Laboratory operations process templates

Sample lifecycle

The sample lifecycle is everything a laboratory does to a sample other than test it: collect it against a request, move it, receive and accession it, label and store it, keep it for as long as a retention basis says, and dispose of it under a recorded authorisation. This family orders eight templates in the sequence a sample passes through them; chain of custody, rejection, aliquoting, inventory and stability pulls apply at points along the way.

1. Sample collection process flowchart

   An editable sample collection workflow for planning a collection, confirming the sample point, recording identification, preparing a handoff and resolving collection discrepancies.

2. Sample transport process flowchart

   An editable sample transport workflow for defining transfer conditions and documents, preparing a package and handoff record, assessing arrival condition, escalating exceptions and closing the transfer record.

3. Sample receipt process flowchart

   A laboratory sample receipt process for delivery checks, documentation review, sample identification, condition assessment, acceptance, accessioning and exception handling.

4. Sample log-in process flowchart

   An editable sample log-in workflow for matching requests to accepted samples, creating an accession record, verifying traceability, correcting entry discrepancies and assigning routing and storage status.

5. Sample labeling process flowchart

   An editable sample labeling workflow for using source records, creating traceable labels, checking label-to-sample matches, correcting discrepancies and recording label status.

6. Sample storage process flowchart

   An editable sample storage workflow for assigning a suitable location, using interim holds when capacity is unavailable, verifying location and status, and updating inventory records.

7. Sample retention process flowchart

   An editable sample retention workflow for reviewing retention records, identifying retained samples, deciding whether an approved disposition can proceed, continuing secure retention and recording the review.

8. Sample disposal process flowchart

   An editable sample disposal workflow for confirming identity and disposition information, segregating material, selecting an authorized disposal route, retaining unresolved samples and recording status.

Also part of this family

• Laboratory sample management process flowchart — A laboratory sample management workflow for receipt, document checks, identification, acceptance, registration, storage and routing to testing or a controlled exception path.
• Sample rejection process flowchart — An editable sample rejection workflow for assessing an exception against local criteria, placing a rejected sample on hold or releasing it to receipt, completing disposition records and resolving documentation gaps.
• Sample chain of custody process flowchart — A sample chain of custody workflow for controlled handoffs, identity and seal checks, signed transfer records, discrepancy handling and an auditable custody trail.
• Laboratory sample review process flowchart — An editable laboratory sample review workflow for checking identity, custody, condition, storage and handling evidence, then assigning status or requesting an evidence-based disposition.
• Sample aliquoting process flowchart — An editable sample aliquoting workflow for verifying source identity and condition, preparing containers and an aliquot plan, checking labels and volumes, resolving discrepancies and recording the result.
• Sample inventory process flowchart — An editable sample inventory workflow for comparing item, location and status with records, assessing availability and condition, investigating discrepancies, applying approved holds or adjustments and recording review results.

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Laboratory testing

Laboratory testing is the part of the laboratory that produces a result: an assigned work item is prepared, run under a controlled method with its readiness and suitability checks, and handed on as a result package for review. This family orders four templates in the sequence a run passes through them, and gathers the technique-specific and purpose-specific variants and the in-run controls around them.

1. Laboratory worklist process flowchart

   An editable laboratory worklist workflow for checking request completeness and priority, assigning qualified analysts, balancing capacity and resources, escalating conflicts and tracking each item to its next action.

2. Sample preparation process flowchart

   An editable sample preparation workflow for confirming instructions and sample status, preparing materials, checking the preparation record, correcting issues and handing prepared samples to testing.

3. Analytical testing process flowchart

   An editable analytical testing workflow for confirming method scope, preparing samples and standards, checking readiness, executing a sequence, reviewing raw data and resolving readiness failures.

4. Test method execution process flowchart

   An editable test method execution workflow for confirming an approved instruction, setting up work, checking readiness, capturing raw data, reviewing the result package and escalating unavailable resources.

