Utilizing OPM3® to support PMO's efforts to integrate ISO standards and the PMBOK® Guide
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The Project/Program Management Office (PMO) plays a key role in integrating relevant standards and best practices while developing a successful project management methodology for an organization. The recent release of the International Organization for Standardization (ISO) 21500:2012 Guidance on Project Management, has contributed to the complexity of standards and best practice integration, while also providing the opportunity for organizations to show project management process conformance through an internationally recognized process.
To address these challenges, the Department of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (VA CSPCRPCC) employed an approach using Project Management Institute's (PMI) the Organizational Project Management Maturity Model (OPM3®) as a framework to assess their current state, define common terminology in the organization, recognize their internal best practices, and identify areas of improvement. The OPM3® framework and OPM3® ProductSuite tool provided an approach to aligning internal processes with A Guide to the Project Management Body of Knowledge (PMBOK® Guide)/ ISO 21500 and the results served as a key input to their continuing ISO 9001:2008 registration process.
VA CSPCRPCC (hereinafter referred to as “the PCC”) is part of the Department of Veterans Affairs (VA), Office of Research and Development, Clinical Sciences R&D and supports VA investigators by managing the pharmacy-related aspects of worldwide multicenter clinical trials conducted for the VA and other federal organizations. The PCC was established in 1972 with four employees and today has 111 employees. The PCC has collaborated in the planning and conduct of more than 200 multicenter clinical trials. Clinical research pharmacists, pharmaceutical project managers, administrative and technical staff provide support for project management, manufacturing, drug testing, packaging, labeling, central distribution, inventory accountability and monitoring the safety aspects of clinical trials.
The PCC has a strong commitment to performance excellence and pursues external verification of their product and service quality as part of this commitment. Their journey began in 1993 when they received their FDA current Good Manufacturing Practices (cGMP) registration and continued with ISO 9001 registration in 2003, ISO 15378 registration in 2009, and receipt of the Malcolm Baldrige National Quality Award in 2009. Since 2009, the PCC has continued to develop their quality management system and understands how to improve their key processes: Pharmaceutical Project Management, Production, and Regulatory. The PCC‘s pharmaceutical project management key process has been a focus for improvement and alignment with their quality management system since 2007, using the PMBOK® Guide and OPM3®.
Aligning Standards Using a Quality Hierarchy
Developing a Quality Hierarchy
The PCC developed a Quality Hierarchy to align multiple standards in their quality journey and to explain their approach to staff and stakeholders (See Exhibit 1). The PCC‘s Quality Hierarchy was developed using concepts from Tsiakals’ model (Tsiakals, 2002, pp. 27–33) to unify the application of VA, Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and Environmental Protection Agency (EPA) regulatory requirements (Regulatory Compliance) at the base and ISO 9001 (Effectiveness) at the center of the pyramid as the quality management system. The Malcolm Baldrige National Quality Award (MBNQA) Criteria as the performance excellence model, is at the apex of the pyramid (Competitive Advantage and Efficiency).
Exhibit 1 – The PCC's Quality Hierarchy
Building a Project Management (PM) Hierarchy
Since 2002, the PCC has used the PMBOK® Guide to develop common terminology for efforts to standardize their project management processes. In 2007, the PCC began using OPM3® with the PMBOK® Guide to continue improving and aligning their pharmaceutical project management key process. OPM3® provided a broader context to assess processes in the Project, Program and Portfolio domains. As work with the PMBOK® Guide and OPM3® progressed, a Pharmaceutical Project Management (PPM) Hierarchy (Exhibit 2) emerged to provide context for alignment of these standards with the PCC‘s existing Quality Hierarchy.
Exhibit 2 – Example Pharmaceutical PM Hierarchy Aligned for Synergistic Results
Using the PPM Hierarchy for Synergistic Results
Using the PPM Hierarchy proved invaluable to align quality and project management standards for synergistic results versus the competing positions these standards are sometimes placed within organizations. Development of the PPM Hierarchy was the first element needed to integrate ISO standards and the PMBOK® Guide. The PPM Hierarchy provided recognition and alignment to the quality standards with the well established Quality Hierarchy. With a framework of alignment in place, the PCC moved on to leverage OPM3® results to establish and further develop PCC‘s Project Management Methodology/Framework.
Using OPM3® to define an Organization's Project Management Methodology/Framework
Using OPM3® to Drive Improvement and Change
Starting with the self-assessment instrument OPM3® Online tool in 2007, the PCC quickly realized an increased rate of change in their organization's focus and implementation to standardize their project management process. The self-assessment instrument provided visibility to the areas of program and portfolio management, including their interrelationship with individual project management processes represented in the PMBOK® Guide. The self-assessments were used periodically until the organization moved to using the OPM3® ProductSuite tool in 2011. The decision to move to the ProductSuite Tool was based on the multi-dimensional view of project management maturity (PMI, 2008, p 2) and the formal results analysis/improvement plans this tool provides.
