IS0 9001 AND THE QUALITY SYSTEM Elements Of Successful Partnering - Communication 4. Written and Signed Customer Service Reports - This is a very effective tool to use to keep everyone in the necessary communication loop aware of what is happening with their finishing process. Add to this an Operations Manual designed to not allow potential defects from entering or progressing through the production process and you can greatly reduce the number of rejects or rework potentials. Trust - Last but certainly not least, is the element of trust in a successful partnership with a customer. Two Areas: Summarv 1. Mutual Confidence Towards Non-Disclosure Principles - This promotes an ethical responsibility between you and the customer in that processes in use are confidential between each other. 2. Firm Reliance Towards Our Mutual Goals - In the onset, it should be a prerequisite as to what are the outcomes expected from the process or processes involved. Then, an agreed to schedule needs to be established to review these goals to assure thev are being; met and or to modify them to another level of expectancy. It is true that in working with a vendor certified to IS0 9001:1994 (E) standards and as importantly, working as a team to partner with other IS0 vendors in a finishing process, everyone comes out a winner. While other vendors are simply addressing the issue of Customer Satisfaction you now have elevated your company s position by working with vendor s with Corporate Attributes of IS0 9001 and with a Oualitv System in place that addresses the needs of A Totally Satisfied Customer. Bibliowaohv International Standard IS0 900 1, Second Edition, 1994-07-0 1 (E) 10