The Quality Guru

Welcome to the Quality Guru... This page is devoted to sharing quality ideas, articles, videos, and a forum for open discussion. When there are successes in the organization, noteworthy opportunities for improvement, and near misses that need to be communicated throughout the organization... this is the place to share them. Not only will media from well known quality professionals be included, but articles written by DEL Corporation employees will be shared as well. One of the best ways to improve quality practices is to share information and let the Quality Guru guide you to quality management system enlightenment.

What is a quality management system?

In today's challenging economic climate it is essential that organizations position themselves to provide quality products and services as cost effectively as possible. Organizations that have a system in place to guide the processes from determining customer requirements to making provision for delivery activities to the customer organization. Quality specifications such as ISO 9001:2015 or API Specification Q1 provide a framework for organizations to put a quality management system (QMS) in place.
So... what is a quality management system? A QMS is a strategically planned, formal, and documented system of policies, processes, responsibilities, and procedures focused on meeting customer and regulatory requirements on a consistent basis.

8 Essential elements of an effective qms

1. Quality policy and objectives
A quality policy is a brief statement, approved by top management, that outlines the organization's overall purpose and mission while outlining its strategic direction. It also promotes the company’s commitment to continuous improvement, as well as meeting all applicable regulatory and customer requirements. A quality policy serves as the framework for the entire QMS. Quality objectives are goals set by the organization used to measure how well an organization is performing towards meeting customer requirements. It is up to each organization to determine what functions shall be measured, but ideally they are most closely related to enhancing customer satisfaction. Examples of quality objectives that would give an indication of how well the organization is meeting customer requirements include, but may not be limited to the following: - On time delivery - Number of nonconformances - Zero OSHA recordable incidents - Product performance - Customer satisfaction For each of the areas, the organization must establish attainable goals and link them to established Key Performance Indicators. Key performance Indicators are essential in monitoring the organizations progress, over time, towards meeting established objectives. Quality objectives should be specific, measurable, achievable, relevant, and timely.
2. The Quality Manual
A quality manual is an top level document that describes, in detail, the scope of the organizations QMS. The manual includes specific information about the organization’s direction, objectives, expectations, policies, processes, and procedures. The DEL Corporation Quality Manual is essentially an organization specific translation of the ISO 9001:2015 quality specification. Meaning; ISO 9001:2015 provides a guideline to develop an effective quality management system. The quality manual takes those guidelines and documents how the organization fulfills the requirements. It is essential for the manual to describe the quality management system and not just copy the ISO standard and change a few words. Its important for the manual to provide documentation structure, present a concise overview of the QMS, describes the policy and objectives, and portrays the sequence and interaction of processes.
3. Organizational structure and responsibilities
For the quality management system to operate effectively the roles and responsibilities of the organization's personnel must be clearly defined, necessary resources identified, and the infrastructure required to achieve the organizations quality objectives. The organization uses documents like the organization chart, job descriptions, policies, procedures, and flow charts to meet the requirements of ISO 9001:2015 and the Quality Management System Manual.
4. Data management
Data quality and availability are essential for the success of the quality management system. Data is used to drive continuous improvement of processes, products, and personnel. Without data there is no way to evaluate the effectiveness of the quality management system. Without reliable data the influence on the organization is profound. Inconsistent product quality, inefficient processes, risk to product conformance, product variations, poor customer satisfaction, loss of business, and a significant impact on the cost of doing business are just some of the negative effects to the organization for not compiling proper data. Some of the types of data the organization relies on include: - Customer Satisfaction - Supplier Performance - Product and Process Monitoring - Non-conformance Trends - Preventive and Corrective Actions - Training evaluations
5. Processes
Developing and maintaining a quality management system is a strategic decision made by the organization to establish standardized processes with the goal of achieving repeatable outcomes. This process approach not only considers the outcome, but every process that influences product quality and product delivery. The quality management system ensures that the organization has identified, defined, and developed the necessary process to effectively turn inputs in planned outputs. Developing processes should begin with a high-level, big picture overview of the organization and how the process will benefit the organization. It should also consider the resources the organization has and determine if they are adequate to support the proposed process. While it is important to accurately define the processes required, it is equally important, as with all things quality, to measure the effectiveness of those processes. Key factors in developing quality management system processes: 1. Identify organizational processes 2. Define process standards (what goals need to be met, does the organization have the required resources) 3. Ensure the required data is collected and analyzed to ensure planned arrangements are meeting organizational goals 4. Develop a documented standardized approach to ensure quality outputs 5. Use processes to drive continual improvement
6. Customer perception - Customer Satisfaction
We are in business because of one thing.... our customers. Our primary objective as an organization is to make sure our customers are happy with the products and services we provide. ISO 9001:2015 makes determining customer satisfaction a priority as does our own quality management system. Building a business on one-time customers is extremely difficult. It takes building relationships with our customers, creating a culture that appeals to our customers, and ensuring they become repeat customers and trusted partners. In order to do that the organization must collect customer satisfaction data. DEL Corporation has taken it a step further by examining what our customers think of us as a business partner, not just their satisfaction with our products. It is just as important to understand how our business partners view us as an organization as it is to understand the level of satisfaction they have with our products and services. That's how relationships are built and another way we can measure the effectiveness of the quality management system. The following are just a few ways the organization can collect and analyze perception/satisfaction data: 1. Satisfaction/Perception Surveys 2. Processing all customer complaints through the nonconformance reporting process 3. Analyzing repeat business trends 4. Analyzing quotes that were not awarded 5. Direct customer contact (documented) 6. Direct electronic data (email, text) 7. Pre and Post project meetings 8. Annual management review
7. Continuous Improvement
The certified quality management system maintained by the organization focuses on continual improvement. It is important that the entire organization shares the responsibility for developing opportunities for improvement, but quality documents such as ISO 9001:2015 and API Specification Q1 make it clear that the onus on continual improvement is on top management. Requirement 5.1.1 of ISO 9001:2015 and 4.2.1 of API Specification Q1 outline the need for top management to demonstrate their commitment to the continual improvement of the quality management system. Developing organizational processes that meet quality management system standards for continuous improvement, requires documentation that defines the controls required for continuous improvement. That is why each DEL Corporation quality document contributes to the continual improvement process. It may not be specifically addressed in each document, but they define the controls that will.
8. Control & Management of documents
Control & Management of Documents is arguably the single most important element in any quality management system. It is the quality documents that develop the quality management system. It is the records maintained by the organization that serve as objective evidence. Documents such as the quality manual, quality policy, quality objectives, procedures, etc... that create the foundation the organizations QMS is built upon. Documented information provides records of the effectiveness of the QMS. Most quality management system standards require document control, but do not tell the organization how to do it. They also leave the type of documentation required up the discretion of the organization. DEL Corporation has developed a robust QMS and use an industry standard software solution to maintain it. Within that system (QISS) is a document control module that stores current documents, maintains historical QMS documents, and provides an interface for all employees to retrieve documents as needed. Documents may be paper based or electronic as long as they are available, retrievable, and legible. Any quality management system is only as good as the documents that created it and DEL Corporation has all of the required documents and an outstanding document management system. As the Guru says himself... "If it's not documented... it didn't happen." It is so true of the quality management system. We can say it's effective, but without objective documented evidence there is no way to substantiate that claim.