Standardized Laboratory Workflows
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Standardized Laboratory Workflows
Standardized laboratory workflows are defined, repeatable processes used to perform laboratory activities consistently. By establishing clear procedures for receiving materials, identification, preparation, handling, storage, analysis and documentation, laboratories can reduce avoidable variation and improve traceability, consistency and reproducibility.
What Are Standardized Laboratory Workflows?
Standardized laboratory workflows are documented and repeatable sequences of laboratory activities designed to ensure that routine processes are performed consistently according to defined requirements.
A standardized workflow establishes what should happen, in what order, and what information should be recorded. The exact workflow depends on the laboratory activity, material, analytical method and quality requirements.
What Are Standardized Laboratory Workflows?
A standardized laboratory workflow is a defined sequence of activities used to complete a laboratory process in a consistent manner.
Workflows can cover individual activities or connect multiple stages of a laboratory operation. For example, a material-management workflow may begin with receiving and inspection and continue through identification, inventory placement, storage and eventual use.
Standardization does not mean that every laboratory activity must be identical. Instead, it establishes appropriate controls for processes where consistency, traceability or reproducibility is important.
Why Does Workflow Standardization Matter?
Laboratory processes often involve multiple people, materials, instruments and documentation steps. Without clearly defined workflows, differences in how individual activities are performed can introduce avoidable variability.
| Workflow Benefit | How It Supports Laboratory Operations |
|---|---|
| Consistency | Helps personnel perform recurring activities using the same defined approach. |
| Traceability | Creates a structured record of important laboratory activities. |
| Training | Provides personnel with defined procedures to learn and follow. |
| Quality control | Establishes checkpoints where important requirements can be verified. |
| Reproducibility | Reduces unnecessary differences between experimental runs. |
| Deviation identification | Makes it easier to recognize when a process differs from the expected workflow. |
Key Elements of a Standardized Laboratory Workflow
A useful workflow should clearly define the major activities, decision points, responsibilities and records associated with a process.
Typical Workflow Components
- Defined starting point
- Material or sample identification
- Required equipment and resources
- Sequential process steps
- Quality-control checkpoints
- Acceptance or rejection criteria where applicable
- Required documentation
- Deviation handling
- Defined completion or disposition step
The appropriate level of detail depends on the complexity and risk of the laboratory activity.
Standard Operating Procedures
Standard Operating Procedures, commonly called SOPs, provide documented instructions for performing defined laboratory activities.
An SOP can help establish consistency by describing the expected procedure, required materials, responsibilities, safety considerations and documentation requirements.
| SOP Component | Potential Purpose |
|---|---|
| Title and identifier | Identifies the specific procedure. |
| Purpose | Explains what the procedure is intended to accomplish. |
| Scope | Defines where the procedure applies. |
| Responsibilities | Identifies relevant personnel roles. |
| Procedure | Defines the required workflow. |
| Documentation | Identifies records that should be maintained. |
| Revision information | Supports document control. |
SOPs should be maintained under the laboratory's document-control system where applicable.
Roles and Responsibilities
Standardized workflows are more effective when responsibilities are clearly defined.
Personnel should understand which activities they are authorized and trained to perform and which records they are expected to complete.
Responsibilities May Include
- Performing assigned workflow steps
- Verifying material or sample identity
- Recording required information
- Following applicable SOPs
- Reporting deviations
- Maintaining appropriate storage conditions
- Escalating unexpected conditions
Clear responsibilities help prevent important workflow steps from being overlooked.
Material Identification and Verification
Correct material identification should be incorporated into workflows where laboratory materials are received, transferred, prepared or used.
Identification can include product or material name, lot or batch number, sample identifier and other information required by the laboratory.
See Laboratory Vial Label Verification and Laboratory Lot Number Documentation.
Receiving and Inspection Workflows
Incoming materials can be incorporated into a standardized receiving workflow that establishes how packages are inspected, identified, documented and accepted into inventory.
| Receiving Step | Purpose |
|---|---|
| Receive shipment | Establishes the beginning of the receiving process. |
| Inspect packaging | Identifies visible damage or unexpected conditions. |
| Verify material | Confirms the received material matches the expected item. |
| Verify lot information | Supports material traceability. |
| Review documentation | Confirms relevant records are available. |
| Record discrepancies | Creates a record of unexpected conditions. |
| Assign disposition | Determines whether the material is accepted, quarantined or otherwise handled. |
See Laboratory Packaging Inspection and Receiving Laboratory Materials.
