Featured Product
This Week in Quality Digest Live
Standards Features
William A. Levinson
New process is qualitative rather than quantitative
Michael Lueck
Computer system, cutting corners, self-certification all play a part
Miriam Boudreaux
Stop fighting the auditors and get back to basics
Dirk Dusharme @ Quality Digest
The world affects your job, and you affect the world. Take pride in your work.
Quality Digest
Here’s a sample of some of the stories our readers found most interesting in 2019

More Features

Standards News
Awards to be presented March 24, 2020, at the Quest for Excellence Conference, in National Harbor, MD
How the nation’s leading multistate cannabis company ensures quality and safety standards
New auditors must pass the exam before auditing for GFSI-recognized certification programs
ISO and WHO are working for universal access to quality health products that are all at once safe, effective, and affordable
Streamlines shop floor processes, manages nonconformance life cycle, supports enterprisewide continuous improvement
Allows construction industry to collaborate across projects and national borders
Enhances accreditation services portfolio across global market
Features illustrations as applied in real-world organizational contexts
Standards like ISO 10303 and ISO 14306 help to keep planes high in the sky

More News

Chad Kymal

Standards

Implementing ISO 9001, ISO 14001, and ISO 45001

How to define context and expectations for effective planning

Published: Wednesday, October 21, 2015 - 11:23

The outward focus of an organization comes from defining the context, mission, vision, policies, and interested-party expectations. A company’s goals and objectives provide the lens through which this outward focus can be seen (figure 1).

Setting the strategic direction

An organization uses its business context to identify the internal and external issues that are key to driving its actions. ISO 9001:2015 defines context as the “external and internal issues that are relevant to [a company’s] purpose and its strategic direction, and that affect its ability to achieve the intended result(s) of its quality management system.” In a large organization the context of each warehouse, design center, or plant can be different. Of course, there are some common issues, but the local conditions, employees, customers, and culture bring unique issues. For example, the contextual issues for a medium-size automotive supplier could be the lack of new employees with reading and writing skills, a significant number of non-English speakers in the workforce, reduced profitability, increasing pressure for cost reduction, overseas competition in its core segment, a strong union, and increasing IT and process technology. These would most likely be different from the contextual issues facing a design center.

The contextual issues, along with mission, vision, policies (e.g., quality, environmental, and health and safety), and interested-party expectations will allow the company to set its strategic direction. The interested parties, such as corporate, end customers, county, state, government, suppliers, and employees will need to be queried for their needs and expectations. The expectations will need to be listed, grouped, and ranked from the viewpoint of interested-party expectations. Some expectations may be on-time budget reporting, minimum returns from corporate, increased level of quality required from key customers, pressure for social responsibility, carbon footprint reduction, industrial waste reduction, compliance to Occupational Health and Safety Advisory Services (OHSAS) and Environmental Protection Agency (EPA) regulations, and corporate requirement for zero accidents.

The expectations gathered from interested parties could lead to the following grouped expectation categories: improve outgoing quality, reduce health and safety accidents, reduce carbon footprint, increase compliance to EPA and OSHA, and reduce costs.


Figure 1: Goals and objectives

For example, a company might set goals such as external quality of 30 PPM and two customer incidents/month, 100-percent on-time delivery, reduce carbon footprint by 30 percent, increase process technology to increase productivity by 18 percent, zero compliance issues, and others. It’s interesting to note that this process is not restricted to quality, environmental, or health and safety, but is a holistic process and focuses on the overall business.

Setting an internal focus: the organizational dashboard

The goals and objectives are translated to top management key performance indicators (KPIs) that can be viewed in a trend chart with a goal line, showing the as-is and the to-be. The KPI in our example is a goal of 30 PPM or a carbon footprint chart with the goal of a 30-percent reduction from XX lbs to YY lbs. Each of the KPIs are supported by the key processes and process measures that are correlated with it.

As shown in figure 2, the 30 PPM goal is correlated with new product development, problem solving, and supplier processes. This alignment between KPIs, key processes, and process KPIs is repeated for each of the goals and objectives.


Figure 2: The organizational KPI can only be achieved by improving the process KPIs in the key processes. Click here for larger image.

The management system and its intended results

A management system is defined in ISO 9000, ISO 14001, and ISO 45001 as a “set of interrelated or interacting elements of an organization to establish policies and objectives and processes to achieve these objectives.” In a business operating system the outward focus of context, mission, vision, and policies helps “establish policies and objectives,” and the inward focus from KPIs helps establish the “processes to achieve these objectives.” In a business operating system, the processes need to be improved to achieve the KPIs and the overall objectives. So the business operating system then defines the management system as defined in ISO 9000:2015 or ISO 14001:2015 or ISO 45001.


Figure 3: Content, mission, expectations and KPIs. Click here for larger image.

The intended results of the management system are the organization’s goals and objectives as they relate to quality, environmental, and health and safety. The organization ensures the intended results through its key processes.

Risks and opportunities: integrated risk

Risks and opportunities are analyzed in the key processes. The key processes are a part of the overall organization’s business processes. There is only one process map for the organization; there are no separate process maps for quality management systems, environmental management systems, or occupational health and safety management systems. However, some of the key processes correlate with quality objectives, while others correlate with environmental and health and safety objectives.

Omnex uses an integrated risk process to assess the quality, environmental, or health and safety risks of the relevant processes. Risk is defined as severity or impact multiplied by occurrence or likelihood. When analyzing risk in a process, the events that might occur to keep that process from achieving its overall objective can drive the risk analysis. With environmental risk, for example, the events and their impacts are analyzed to identify the significant aspects that interact with the environment. For health and safety, risk analysis focuses on hazard analysis.

There is no shortcut to conducting quality, environmental, or health and safety risk analysis. However, the same team can work with the same process. Using process, family-based risk analysis and the same risk analysis companywide are effective strategies.

Omnex EwQIMS software not only has implemented the business operating system, but has also integrated risk in its risk module.

Join Chad Kymal, CTO of Omnex on Oct. 29, 2015, as he presents the webinar, “Implementing Context, Interested-Party Expectations, and Planning for ISO 9001:2015, ISO 14001:2015, and ISO 45001,” using the EwQIMS software to share a case study.

Discuss

About The Author

Chad Kymal’s picture

Chad Kymal

Chad Kymal is the CTO and founder of Omnex Inc., an international consulting and training organization headquartered in the United States. He is also president of Omnex Systems, a software provider of ISO 9001, ISO 14001, and ISO 27001 management systems. He developed and teaches auditor training for ISO 9001, IATF 16949, ISO 14001, and ISO 45001, as well as an Integrated Management Systems Lead Auditor training course where all three standards are combined in a single audit.

Kymal is also on the ISO/TC 176, ISO/TC 207, and PC283 committees for ISO 9001:2015 (quality), ISO 14001:2015 (environmental), and ISO 45001 (health and safety) management system development.