Over the years, the roles and responsibilities of Engineering and Quality/Validation have evolved for Commissioning and Qualification (C&Q) activities. Now more than ever, risk-based approaches rely heavily on Engineering Subject Matter Experts (SMEs) and the application of Good Engineering Practices (GEPs) as an Engineering Quality Process to underpin C&Q.
Under the Quality Risk Management (QRM) model, all testing adds value as verification activities; testing is commensurate with product risk; GEPs and Engineering SMEs are emphasized in the process; and Quality is focused on the identification, mitigation, control of risks to product quality and verification of the process risk control strategy. Under this model, GEPs as an Engineering Quality Process (EQP) enable the C&Q process.
However, historically, the Quality unit has not had sufficient trust in GEPs to facilitate their effective use in risk-based C&Q. Why has that trust been missing, and how can it be built?
Good Engineering Practice as a QRM-Based Integrated C&Q-Enabling Process
How does Good Engineering Practice enable QRM-based integrated C&Q?
GEP ensures that:
- Systems are specified, designed, installed, and operate in a manner that meets operational, maintenance, safety, health, environmental, ergonomic, industry, statutory, and regulatory requirements – including GxP requirements
- Process risks to product quality are identified, assessed, and mitigated in system design, installation, and operation
- Appropriate planning, specification, design, installation, verification, acceptance, and maintenance documentation is created throughout the system lifecycle
- Suitable oversight and control are provided for construction, installation, and execution verification activities
In short, the GEP systems that enable QRM-based integrated C&Q – including design review, engineering change management, good documentation practice, document/drawing control, vendor qualification, construction quality, commissioning, issue/punchlist management, and asset management – comprise an Engineering Quality Process that underpins the C&Q process. Appropriate engineering SMEs define system requirements and then specify, design, and verify the system in an efficient, effective, integrated approach. By relying on a robust, mature Engineering Quality Process built on GEP, the Quality unit – and analogous Quality Systems, including quality change control, good documentation practice, document control, deviation management, CAPA, etc. – can adequately focus on product quality and patient safety.
Using this approach, responsibilities, and focus can be aligned effectively and efficiently:
- The Engineering responsibility is system delivery, with an emphasis on documenting system fitness for purpose.
- The Quality unit responsibility is product quality, with a focus on verifying critical system fitness for purpose.
Current Industry GEP
In practice, GEP is generally not viewed as an Engineering Quality Process necessary to support Quality/Validation. GEPs may be followed as a matter of procedure or seen as a non-value-added hindrance to project progress. In general, GEP systems lack in robustness, maturity, implementation, and/or compliance, and are therefore not suitable for underpinning a QRM-based integrated C&Q approach.
This state of affairs leads to two significant outcomes:
- Many current C&Q approaches produce an “it’s only Commissioning, it will be verified during Qualification” mindset that results in the bulk of engineering SME commissioning effort being focused on aspects of the system that do not impact product quality – exactly the opposite of where engineering SME effort should be focused.
- The Quality unit, without sufficient trust in GEP as an Engineering Quality Process, then requires analogous Quality Systems to be used to provide appropriate oversight and control of all C&Q activities. The result is additional, less efficient, and more costly processes as well as additional documentation, testing, and effort with no commensurate, additional reduction or mitigation of product quality risk.
In other words, Engineering and Quality are focused on exactly the wrong things, hindering their ability to fulfill their responsibilities effectively or efficiently.
The Cost of Poor (Engineering) Quality
So, what happens as a result? Some real-world examples:
- A turnover package (TOP) found as unacceptable by Validation, which takes a “we cannot start protocol generation until the TOP is ready” stance without assessing impact to product quality, resulting in a day-for-day slip of protocol generation, which can quickly impact the overall project schedule.
- Hundreds of discrepancies observed during Engineering verification testing, using multiple-page forms with multiple steps and signatures for issues that have no impact on product quality, such as incorrect make or model number. In the end, the conclusion is “as-installed meets requirements, update the specification.” Such Quality oversight adds little to the resolution of these discrepancies while adding considerable churn and time to the project.
- Drawing redlines during field walks months after receipt and installation, resulting in a determination that OQ cannot start until IQ is complete without assessing the acceptability of as-found conditions or impact to product quality, and causing delay due to drawing review and update.