Using the OPM3® ProductSuite Tool to Assess Conformance to Standards
“An OPM3® Maturity Assessment is flexible enough to be used to assess maturity in these different focus areas: (1) Specific domains (project, program and/or portfolio); (2) Organizational Enablers; and (3) Specific stages of process improvement (standardize, measure, control, or continuously improve).” (PMI, 2008, p 5) PCC‘s PMO leveraged this flexibility and targeted the focus of their first internal assessment in the project domain and standardize improvement stage.
The PMO used the first assessment as an opportunity for PMO staff to formally map the organization's project management processes, best practices, and terminology to the PMBOK® Guide. This map provided a detailed view of conformance to the PMBOK® Guide and served as a vehicle to secure buy-in by PMO staff members of OPM3® results. Most organizations cannot change all their terminology to the PMBOK® Guide terms. Setting up a formal map to terms proved to be invaluable in training staff and developing improvement plans that are accepted and embraced by the project managers working in the PMO. The summary of PCC‘s results (Table 1) shows PCC‘s high degree of standardization in the project domain, standardize improvement stage.
Table 1 – PCC's OPM3® Results Summary
|Possible Score||Available Score*||Awarded Score||score (%)||Best Practices Achieved|
|Organizational Enablers Area||684||651||565||87||48|
|OPM3 (Overall Score)||1188||1155||982||85||57|
*Some questions were marked “Not Applicable” for the PCC organization
How OPM3® Results Supported Development of Project Management Methodology
The results were not a surprise, as the organization had begun their work on standardizing project management processes in 2002, but the formal score provided a leverage point for the PMO to delineate a role for PMI standards within the organization. The PCC continued development of the organization's project management methodology within the existing policies and procedures it uses to manage and deliver their products and services. These are the same policies and procedures the organization uses to assure compliance with ISO 9001 and ISO 15378:2011 (Primary packaging materials for medicinal products). With this approach, synergy between PMI and ISO standards was started in the organization. This foundational work would be needed to take the next step in achieving tighter integration with the PCC‘s ISO 9001 registration/audit process.
Using ISO and PMI Standards as a Foundation of Project Management Standardization
ISO 9001 Registration/Audit Process Overview
Understanding the ISO 9001 registration/internal and external audit processes are a key step to implementing quality systems that are synergistic with other relevant standards. The audit processes are conducted over a three-year period for most organizations. Prior to an initial registration a stage 1 audit is conducted by an auditor of a certifying body. The quality manual and qualifying procedure for adherence to procedures are sent in advance for review. Then a stage 2 onsite audit verifies compliance to the quality management system outlined in the organization's quality manual. On years two and three of this three-year cycle, surveillance audits are conducted to keep an organization's ISO 9001 registration active. Surveillance audits focus on evaluation of key ISO required processes and selected organizational processes that are audited in depth. It is in the surveillance audits where opportunities to develop synergy with other ISO and PMI standards resides.
Defining Project Management as a Key Process in Your Organization's Quality System
Many organizations utilize ISO 9001 as a driver to manage the quality of their service/product oriented processes. Usually the organization's PMO uses the PMBOK® Guide and other relevant PMI Standards to provide a framework for their project management methodology and culture development. In this ISO 9001 environment and culture, PMOs can struggle to harmonize project management methodology/standards with the quality management system set forth in the ISO 9001 registration/audit processes. Initially, PMOs should work to have project management designated as a key process in their organization's quality management system. This step provides an organizational leverage point to align ISO 9001 and the PMBOK® Guide in an organization's journey to consistently provide products and services that meet or exceed customer requirements, regulatory standards, and customer satisfaction, while ensuring continuous improvement and seeking to prevent both product and service nonconformity.
ISO 21500 Provides a Hidden Opportunity to Build Project Management Culture
With the introduction of the ISO 21500:2012 Guidance on Project Management in 2012 (herein referred to as ISO 21500), a layer of complexity was added to the PMO‘s standards alignment responsibilities. But a hidden opportunity arose to use ISO 21500 as a vehicle for demonstrating project management process conformance within the ISO 9001 framework already in place in many organizations. The PCC seized this opportunity to further build their project management culture while tightening integration of their quality management system with their project management methodologies. In an arena of increasing scrutiny of government financial and risk management practices, the external review of PCC‘s project management practices to determine conformance to international standards was deemed beneficial to its stakeholders and was supportive of the organization's overall commitment to performance excellence.
The PCC‘s previous experience of including additional standards in their ISO 9001 process started with ISO 15378:2011 (Primary packaging materials for medicinal products) to address specific requirements in their key process Production. ISO 15378, which was created to assist European pharmaceutical companies to manage their supply chain with packaging material suppliers, is applicable to pharmaceutical companies, including the PCC. By simply translating the terms “primary packaging materials” to “drug products,” the ISO 15378 International Standard aligned with PCC‘s products and services. What is unique about this ISO 15378 is that it encompasses the entire ISO 9001 Standard, and strengthens it by adding additional clauses and specifications where they are needed for FDA-registered Drug Establishments. This experience with including ISO 15378 supported a logical progression for the PCC to include ISO 21500 to address specific requirements of another key process Pharmaceutical Project Management.