Sample and Material Preparation
Preparation steps should be standardized when differences in preparation could influence laboratory results or material handling.
The workflow should identify relevant preparation requirements, equipment, sequence and documentation.
Preparation Controls May Include
- Confirming material identity
- Using appropriate equipment
- Following defined preparation steps
- Recording relevant preparation information
- Controlling environmental conditions where required
- Maintaining appropriate sample identification
- Documenting deviations
Standardized preparation helps reduce differences between personnel and experimental runs.
Handling and Contamination Control
Laboratory workflows should incorporate appropriate controls for handling and contamination prevention.
The exact controls depend on the material, laboratory environment and analytical purpose.
Workflow Controls Can Include
- Hand hygiene
- Clean workspace preparation
- Appropriate equipment handling
- Controlled material movement
- Separation of incompatible workflows
- Appropriate container handling
- Defined cleaning procedures
- Documentation of relevant contamination events
See Laboratory Aseptic Technique, Hand Hygiene in Laboratory Workflows and Clean Laboratory Workspace Preparation.
Storage and Environmental Controls
Storage requirements should be incorporated into workflows when temperature, light, moisture or other environmental conditions are relevant to material integrity.
A standardized storage workflow can define where materials are placed, how they are identified and what information should be recorded.
| Storage Control | Purpose |
|---|---|
| Defined storage location | Supports inventory traceability. |
| Storage condition | Maintains conditions appropriate to the material requirements. |
| Inventory status | Distinguishes approved, quarantined or other material states. |
| Lot tracking | Maintains material traceability. |
| Storage logs | Document relevant environmental or inventory information. |
See Laboratory Storage Logs and Laboratory Inventory Management by Lot and Batch.
Workflow Documentation
Documentation provides evidence that defined laboratory workflows were followed and allows important events to be reconstructed.
| Documentation Type | Example Purpose |
|---|---|
| Sample records | Track sample identity and history. |
| Material records | Track laboratory materials and lots. |
| Storage records | Document relevant storage information. |
| Workflow logs | Record completion of defined process steps. |
| Deviation records | Document departures from established procedures. |
| Training records | Document personnel training where applicable. |
Documentation should be clear, contemporaneous and consistent with the laboratory's applicable quality system.
Deviation Management
A standardized workflow should define what happens when an expected process cannot be followed.
Examples can include equipment problems, missing materials, unexpected sample conditions, storage excursions or procedural errors.
Basic Deviation Workflow
- Identify the deviation.
- Document the relevant facts.
- Protect affected materials or samples when necessary.
- Notify the appropriate personnel.
- Evaluate potential impact.
- Determine the appropriate disposition or corrective action.
- Document the resolution.
A deviation should not simply be ignored because the workflow was otherwise completed.
Personnel Training and Standardized Workflows
Personnel training is an important component of workflow standardization. A documented procedure is most effective when personnel understand how and when it should be applied.
Training may include instruction on relevant SOPs, equipment, documentation requirements, contamination controls and deviation reporting.
Training requirements should be appropriate to the personnel's assigned responsibilities.
Workflow Review and Continuous Improvement
Laboratory workflows should be reviewed periodically or when changes in equipment, materials, methods or laboratory requirements occur.
Workflow Review Questions
- Are all required steps clearly defined?
- Are responsibilities clear?
- Are important quality-control checkpoints included?
- Are records complete and understandable?
- Are recurring deviations occurring?
- Have laboratory methods or materials changed?
- Can unnecessary process variation be reduced?
Workflow improvement should preserve necessary quality controls while reducing unnecessary complexity where appropriate.
Standardized Workflows and Research Reproducibility
Standardized laboratory workflows can contribute to research reproducibility by reducing avoidable differences in how samples and materials are handled.
When procedures, preparation steps, storage conditions and documentation are consistent, researchers have a clearer basis for comparing results across experiments.
Standardization cannot eliminate every source of experimental variation, but it can reduce variation caused by inconsistent execution of routine laboratory processes.
Common Problems With Laboratory Workflows
Undefined Process Steps
When important steps are not documented, personnel may perform the same activity differently.
Inconsistent Documentation
Incomplete or inconsistent records can reduce traceability and make investigations more difficult.