Also part of this family

• Laboratory testing process flowchart — A laboratory testing workflow covering method selection, equipment and reagent readiness, sample preparation, system suitability, quality control, result review and reporting.
• Chromatography testing process flowchart — An editable chromatography testing workflow for confirming method, sequence and samples, preparing the system, checking suitability, resolving a failed suitability check and reviewing chromatographic data.
• Dissolution testing process flowchart — An editable dissolution testing workflow for confirming the method and sample configuration, preparing apparatus and materials, checking setup, resolving issues, recording observations and reviewing the result record.
• Microbiological testing process flowchart — An editable microbiological testing workflow for confirming sample and method information, preparing test materials, checking controls and equipment, recording observations and resolving setup failures.
• Raw material testing process flowchart — An editable raw material testing workflow for confirming material identity and records, planning required checks, preparing samples and controls, resolving invalid work and providing reviewed status input.
• Finished product testing process flowchart — An editable finished product testing workflow for confirming product and batch information, planning test work, checking controls and data review, investigating issues and sending reviewed results to disposition.

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Laboratory data review

Laboratory data review is the gate between a result that exists and a result that can be used. A reviewer confirms the record is complete, attributable and consistent, the notebook entry is checked as the record of the work, the report is prepared from approved data and authorised, and a Certificate of Analysis carries the result outside the laboratory. This family orders those four steps and adds the specialist reviews behind them.

1. Laboratory data review process flowchart

   A laboratory data review workflow for completeness and traceability checks, calculation verification, discrepancy assessment, corrections, reviewer approval and a controlled result record.

2. Laboratory notebook review process flowchart

   A laboratory notebook review process chart for screening entries, checking calculations and attachments, resolving queries, escalating record concerns and signing the review.

3. Laboratory report approval process flowchart

   A laboratory report approval process chart for clarifying the request, preparing reports from approved data, resolving technical issues, obtaining authorization and recording distribution.

4. Certificate of Analysis (CoA) process flowchart

   A Certificate of Analysis process for compiling approved results, confirming reportable information, resolving discrepancies, authorized approval, controlled issuance and record retention.

Also part of this family

• Chromatographic data review process flowchart — A chromatographic data review process chart for confirming run context, reviewing integration and audit trails, resolving processing queries, assessing results and approving the review record.
• Laboratory data integrity review process flowchart — A laboratory data integrity review process chart for scoping affected records, assessing provenance and audit-trail evidence, containing concerns, assigning follow-up and documenting disposition.
• Laboratory document control process flowchart — A laboratory document control process chart for defining document ownership, drafting revisions, resolving technical and approval comments, and publishing the current controlled version.

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Laboratory investigations

A laboratory investigation is what happens when a result, an event or a record cannot be taken at face value: an out-of-specification result, a departure from the procedure, a nonconformance, an instrument failure with data impact. This family orders six templates from the first triage of a reported concern to the quality-reviewed closure of the corrective action, and gathers the other routes that feed the same chain.

1. Quality event triage process flowchart

   An editable quality event triage workflow for logging facts, applying immediate safeguards, classifying an event, routing investigation or correction work and escalating material impact.

2. Out-of-specification (OOS) investigation process

   An OOS investigation workflow for securing data and samples, initial laboratory review, assignable-cause assessment, validity decisions, expanded investigation, impact assessment and CAPA.

3. Laboratory root cause analysis process flowchart

   An editable laboratory root cause analysis workflow for defining a problem, mapping contributing factors, testing evidence, developing corrective options and approving an action handoff.

4. Laboratory CAPA process flowchart

   A laboratory CAPA workflow for problem definition, containment, root-cause analysis, corrective-action planning, implementation, effectiveness checks, QA review and closure.

5. Corrective action effectiveness process flowchart

   An editable corrective action effectiveness workflow for defining the intended outcome, reviewing follow-up evidence, identifying recurrence or shortfall, revising action plans and recording review results.

6. Laboratory investigation closure process flowchart

   An editable laboratory investigation closure workflow for compiling evidence, reviewing impact and action status, resolving open risks, obtaining quality acceptance and updating the closure record.

Also part of this family

• Laboratory investigation process flowchart — A laboratory investigation workflow for securing evidence, defining the event, assessing an assignable cause, determining data validity, impact assessment, corrective action and closure.
• Laboratory deviation investigation process flowchart — An editable laboratory deviation investigation workflow for containment, evidence gathering, cause assessment, impact review, CAPA or escalation follow-up, and quality-approved closure.
• Laboratory nonconformance process flowchart — A laboratory nonconformance workflow for containment, classification, correction, investigation, sample or data impact assessment, corrective action and quality-approved closure.
• Laboratory incident management process flowchart — An editable laboratory incident management workflow for protecting people, work and evidence, assessing impact, routing investigations, escalating leadership decisions and recording closeout.
• Laboratory escalation process flowchart — An editable laboratory escalation workflow for recording an issue, controlling immediate risk, assessing urgency and scope, involving leadership or specialist groups, and communicating accountable next steps.

