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Our newsletters provide guidance on ISO 9001, AS9100, ISO 13485, ISO/TS 16949, TL 9000, ISO 14001, ISO 27001, ISO 20000, ISO 22000, and related ISO standards, as well as, Six Sigma.
If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know.
ISO 9001:2000, Clause 7.1 and Quality Plans
The words "plan", "planned", and "planning" are used more than 30 times in the requirement clauses of the ISO 9001:2000 standard. A plan is simply a method you develop before doing something so you are more likely to have a successful result.
The term "quality plan" is only used once in the standard, in a Note associated with clause 7.1, Planning of Product Realization. The Note refers to a quality plan as a document specifying the processes of the quality management system, as well as, the resources to be applied for a specific product, project, or contract.
According to ISO 10005:2005, quality plans provide a means of relating specific requirements of the process, product, project, or contract to work methods and practices that support product realization. The benefits of establishing a quality plan include:
1. Increased confidence that requirements will be met
2. Greater assurance that processes are in control
3. Motivation it can give to those involved
4. Insight into opportunities for improvement
Development of a Quality Plan
Your organization should identify the need for a quality plan. For example, a quality plan may be needed for legal or customer reasons, to organize and manage activities, optimize the use of resources, to monitor or assess compliance, or minimize the risk of not meeting requirements.
However, in some cases, an organization with a well established system may be able to meet its needs for quality planning without developing separate quality plans.
After deciding to create a quality plan, it is time to identify its inputs. For example, what are the requirements for the plan, the needs of the people that will use it, the resource requirements, and any risk assessments.
You must determine what is to be covered by the quality plan and what will be addressed by other documents. The scope of the plan will depend on the extent the plan will be supported by a documented quality management system, as well as, the processes and quality characteristics that are unique to the product, project, or contract being addressed.
You will need to name someone as the author of the document and responsible for its preparation. Of course, multiple people may be involved in contributing to its content.
Content of a Quality Plan
The quality plan should indicate how the required activities will be carried out, either by including that information, or referring to other documents, for example, documented procedure, project plan, work instruction, checklist, or computer application.
A quality plan may include the topics listed below or refer to their coverage in other documents:
Scope, purpose, and expected outcome
Inputs and reference documents
Quality objectives and customer satisfaction issues
Management responsibilities for activities
Document and record controls
Resources for successful execution
Infrastructure and work environment
Requirements to be met for product, project, or contract
Customer communication and records
Plan for design and development
Purchasing requirements, methods, and controls
Production and service inputs, activities, and outputs
Methods for identification and traceability
Customer property identification and control
Product preservation and delivery
Nonconformity control and limits on rework and repair
Monitoring and measurement to obtain evidence of conformity
Audits to monitor conformity and effectiveness
The quality plan may be in presented in one of several different structures. For example, it could be a simple text description, a table, a document matrix, a process map, or a work flow. ISO 10005:2005, Guidelines for Quality Plans, includes examples of quality plans in its Annex A.
ISO 10005:2005 can be ordered at this ASQ Web Page.
Operational Excellence Online LIVE!
Industry Week is hosting a free 12-session, 2-day online conference on Wednesday, October 10 and Thursday, October 11. The one-hour sessions start at 11:00 AM EDT and complete by 5:00 PM EDT each day.
The sessions on October 10 are:
Manufacturing Execution: Best Practices for Streamlining Global Operations
Improving Operational Availability to Achieve Lean Manufacturing Goals
The Benefits of Wireless Technology for the Factory Floor
Enabling Lean Success through Leadership and Culture
From Plant Floor to Corner Office: Facilitating Seamless Communication
Achieving Process Manufacturing Excellence
The sessions on October 11 are:
Integral Digital Manufacturing: Better Processes Yield Better Results
Supply Chain Quality Management - A Case Study: Mitigating Risk in a Global Supply Chain
Enabling a Responsive, Demand Driven Supply Chain
How Chemical Regulations Could Disrupt Your Supply Chain: Why You Need to Design for Compliance
Information Advantage: Use Analytics to Gain New Insights from Existing Data Systems
Optimizing People Power: Achieve Exponential Productivity When Employees Embrace Continuous Improvement
Most of the sessions will give away a complimentary $100 gift certificate to five randomly drawn attendees. To register for one or more of the sessions, go to the Operations Excellence Online LIVE web site.
IWA 2:2007 - Use of ISO 9001 in Education
An International Workshop Agreement (IWA) is an ISO document produced through workshop meetings and not through the technical committee process. An IWA provides guidance and is not intended for use in contracts for conformity assessment or for certification.
IWA 2 was first published in 2003. The second edition, IWA 2:2007, Quality Management Systems - Guidelines for the Application of ISO 9001:2000 in Education, is now available.
IWA 2 provides guidance for a quality management system in an educational organization. It does not add to, change, or otherwise modify the requirements of ISO 9001:2000.
You can order IWA 2 at the ANSI e-Standards Store for $92.00. Other IWAs that may be of interest are:
IWA 1:2005 provides additional guidance for any health service organization involved in the management, delivery, or administration of health service products or services, including training and/or research, in the life continuum process for human beings, regardless of type, size and the product or service provided.
IWA 4:2005 provides local governments with guidelines for the voluntary application of ISO 9001:2000 on an integral basis.
Free Online EMS 101
The Environmental Protection Agency (EPA) web site has an online EMS 101 course that provides an overview of an Environmental Management System. The course also covers how an EMS program can support environmental improvements at facilities that are subject to environmental regulations. The free course takes about one hour to complete.
In addition, the course describes the EPA's involvement in supporting EMS efforts at facilities regulated under a number of environmental statutes, e.g., the Resource Conservation and Recovery Act (RCRA).
The web-based EMS training course has four modules.
Module 1: Introduction
Module 2: What is an EMS?
Module 3: EPA's Perspective on EMS
Module 4: Benefits and Examples of EMS
Each web page contains directions that help you navigate through the course. Arrows on the bottom of each page control movement from page to page. "Main messages" pop up throughout the module to reinforce its learning objectives. And, a short quiz is included at the end of each module to test your knowledge of the materials.
While at the EPA's home EMS Web Site, take the time to explore the other resources and publications available for your reference and use.
Whittington & Associates provides training, consulting and auditing services for
quality systems based on
ISO 9001, ISO/TS16949, TL9000, AS9100, ISO 13485,
as well as, ISO 27001, ISO 20000, ISO 22000, and ISO 14001.