Unclear Responsibilities
If ownership of a workflow step is unclear, important checks may be missed.
Outdated Procedures
Procedures that do not reflect current equipment, materials or laboratory practices can create unnecessary risk.
Insufficient Training
Personnel may not apply a workflow consistently if they have not been appropriately trained.
Failure to Manage Deviations
Unrecorded departures from established workflows can make it difficult to evaluate their potential impact.
Overly Complex Workflows
A workflow that contains unnecessary steps can increase the opportunity for mistakes and reduce practical compliance.
Standardized Laboratory Workflow Checklist
| Workflow Practice | Check |
|---|---|
| Define the purpose and scope of the workflow. | ☐ |
| Document important process steps. | ☐ |
| Define personnel responsibilities. | ☐ |
| Verify material or sample identity. | ☐ |
| Include appropriate quality-control checkpoints. | ☐ |
| Define required documentation. | ☐ |
| Establish appropriate storage controls. | ☐ |
| Include contamination-control measures where appropriate. | ☐ |
| Define how deviations are reported. | ☐ |
| Train relevant personnel. | ☐ |
| Maintain document revision control. | ☐ |
| Review workflows periodically. | ☐ |
| Evaluate recurring deviations and improvement opportunities. | ☐ |
| Maintain records that support traceability. | ☐ |
Build Consistent Laboratory Workflows
Well-defined laboratory workflows help connect material control, sample handling, storage, documentation and quality practices into a consistent process.
Explore BacScienceStandardization as Part of Laboratory Quality Management
Standardized workflows provide structure for recurring laboratory activities and help laboratories establish consistent expectations for personnel, materials, documentation and quality-control checkpoints.
The most effective workflows are sufficiently detailed to control important sources of variation while remaining practical for routine laboratory use.
Workflow requirements should be developed according to the laboratory's activities, applicable analytical methods, material characteristics and quality-management requirements.
Frequently Asked Questions About Standardized Laboratory Workflows
What are standardized laboratory workflows?
Standardized laboratory workflows are documented, repeatable sequences of activities designed to ensure that laboratory processes are performed consistently according to defined requirements.
Why are standardized workflows important?
They can reduce avoidable process variation, improve traceability, support training and contribute to more reproducible laboratory work.
What is included in a standardized laboratory workflow?
A workflow may include defined process steps, responsibilities, material identification, quality-control checkpoints, documentation requirements, storage controls and deviation procedures.
What is the role of an SOP?
An SOP provides documented instructions for performing a defined laboratory activity consistently and helps establish clear expectations for personnel.
Can standardized workflows improve research reproducibility?
Yes. Consistent execution of routine laboratory activities can reduce avoidable differences between experimental runs and make results easier to compare.
Should laboratory workflows include deviation procedures?
Yes. A defined deviation process helps personnel document and appropriately evaluate situations in which an established workflow cannot be followed.
How often should laboratory workflows be reviewed?
Review frequency depends on the laboratory's quality system and the nature of the workflow. Procedures should also be reviewed when significant methods, equipment, materials or requirements change.
Why is documentation important in standardized workflows?
Documentation provides evidence of completed activities and supports traceability, investigations and evaluation of deviations.
Do standardized workflows eliminate laboratory variation?
No. They can reduce variation associated with inconsistent execution, but they cannot eliminate all biological, chemical, instrumental or experimental sources of variability.
Who should follow standardized laboratory workflows?
Personnel should follow the workflows applicable to their assigned laboratory responsibilities and training.
Related Research
- Laboratory Documentation Best Practices
- Laboratory Sample Integrity
- Laboratory Vial Handling
- Laboratory Aseptic Technique
- Clean Laboratory Workspace Preparation
- Hand Hygiene in Laboratory Workflows
- Sources of Laboratory Contamination
- Laboratory Cross-Contamination Prevention
- Receiving Laboratory Materials
- Laboratory Packaging Inspection
- Laboratory Inventory Management by Lot and Batch
- Material Quality and Research Reproducibility
Scientific and Quality References
- International Organization for Standardization. ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories.
- World Health Organization. Laboratory Quality Management System guidance.
- U.S. Food and Drug Administration. Laboratory quality systems and data integrity guidance.
- National Academies of Sciences, Engineering, and Medicine. Reproducibility and Replicability in Science.