- The belief that functional or operational verification (traditionally called OQ) cannot start until all predecessor systems are “qualified”. For example, requiring all feed and intermediate systems in a pharmaceutical water train (municipal water supply, soft water, RO water, WFI) to be qualified as a prerequisite to qualifying a clean steam generator, resulting in a false critical path.
- Continuity and loop checks performed by the electrical vendor with poor or no documentation or not approved by Quality, that are repeated by the C&Q team. In-place loop calibration performed by instrument services through automation but not considered to be valid verification testing since it was not performed using a Quality pre-approved protocol, that is repeated by the C&Q or Automation team.
The Engineering mindset of “get the project done and validation will find the problems and provide the documentation” cannot be maintained. Engineering must embrace the efficiency gained through a robust, GEP-based Engineering Quality Process.
The New Capital Project Reality
Capital project timelines are shrinking due to the accelerated approval process, agile manufacturing, and pressure to increase speed to market. Corporate engineering is challenged to deliver projects in record time. The typical phase-gate model is being replaced by agile and/or concurrent activities and value-engineering approaches, and there is much less tolerance for repeated testing and issue discovery during startup, debug, and engineering runs. Companies executing capital projects need to find ways to acceptably cut the equipment testing timelines drastically (maybe even by half) to achieve their product launch goals.
Building Trust Between Engineering and Quality
Building trust between Engineering and Quality may require procedural and cultural change for Engineering as well as a paradigm shift for Quality. GEP systems need to be viewed as a good business practice that ultimately delivers the project earlier with fewer issues and as a critical component of QRM-based integrated C&Q.
Systems may need to be developed or matured (a spreadsheet on an engineer’s computer will not suffice for engineering change management). The suitability of GEP systems to support and enable QRM-based integrated C&Q may need to be demonstrated through engineering product quality on trial or pilot projects. And the Quality unit will need to change from a project quality mindset to a product quality focus.
The good news is, in most cases, both Engineering and Quality welcome and desire this change. Engineering wants to deliver systems that meet requirements, and the Quality unit wants to focus on product quality instead of having their effort diluted by overseeing aspects of project delivery that do not impact product quality.
How CAI Can Help
How beneficial would it be to your company to have engineering SMEs focused on successful, efficient project delivery and the Quality unit focused on product quality?
Good Engineering Practice underpins QRM-based integrated C&Q and facilitates more-efficient, more-effective, and less-costly project delivery. CAI can help you develop your Good Engineering Practices and a QRM-based integrated C&Q approach using the latest industry practices. CAI had two authors on ISPE Baseline Guide Volume 5 2nd Edition, released this year, and four authors on the original ASTM E2500 standard, published in 2007. CAI has executed multiple using a QRM-based integrated C&Q approach per the principles defined in ISPE Baseline Guide Volume 5 2nd Edition, ASTM E2500, and ICH Q9. Leverage our experience to optimize your C&Q program and deliver your projects more quickly with increased compliance and reduced costs.
Reach out to our experts to learn more about how we can help you bridge the gap between engineering and quality/validation.
About the Author:
Chip Bennett, PMP
Chip, Assistant Director, Global C&Q and a PMI® Certified Project Management Professional (PMP), is a Project Manager and Senior Validation Engineer with 19 years of experience in the pharmaceutical and regulated non-pharmaceutical industries with expertise in risk-based verification, quality systems, and owner project management. Chip is a CAI Subject Matter Expert in Quality Risk Management (QRM), Commissioning and Qualification, and CQV Program Development. He has achieved internal Tier III qualification in Owner Project Management (OPM), Quality Risk Management (QRM), Aseptic Manufacturing, and CIP/Cleaning Validation.
FDA Pharmaceutical cGMPs for the 21st Century: https://www.fda.gov/downloads/drugs/developmentapprovalprocess/manufacturing/questionsandanswersoncurrentgoodmanufacturingpracticescgmpfordrugs/ucm176374.pdf
FDA Guidance for Industry – Process Validation (2011): https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf
Eudralex Volume 4: https://ec.europa.eu/health/documents/eudralex/vol-4_en
ASTM E2500: https://www.astm.org/Standards/E2500.htm
ISPE Baseline Guide Volume 5: https://ispe.org/publications/guidance-documents/baseline-guide-volume-5-commissioning-qualification