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Analytical method lifecycle

An analytical method has a life of its own, separate from any sample it is applied to: it is developed for an intended use, validated against a protocol, verified or transferred into each laboratory that will run it, changed under control and eventually reviewed for retirement. This family orders six templates in that sequence and adds the periodic review that decides whether a method continues, is improved, restricted or retired.

1. Analytical method development process flowchart

   An analytical method development process chart for defining intended use, selecting conditions, iterating studies, reviewing practicality, escalating gaps and issuing a controlled method.

2. Method validation protocol process flowchart

   A method validation protocol process chart for defining scope, drafting study instructions, resolving reviewer comments, approving execution readiness and issuing a controlled protocol.

3. Analytical method validation process flowchart

   An analytical method validation workflow for protocol approval, readiness, execution, acceptance-criteria review, deviations, validation reporting, approval and controlled implementation.

4. Analytical method verification process flowchart

   An analytical method verification process chart for confirming local scope, planning evidence, repeating justified work, resolving open concerns, approving local use and training users.

5. Method transfer process flowchart

   A method transfer workflow using sending laboratory, receiving laboratory, method owner and quality roles for protocol preparation, readiness, comparative testing, deviations, approval and implementation.

6. Analytical method change control process flowchart

   An analytical method change control process chart for clarifying changes, assessing method and data impact, completing needed work, resolving approval concerns and implementing a controlled update.

Also part of this family

• Analytical method lifecycle process flowchart — An analytical method lifecycle process chart for reviewing method status, performance, changes and issues, planning action, escalating concerns and updating controlled records.

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Laboratory equipment

Laboratory equipment is qualified for an intended use, registered, labelled with its current status, logged at every use, cleaned, maintained, calibrated on a recall date and finally retired without losing its history. This family orders eight templates along that life, and adds the reactive pair that runs when an instrument fails: breakdown and return to service.

1. Equipment qualification process flowchart

   An equipment qualification workflow for defining intended use, planning evidence, checking installation, executing qualification, resolving gaps, authorizing status and recording limitations.

2. Laboratory equipment inventory process flowchart

   A laboratory equipment inventory workflow for defining count scope, locating assets, comparing identifiers and status, investigating discrepancies, authorizing changes and updating the equipment register.

3. Equipment status labeling process flowchart

   An equipment status labeling workflow for confirming identity and status basis, selecting usable label information, applying and verifying labels, resolving discrepancies and updating the equipment register.

4. Equipment use log process flowchart

   An equipment use log workflow for confirming asset status and user authorization, recording planned activity and observations, escalating events, reconciling missing details and updating history.

5. Laboratory equipment cleaning process flowchart

   A laboratory equipment cleaning workflow for confirming method and status, preparing equipment, performing cleaning, checking condition and records, rework, readiness review and log updates.

6. Laboratory equipment maintenance process flowchart

   A laboratory equipment maintenance workflow for scheduling service, managing availability, confirming instructions and parts, completing work, functional checks, escalation and maintenance records.

7. Laboratory equipment calibration process flowchart

   A laboratory equipment calibration workflow for due-date recall, out-of-service control, as-found checks, calibration, out-of-tolerance impact assessment, records and release.

8. Laboratory equipment retirement process flowchart

   A laboratory equipment retirement workflow for confirming the asset and reason, reviewing history and data, protecting ongoing work, authorizing transfer, disposal or archival handoff and recording closure.

Also part of this family

• Laboratory equipment breakdown process flowchart — A laboratory equipment breakdown workflow for safe shutdown, out-of-service control, repair triage, sample and data impact assessment, verification and controlled return to service.
• Equipment return-to-service process flowchart — An equipment return-to-service workflow for repaired or maintained laboratory equipment, readiness checks, calibration or verification, approval, status labeling and logbook updates.

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Reagents and standards

Reagents and reference standards are the materials a result is made from, and a result is only as reliable as the lot, the label and the expiry date behind it. This family orders seven reagent templates from qualifying a material through receipt, labelling, stock, preparation and expiry to disposal, and adds the reference standard pair and the overview that covers the whole cycle.

