Developing a Quality Management System
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This document is meant to be neither a substitute for, nor a legal interpretation of, ISO standards. Companies should use this document as a guidance for developing their own Quality Management System and related documentation, including the Quality Manual. All users pursuing certification under a quality standard (e.g. ISO 9001) are strongly advised to refer to the relevant ISO standard and seek professional advice.
Where to Begin
The following guide will help you understand how to construct an effective Quality Management System, which not only earns you a valuable ISO 9001:2008 designation, it can also increase customer satisfaction, revenue and efficiency through careful examination and improvement of every process. While each Quality Management System is highly customized to the characteristics of the company, there are a series of high-level guidelines regarding quality management systems that serve as a starting point:
Step 1: Know the Facts
Supporting your quality management system (QMS) plan with evidence that it will help save your company money is the best way to convince upper management to get on board. Obviously, inefficient processes drive up company costs and unsatisfied customers cost revenue and reputation. Experience across all industries proves the effectiveness of quality management systems on the bottom line.
Step 2: Gather Data
Before you institute a program, research your company culture to identify trends at all levels and from a range of perspectives. Visit worksites and talk to employees to understand how current quality assurance programs—or lack thereof—are functioning. Develop a needs assessment to determine how much work you need to do to shift company culture and practice.
Step 3: Demonstrate a Commitment to the QMS
Make sure all levels of employees recognize the importance of the quality management system and its positive impact on business. Everyone from upper management to hourly employees should understand the goals, purpose and background on the program and should devote continual effort into audits and reviews to ensure its continued effectiveness. There is no use taking large strides to enact a program if management does not support and recognize the need.
These elements form the foundation of support for an effective quality management system. Take plenty of time for these steps before moving on to create and implement it.
Why Introduce a Quality Management System?
Effective and efficient cooperation between customer and supplier is the cornerstone of any quality organization. Holistically and systematically managing processes, including the inputs and outputs of processes as well as their interaction, drives consistent production of quality products and services. A controlled, quality production mechanism detects defective products and services after they have been produced. This system ensures that both customers’ requirements of the organization and the organization’s requirements of the efficient use of available resources are met.
In ISO 9001:2008, the International Organization for Standardization (ISO) defines requirements for quality management systems where an organization:
Needs to demonstrate its ability to consistently provide products that meet customer and applicable statutory and regulatory requirements
Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
Organizations can obtain a certificate of conformity to the ISO standard upon verification of compliance with these requirements by an independent quality system certification body. The certificate can serve as an important business reference between an organization and potential clients, especially when the supplier and client are unfamiliar with each other or are geographically distant.
It will provide consistency and satisfaction in terms of methods, materials, equipment and more involving all activities of the organization, beginning with the customer expectations and ending with their satisfaction. An effective quality management system will help a business to achieve its goals as it does the following:
• Sets direction and meets customer expectation
• Improves process control
• Reduces waste and lowers costs
• Increases market share
• Facilitates training
• Involves staff
• Raises morale
What’s more, the commitment to defect-free products and services that result from a quality management system can serve to reduce your organization’s product liability exposures.
Of course, the creation and implementation of a successful quality management system requires the commitment and contribution of the entire organization to all parts of the process, including the following:
• Thorough documentation
• Continuous improvement
What Makes Up a Quality Management System?
A quality management system is based upon eight basic principles:
1. Customer focus: Careful attention to customer needs and expectations must be incorporated into product requirements.
2. Leadership: A successful quality policy provides unity of purpose and establishes measurable objectives. Leaders should demonstrate their commitment to sustaining and improving the QMS.
3. Involvement: Through adequate training and communication, people must be involved and aware of the importance of meeting customer requirements at all levels of the organization.
4. Process approach: Each process in the organization must transform one or more inputs to create an output of value to the customer. Key business processes may be supported by procedures and work instruction in
those cases where it is judged necessary to rigidly define which rules are to be followed when undertaking a task. Many businesses have core processes that directly add value to the product or service, and supporting processes that are required to maintain the core processes.
5. Systems approach: The relationships between these processes are complex and varied. The way in which they interact must be fully understood and managed to efficiently use available resources and to ensure that the needs of all stakeholders—customers, employees, shareholders and the community—are met.
