In ISO/IEC 17025-accredited laboratories, standard operating procedures (SOPs) serve as the backbone of quality assurance, especially in quality control (QC) environments where consistency and regulatory compliance are paramount.
However, when operating advanced analytical instruments such as GC-MS, HPLC, LC-MS, LC-MS/MS, GC-MS/MS, and ICP-MS, a level of expert judgment and real-time decision-making is often required that rigid SOPs may not fully accommodate. While research and development (R&D) laboratories thrive on innovation and minimal procedural constraints, they too benefit from structured SOPs for tasks like research planning and method validation.
This article focuses on the need to balance SOP compliance with expert flexibility in QC laboratories and proposes a dual-level control model that upholds ISO/IEC 17025 compliance while enabling operational adaptability.
The challenge with rigid SOPs
SOPs are generally designed for standard conditions and routine scenarios. However, real-world analytical work frequently encounters:
- Matrix interferences
- Instrument drift or anomalies
- High-throughput variations
- Analyte instability
Over-restriction through SOPs can hinder an expert analyst's ability to apply timely solutions, optimize methods, or troubleshoot issues efficiently.
Tiered operational control: Balancing SOP discipline and expert flexibility
A tiered control framework helps laboratories balance routine SOP compliance with the operational flexibility required when using advanced instrumentation. This structured approach recognizes the varying levels of analyst expertise and assigns responsibilities accordingly.
Dual-Level Operational Control | |||
Level | Operator Profile | Documentation | Flexibility |
Level 1 | Trained analysts (routine users) | Follow SOPs | Minimal; Supervisor approval required for deviations |
Level 2 | Expert Analysts (instrument in-charge, with high qualification and proven experience in the related field) | SOP + embedded instructions/authority in SOPs | Permitted real-time adjustments with justification |
How it works
Level 1 analysts follow routine steps strictly as per SOPs.
Level 2 analysts—whose competency is validated in the laboratory's competency matrix—are permitted limited operational discretion. Flexibility is managed through SOP notes or logs reviewed during audits. It is vital that the expert’s observations are documented, along with any changes to the SOP, including why the change was made.
This method ensures ISO/IEC 17025 compliance while allowing method optimization and real-time problem-solving.
Note: Level 2 analysts do not require additional training for these tasks. Their responsibilities are assigned based on demonstrated expertise, professional qualifications, and recognized authority in the subject. They are granted autonomy to make informed, real-time decisions.
Implementation and competency-based authorization:
To support this model:
- Define competency requirements and authority scope for Level 2 analysts.
- Document their flexibility and authority directly within the SOP under the “Responsibilities” or “Exceptions” section.
- Ensure all operational decisions are documented and traceable through batch records, LIMS, or logbooks.
- Review any exceptional interventions during internal audits or technical management meetings.
ISO/IEC 17025 compliance justification
The standard allows operational flexibility when:
- Competency is proven (Clause 6.2)
- Method suitability is verified (Clause 7.2)
- Records of decisions and deviations are maintained
- Many labs already have a deviation process within the quality system.
- The dual-level control approach enhances this framework by allowing operational deviations to be initiated and justified by the laboratory expert, rather than waiting solely on quality management review. This alignment speeds up problem-solving while maintaining traceability and ISO/IEC 17025 compliance.
- This dual-level model also enhances risk-based thinking and aligns with Clause 8.5 (Actions to address risks and opportunities).
Structuring documentation for flexibility and compliance
To support a tiered flexibility approach, documentation must be structured in a way that distinguishes between fixed instructions and areas where discretion is allowed.
Lab Quality Management Certificate
The Lab Quality Management certificate is more than training—it’s a professional advantage.
Gain critical skills and IACET-approved CEUs that make a measurable difference.
In ISO/IEC 17025-accredited laboratories, documented information is categorized into different levels depending on the depth and specificity of the content.
These layers provide flexibility in documentation. For example, a procedure may allow certain decisions to be made by a qualified analyst, while the SOP outlines exact steps with conditional provisions for deviations. Work instructions support technicians with precise actions, and guidelines offer expert-informed directions for less-regulated areas like research.
Document Type | Purpose | Scope |
Procedure | Describes what needs to be done and who is responsible | Broader process or activity |
SOP | Details how to perform a specific task consistently | Method or operation-specific |
Work instruction | Provides step-by-step actions, often for complex tasks | Task-level |
Guideline | Offers recommendations or best practices | Advisory in nature |
Proficiency vs. creativity in lab environments
Laboratory roles and expectations vary widely depending on the operational context. In QC laboratories, the focus is on regulatory compliance and reproducibility. These environments demand high proficiency, with SOPs tightly guiding all steps to reduce variability and ensure method integrity. SOP compliance ensures that procedures are carried out consistently across analysts and over time.
However, even in QC environments, when highly sophisticated instruments such as GC-MS, LC-MS/MS, or ICP-MS are used, flexibility becomes essential—particularly at senior levels. Analysts responsible for executing methods and validating results may need to make real-time decisions and troubleshoot unexpected issues, which must be documented and controlled through SOP-defined responsibilities and authorization levels.
In contrast, Research & Development (R&D) laboratories thrive on creativity. These labs explore new methods, develop techniques, and optimize workflows. Rigid SOPs, if applied too strictly, can hinder innovation—the core objective of research. R&D laboratories already operate with SOPs as a strategic framework—covering planning, safety, and quality—while maintaining flexibility in method development. This practice is well established and is included here briefly for context, without extensive elaboration.
Conclusion
In advanced analytical laboratories—both QC and R&D—the intersection of SOP discipline and expert flexibility is crucial. A structured system that respects both can lead to:
- Improved efficiency
- Reduced turnaround time
- Enhanced data integrity
This approach is vital in analytical environments where method optimization, real-time troubleshooting, and advanced decision-making are part of daily operations.
QC laboratories should prioritize high proficiency and compliance while providing limited flexibility to senior analysts for troubleshooting and complex decisions. Conversely, R&D labs require creativity at all levels to foster innovation and develop robust, future-ready methods. SOPs in R&D should support strategy and documentation while allowing the necessary technical freedom.