Convinced of the opportunity ISO 21500 presented, the PCC began the process of evaluating how to include or embed ISO 21500 in their ISO 9001 based quality management process. At this point, the previous work using OPM3® delivered additional benefits. The project domain and standardize stage of OPM3® aligned with the ISO 21500. The barrier to adopting ISO 21500 was neutralized by the using OPM3® ProductSuite previously to assess PCC‘s current state.
Steps to Include ISO 21500 in PCC‘s ISO 9001 Audit Process
The first step in defining an ISO framework that includes ISO 21500 is to understand the role of project management in your organization's Quality Management System. ISO 9001:2008 has nine clauses, as shown in Exhibit 3. The organization must describe how it meets the ISO 9001 requirements for each clause.
Exhibit 3 – ISO Clauses Overview
As the PCC evaluated how to harmonize ISO 21500 project management requirements with their ISO 9001 quality management processes, their Quality Manager identified the first step needed was to update clause 4 of the PCC‘s Quality Manual to better reflect the organization's interrelated value-adding processes. Two key elements were identified: (1) Increase visibility of the phases of the work in the organization and align with the organization's Work Breakdown Structure (WBS) used in their project management scheduling and cost management process and (2) Show Project Management as a Key Process along with the additional key processes needed for service/product delivery. Once project management was identified as one of the organization's key or value adding processes, the foundation for a synergistic environment for ISO 21500 and ISO 9001 based quality system was defined. (See Exhibit 4 for the PCC‘s approach to defining their interrelated value-adding processes)
Exhibit 4 – Example Quality Management System Processes with Pharmaceutical PM Elements
Using OPM3® Results to Include ISO 21500 as Part of ISO 9001 Audit Processes
Understanding the Guidance Component of ISO 21500
ISO 21500 provides a high level approach relative to the processes listed in the standard when it states: “These project management processes are appropriate to projects in all organizations. Project management requires significant coordination and, as such, requires each process used to be appropriately aligned and connected with other processes….the project manager should tailor the management processes for each project or project phase by determining what processes are appropriate and the degree of rigor to be applied for each process. This tailoring should be accomplished in accordance with the relevant organizational policies.” (ISO, 2012, p 9)
It is this concept of tailoring or discernment by a PMO of what is appropriate for an organization that establishes ISO 21500 as a guidance-type standard versus a compliance standard like ISO 9001 or ISO 15378. ISO compliance standards do not have the component of tailoring, and deviations to the standard must be filed when requirements do not apply.
Using ISO 21500 in a ISO 9001 Process
As discussed earlier, the OPM3® ProductSuite assessment, conducted previously for the project domain and standardize stage, aligned with ISO 21500. Additionally, the OPM3® assessment identified areas of improvement that PCC was already working on to address. This work provided a mechanism for the PMO to establish a degree of rigor and tailoring for their project management methodology. This methodology was embedded in existing policies, procedures and governance structures. This approach addresses the issue of including a guidance-type standard, like ISO 21500 in the compliance environment of the ISO 9001 registration/audit process.
How OPM3® Results Support Preparing for Using ISO 21500
The OPM3® assessment results and improvement plan served as the centralizing force to improve and strengthen the organization's project management methodology embodied in their organization's policies and procedures. Connecting the improvement plan to the ISO 9001 audit deadline, the PCC was positioned to achieve the project management culture needed faster than expected, which is beneficial for their dynamic environment.
As the group implemented the needed improvements in the policies and procedures, additional mapping to ISO 21500 was conducted. No significant gaps were identified due to the close alignment between ISO 21500 and OPM3®/the PMBOK® Guide. During the ISO 9001 audit of the organization's study design and management process, the conformance to ISO 21500 was evident. The organization's quality and project management cultures now have synergistic rather than competitive alignment, leading to an overall improvement of the PCC‘s quality management system.
Lessons Learned from the Audit
During the process, lessons learned were collected to facilitate improvement and alignment of the organization's key processes and to strengthen their quality management system. (See Table 2)
Table 2: Summary of Lessons Learned
|1||Conduct a comprehensive gap analysis of your organization's project management methodology, culture and processes first. (Tools such as OPM3® ProductSuite provide a multi-dimensional view of your organization).|
|2||In an ISO-oriented culture, using ISO 21500 can increase the rate of change in developing a mature and robust project management culture that is synergistic with your quality culture.|
|3||Conducting formal assessments using tools such as OPM3® and standards such as ISO 21500 supports a PMO to gain recognition for the work your organization has accomplished.|
|4||ISO 9001 is strengthened by using ISO 21500.|
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© Biomedical Research Institute of New Mexico (BRINM)
Originally published as part of 2013 PMI Global Congress Proceedings – New Orleans, Louisiana