6. Continual improvement: Constant change in technology and other external factors result in reciprocally changing requirements for customer satisfaction. For this reason, a successful quality management system must never remain static.
7. Factual decision making: In order to adapt and appropriately react to the changing needs of the market, an organization must rely on measurable results. Through regular contact with customers (be it through complaint analysis, opinion surveys or focus groups) and measurement, monitoring and analysis of process and product data.
8. Mutually beneficial supplier relationships: The well- being of the community and the organization depends on its integration into a stable and co-dependent supply chain, which can be regarded as a larger process.
Steps to Creating a Quality Management System
1. Design and build the quality management system. Define and document core processes and well-defined goals and strategies, and determine the needs of one or more stakeholders. Create the structure of the quality management system accordingly. Its design must be led by
senior management to suit the current needs and goals of the organization.
Clearly defined objectives should be documented for each process, and management should name a process owner who will take responsibility for their attainment. An important product of the design process is a written policy detailing all responsibilities and procedures that make part of the quality management system.
2. Deploy the quality management system. Break each core process into sub-processes described by a combination of documentation, education, training, tools, systems and metrics as appropriate to the characteristics of the organization. A common solution to this phase is the use
of electronic deployment via intranet. Components of the deployment phase may include the following:
• Philosophy statements
• Written quality management policy
• Training manuals
• Employee feedback programs
• Training sessions for both employees and process owners
3. Control progress. Regular audits and reviews at the process level are necessary, even when supported by central reviews. Best results are achieved when key stakeholders are documented in the process and when the process owner can control the process. The responsible process owner should be involved in writing procedures.
4. Measure progress to determine the effectiveness and efficiency of each process, and include the contribution of the quality management system to the organization’s established goals. The following components should be measured:
• Policy definition completeness
• Coverage of business
• Reflection of policies
• Staff impressions of QMS on a daily basis
• Speed of change of the QMS
• Relevance of QMS architecture to individual tasks
5. Review effectiveness, efficiency and capability of the quality management system. Communicate to all employees the conclusions reached. Whether or not improvement activities have had the expected effect, this review process must take place.
6. Improve the quality management system. The aim of improvement activities should be to establish internal best practices. It is an integral part of managing change in the organization.
Audits, Reviews and Assessments
In order to maintain, adapt and improve an effective quality management system over time, an organization must carry out periodic and systematic audits and reviews. Audits analyze the effectiveness of the process, while reviews analyze whether the system achieves the required effect using the results of the audit. Both should be conducted according to a regular schedule, although certain processes may require more frequent audits than others.
The aim of an audit is to determine whether processes are effective and whether responsibilities have been assigned correctly – not solely to identify problems. They should be positive, conducted preventively instead of remedially. The emphasis of an audit must never deviate from its ultimate goal of supporting customer satisfaction by improving processes. An audit must be adapted to the process, but general steps include the following:
• Initiation: The scope and frequency of the audit are established
• Preparation: Review documentation of the quality management system (including the Quality Manual)
• Execution: Collect evidence through examination and evaluation, recording observations
• Report: Prepare and distribute findings
• Completion: Retain the report for a future audit of the process
At least annually, the organization should conduct a review of the quality management system. The review should consider the following points:
• Results of audits
• Customer feedback
• Process and product conformity
• Status of preventative and corrective actions
• Follow-up actions from previous management reviews
• Internal or external changes that could affect the QMS
• Recommendations for improvements The review should produce the following:
• Documented improvements to processes or QMS
• Improvements to a product due to customer requirements
• Quantification of resources required to execute improvements
A quality system may be assessed internally, using a first- party assessment; by an external customer against its own or a recognized standard, using a second-party assessment; or by an independent organization, not connected with any contract between the customer and supplier, but acceptable to them both, using an independent third-party assessment.
The certification of conformity to ISO 9001:2008 that is issued after a successful third-party assessment is a way to demonstrate to your customers your commitment to their satisfaction.
Trailer Makers Insurance knows that a successful quality management system can help your organization reach a variety of important goals, including fewer injuries, an improved safety culture and even lowered product liability exposure.
For more information, contact Andrew Dearing, CIC, MWCA, Trailer and Truck Body Industry Risk and Insurance Advisor at Trailer Makers Insurance by calling (478) 397-6086 or emailing email@example.com.