1. Reagent qualification process flowchart

   A reagent qualification workflow for defining intended use and source, planning evidence review, evaluating a material or lot, approving, holding or rejecting it and recording follow-up.

2. Reagent receipt process flowchart

   A reagent receipt workflow for checking a delivery against the request, inspecting condition and evidence, assigning status, handling holds and recording the receipt outcome.

3. Reagent labeling process flowchart

   A reagent labeling workflow for confirming identity and status evidence, selecting label information, approving and applying labels, correcting mismatches and updating the status record.

4. Reagent inventory process flowchart

   A reagent inventory workflow for comparing stock records with physical material, investigating discrepancies, assessing availability, issuing or replenishing stock and recording follow-up.

5. Reagent preparation process flowchart

   A reagent preparation workflow for confirming approved instructions and inputs, checking readiness, recording preparation, verifying the result, assigning status and investigating exceptions.

6. Reagent expiry management process flowchart

   A reagent expiry management workflow for reviewing identity and date records, assessing current condition, managing near-expiry material, segregating unsuitable stock and recording follow-up.

7. Reagent disposal process flowchart

   A reagent disposal workflow for confirming identity and status records, segregating material, choosing an authorized route, correcting transfer discrepancies and recording final or pending disposition.

Also part of this family

• Laboratory reagent management process flowchart — A laboratory reagent management workflow for approved material availability, receipt checks, expiry review, preparation, lot records, labeling, verification, storage and disposal.
• Reference standard qualification process flowchart — A reference standard qualification workflow for defining identity, source and intended use, reviewing evidence, evaluating a candidate, approving or holding it and recording qualification conditions.
• Reference standard management process flowchart — A reference standard management workflow for retrieving an approved standard, checking identity and status, handling unsuitable material, completing added checks and updating the standard record.

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Environmental monitoring

Environmental monitoring is the routine collection of readings and observations about the spaces, utilities and storage conditions a laboratory's work depends on, and the review that turns a reading into a decision. This family orders three templates from routine monitoring through trend review to excursion handling, and adds the cleanroom, water, temperature and humidity variants.

1. Environmental monitoring process flowchart

   An environmental monitoring workflow for planning observations, collecting contextual evidence, reviewing signals and trends, assigning follow-up, escalating exceptions and closing the review.

2. Environmental monitoring trend review process flowchart

   An environmental monitoring trend review workflow for confirming data scope, compiling context, assessing recurring signals, documenting no-action rationale, approving action plans and escalating unresolved patterns.

3. Environmental monitoring excursion process flowchart

   An environmental monitoring excursion workflow for verifying a signal, protecting affected work, identifying the area, assessing context and impact, approving disposition and escalating unresolved cases.

Also part of this family

• Cleanroom environmental monitoring process flowchart — A cleanroom environmental monitoring workflow for confirming the sampling plan and area status, collecting observations, evaluating patterns, assigning follow-up and escalating findings for responsible review.
• Laboratory water monitoring process flowchart — A laboratory water monitoring workflow for confirming a sampling point and method, collecting source context, evaluating results and patterns, assigning follow-up and escalating unresolved findings.
• Laboratory temperature excursion process flowchart — A laboratory temperature excursion workflow for verifying the reading, protecting samples and reagents, determining duration and magnitude, impact assessment, disposition, corrective action and closure.
• Laboratory humidity excursion process flowchart — A laboratory humidity excursion workflow for verifying a reading, protecting affected work, identifying the area, assessing duration and context, reviewing disposition and escalating unresolved cases.

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Laboratory quality system

1. Laboratory audit preparation process flowchart

   An editable laboratory audit preparation workflow for confirming scope and criteria, collecting controlled evidence, addressing readiness gaps, reviewing the audit pack and briefing participants.

2. Laboratory internal audit process flowchart

   An editable laboratory internal audit workflow for planning an independent review, examining records and activities, documenting findings, agreeing response ownership and approving follow-up.

3. Laboratory change control process flowchart

   An editable laboratory change control workflow for defining a proposed change, assessing method and data impact, planning evaluation, implementing approved updates and recording the outcome.

Analyst training

An analyst is authorised to perform a method on evidence, not on attendance: training is assigned, practice is supervised, competency is observed against defined criteria, the authorisation decision fixes a scope, and the training record shows what supports the current status. This family orders five templates along that path and adds the route for a gap found later.

