Q: What’s the best way to implement ISO 9004:2009 at an organization?
Bastine Paul Attokaren
A: There are three steps to implementing ISO 9004:2009:
1. Identify long-term objectives. The standard defines sustained success of an organization as "a result of the ability of an organization to achieve and maintain its objectives in the long term."
The starting point on this path is to define the organization’s long-term objectives and align them with the long-term objectives and expectations of interested parties. For most organizations, interested parties include:
Value-added resellers, service centers, suppliers, subcontractors and other business partners can be added to this list, depending on the industry in which the organization operates. Examples of long-term objectives and expectations of interested parties include:
- Customers—compatibility of current and future products, product safety and mobility.
- Resellers—continuous industry leadership and innovative solutions.
- Suppliers—supplier involvement in the innovation process and sharing of strategic plans.
- Investors—continuous financial success and a growing return on investment.
- Society—environmental performance across the value chain and respect for human rights.
- Employees—health and safety at work, professional growth and continuous employability.
2. Conduct gap evaluation and assessment. An organization’s business processes and systems help it organize, coordinate and focus its activities on the achievement of established goals and objectives. An organization should evaluate and continuously reevaluate its business processes’ level of maturity to ensure they are capable of achieving established objectives.
A detailed self-assessment tool can be found in Appendix A of ISO 9004. This tool uses five maturity levels, and can help identify the strengths and weaknesses of business processes—a key checkpoint on the path to an organization’s sustained success.
There are several other evaluation frameworks relevant to business sustainability that an organization can use to assess the capabilities of its business processes, including:
- The Global Reporting Initiative Sustainability Reporting Framework (GRI), which is one of the most widely used methods for sustainability reporting. The GRI also is known as the G3 Guidelines, which were initially published in 2006 as a free public document.
- The Dow Jones Sustainability Indexes include a defined set of assessment criteria launched in 1999 as the first global sustainability benchmarks in the family of Dow Jones Indexes.
3. Manage, report and share knowledge. Based on the assessment results, an organization should create improvement action plans, which can include policy development, procedures, metrics and business practices.
For example, an organization evaluated its process to manage natural resources, which were at the first level of maturity, defined by ISO 9004 as: "The use of natural resources is managed in a very limited way."
The organization’s goal was to elevate this process to maturity level five, which is defined by ISO 9004 as: "The organization can demonstrate that its approach to the use of natural resources meets the needs of the present, without compromising the needs of future generations of society. There is liaison with, and benchmarking against, external organizations and other interested parties over the use of natural resources."
The progression from level one to level five can be done through the development and deployment of policies and metrics in the area of natural resources management. The organization also could establish business relationships with external parties to benchmark activities in this area and monitor best practices.
Results in the area of business sustainability should be disclosed to all interested parties in the form of reports, public announcements or newsletters. It’s also important to promote established good practices, standards and policies throughout the value chain.
The value chain includes value-added resellers, service centers, suppliers, subcontractors and other business partners. Knowledge dissemination can be done either through value-added auditing and certification of partners, or through training and support.
President and cofounder
Centauri Business Group Inc.
- International Organization for Standardization, ISO 9004:2009—Managing for the sustained success of an organization—A quality management approach.
Q: I just began a position as a quality assurance technologist in a hospital-based blood bank. I was wondering if you could walk me through a simplified root cause analysis (RCA) of an event that occurred a few months ago.
Patient specimens are sent to the blood bank with the patient’s name, medical record number, date drawn and identification of the person drawing the blood. A five-digit accession number is assigned to the specimen with a letter preceding the number to identify the day of the week drawn: M for Monday, T for Tuesday, W for Wednesday, H for Thursday, F for Friday, S for Saturday and X for Sunday.
After testing, the specimens are stored in a rack according to the last digit of the accession number. The rack is labeled with the day of the week and date. There are 10 rows in the rack labeled 0 through 9. The specimen is placed in the row number according to the last digit of the accession number. There are 14 days of racks.
A patient needed blood Wednesday, March 14, 2012. The specimen was tested Thursday, March 8, 2012, and the last digit of the accession number was "2." But the specimen could not be found in the rack labeled Thursday, March 8, 2012, row 2, and an emergency release of uncross-matched blood needed to be issued. The specimen was found the next day in the rack labeled Sunday, March 4, 2012, row 2.
A: You’re off to a good start in your new position by identifying this opportunity to conduct an RCA for a potentially serious event that occurred in your blood bank. You’ve outlined the beginning of a timeline. I would have staff expand the timeline to include information about physician and staff actions, patient actions, response and status, supervisory actions, policies and procedures, and standards.
The first step in an RCA is selecting a team. Potential members may include department management, blood bank staff and members of the medical staff. I also would recommend asking your hospital director of quality or risk management to assist.
The team’s focus should be on the system, with emphasis on preventing future occurrence rather than finding fault. To make sure all the team members understand the processes, have the team create a flowchart for the handling of patient specimens and retrieval for cross-matching process.
Next, have the team review the sequence of events from the timeline and identify items that might have contributed to the event. Was there any deviation from the generally accepted process flow? Then, the team should drill down into each of the contributory events and ask why it happened. The team can use a cause and effect analysis tool to carry out this task.
Based on what the team has identified as the causes for the contributory events, identify changes that could be made to the system and process to prevent this from happening again. Identified actions should concentrate on failure prevention for barriers embedded in the process so this type of event never happens again. Make sure you follow through and change policies, procedures, orientation and competencies to align with the identified changes.
ASQ’s website has many resources on RCA, developing a flowchart, and using the cause and effect tool.1 And if you’re looking for something a little more specific to healthcare, the Joint Commission on Accreditation of Healthcare Organizations has an RCA tool on its website that does a great job of walking you through the analysis.2
Director, quality improvement and safety
Alexian Brothers Senior Ministries
- ASQ, "Cause Analysis Tools," http://asq.org/learn-about-quality/cause-analysis-tools/overview/overview.html.
- The Joint Commission, "Framework for Conducting a Root Cause Analysis and Action Plan," www.jointcommission.org/assets/1/18/rca-word-framework.doc.