1. Laboratory analyst training process flowchart

   A laboratory analyst training workflow that separates assigned training, supervised practice, demonstrated competency, method authorization, training records and requalification monitoring.

2. Laboratory analyst qualification process flowchart

   A laboratory analyst qualification workflow for confirming method scope and prerequisites, assigning learning and supervised practice, assessing performance, reviewing evidence and escalating an unaccepted decision.

3. Analyst competency assessment process flowchart

   An analyst competency assessment workflow for confirming current criteria and method versions, observing performance, recording evidence, providing focused coaching and escalating unaccepted competency dispositions.

4. Analyst authorization process flowchart

   An analyst authorization workflow for confirming method scope and prerequisites, reviewing training and qualification evidence, defining authorized scope, assigning remediation and escalating unaccepted decisions.

5. Laboratory training record process flowchart

   A laboratory training record workflow for verifying attributable source evidence, reviewing attendance and assessment records, correcting discrepancies, updating controlled records and escalating unaccepted updates.

Also part of this family

• Laboratory training gap process flowchart — A laboratory training gap workflow for understanding affected work, assessing current evidence, applying local restrictions or supervision, approving remediation plans and escalating unresolved gaps.

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Laboratory safety

Laboratory safety splits into what is decided before the work and what happens when it goes wrong. The preventive chain is the risk assessment for an activity, the PPE that assessment requires and the handling of the waste it produces; the reactive routes are spill response, emergency response and the reporting and investigation of a safety incident. There is no single umbrella safety-programme template; the six cover it between them.

1. Laboratory risk assessment process flowchart

   A laboratory risk assessment workflow for clarifying activity scope, identifying hazards and existing controls, assigning further controls or approval, documenting rationale and escalating unaccepted assessments.

2. Laboratory PPE management process flowchart

   A laboratory PPE management workflow for understanding task and hazard context, reviewing availability, fit and condition, resolving gaps, documenting suitability decisions and escalating unaccepted dispositions.

3. Laboratory waste management process flowchart

   A laboratory waste management workflow for identifying waste streams and container status, applying local segregation and labelling procedures, resolving handling issues, documenting traceability and escalating disposition decisions.

Also part of this family

• Laboratory spill response process flowchart — A laboratory spill response workflow for clarifying the material and area status, selecting the applicable site procedure, managing local response or emergency escalation, reviewing follow-up and closing the record.
• Laboratory emergency response process flowchart — A laboratory emergency response workflow for clarifying the situation and local role, activating applicable site arrangements, coordinating support, documenting recovery actions and escalating an unaccepted post-event review.
• Laboratory safety incident process flowchart — A laboratory safety incident workflow for reporting observed hazards, addressing immediate concerns, preserving evidence, deciding investigation needs, documenting corrective actions and escalating unaccepted closure.

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Outsourced testing

Outsourced testing is the set of interfaces a laboratory builds when a test runs somewhere else: deciding what to outsource, qualifying the contract laboratory for a defined scope, handing samples over, reviewing the results that come back and reviewing the arrangement itself. This family orders five templates in that sequence and adds the route for a deviation that happens at the contract laboratory.

1. Laboratory outsourcing process flowchart

   An editable laboratory outsourcing workflow for defining a testing need, deciding whether external sourcing fits, selecting a candidate, agreeing interfaces and activating the arrangement.

2. Contract laboratory qualification process flowchart

   An editable contract laboratory qualification workflow for defining outsourced test scope, assessing capability, resolving gaps, recording authorization and setting review triggers.

3. Sample transfer to contract laboratory process flowchart

   An editable sample transfer workflow for planning an external laboratory handoff, preparing identifiers and records, confirming receipt, resolving issues and tracking follow-up.

4. External laboratory result review process flowchart

   An editable external laboratory result review workflow for checking report scope, obtaining missing context, assessing results, escalating concerns and recording follow-up ownership.

5. Contract laboratory performance review process flowchart

   An editable contract laboratory performance review workflow for collecting service evidence, resolving gaps, assessing concerns, planning action and recording the next review trigger.

Also part of this family

• External laboratory deviation process flowchart — An editable external laboratory deviation workflow for recording the event, checking immediate controls, requesting evidence, assessing impact, escalating actions and tracking closure.

View the sequence