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Standard Operating Procedure[Template]

1. Purpose

To define standardized procedures for configuring, executing, reviewing, approving, and retaining electronic laboratory logs used to document operational activities, equipment maintenance, and routine laboratory tasks using an electronic log management system.

2. Scope

This SOP applies to all laboratory departments utilizing electronic logs for:

  • Equipment and instrument maintenance
  • Operational and safety checks
  • Routine and scheduled laboratory tasks
  • Event-driven or ad hoc documentation

This SOP does not replace laboratory test SOPs, LIS procedures, or clinical result reporting workflows.

3. Responsibilities

Bench Staff

  • Complete assigned electronic log tasks accurately and on time
  • Document results, exceptions, and corrective actions as required
  • Attach supporting documentation when applicable

Supervisors / Section Leads

  • Ensure logs are configured correctly for their department
  • Monitor daily task completion and exceptions
  • Review completed records and initiate corrective actions when needed

Laboratory Managers / QA

  • Approve log structures and major revisions
  • Perform periodic reviews and formal sign-offs
  • Ensure audit readiness and record retention compliance

4. Definitions

(Aligned with system terminology)

  • Log: A defined set of tasks documenting a process or activity
  • Task: An individual action within a log
  • Record / Entry: Evidence created when a task is completed
  • Maintenance Log: Recurring or date-anchored maintenance tasks
  • Checklist / Task List: One-time or non-recurring assigned tasks
  • Sheet Log: Event-driven entries organized in cycles
  • Ad Hoc Task: Out-of-schedule task documented with justification
  • Lead Time: Period before due date when a task becomes “Due Soon”
  • Overdue Time: Grace period after due date before task is overdue

5. System Setup and Configuration

5.1 Configure Operational Mode and Shifts

Purpose:
To ensure electronic logs populate tasks in alignment with laboratory operating days and shift structure.

Procedure:

      1. Log in with administrative or site-level permissions.
      2. Navigate to Site Settings.
      3. Select Operational Mode.
      4. Choose:
        • 5-Day Lab if routine tasks should not generate on weekends, or
        • 7-Day Lab if daily tasks must populate every calendar day.
      5. Save changes.

Multi-Shift Configuration (if applicable):

      1. Navigate to Site Settings → Manage Shifts.
      2. Select Add Shift.
      3. Enter:
        • Shift name (e.g., Day, Evening, Night)
        • Start time and end time
        • Display order
      4. If prompted about overlapping shifts, review and acknowledge overlap.
      5. Save the shift configuration.

Expected Outcome:
Tasks will populate based on operational days and appear under the appropriate shift workload views on the dashboard.

5.2 Instrument Setup

Purpose:
To ensure all equipment requiring documentation is available for log creation, association, and reporting.

Procedure:

      1. Navigate to Instruments → Add New Instrument.
      2. Enter the instrument name exactly as referenced in lab SOPs.
      3. Enter required identifiers:
        • Serial number (required)
        • Model number (if available)
      4. Select or add:
        • Manufacturer
        • Device type (e.g., analyzer, centrifuge, freezer)
      5. Assign the instrument to the correct department.
      6. Enter the in-use date if known.
      7. Upload an instrument image if available (recommended).
      8. Select Create Instrument.

Expected Outcome:
The instrument becomes selectable when creating logs and is available for filtering, reporting, and audits.

5.3 Frequency Configuration

Purpose:
To define how often tasks repeat and how compliance status is calculated.

Procedure:

      1. Navigate to Configure Frequencies → Create New Frequency.
      2. Enter a frequency name (e.g., Daily, Weekly).
      3. Define the period (e.g., 1 day, 7 days).
      4. Set:
        • Lead Time – when a task transitions to “Due Soon.”
        • Overdue Time – when a task becomes overdue after the due time.
      5. Save the frequency.

Important Notes:

      • Lead time and overdue time directly control dashboard colors and alerts.
      • Frequencies should align with written SOP expectations.

5.4 Notification Configuration

Purpose:
To ensure appropriate staff are alerted to upcoming and missed tasks.

Procedure:

      1. Navigate to Notifications → Delivery Matrix.
      2. Select the department.
      3. Choose the notification type:
        • Due Soon
        • Overdue / Missed Task
      4. Select delivery method:
        • Dashboard
        • Email
        • Both
      5. Assign notifications to one or more users.
      6. Optionally save as a reusable profile.
      7. Confirm assignments in the Notification Overview.

Expected Outcome:
Assigned staff receive alerts based on task status and department ownership.

6. Log Creation and Activation

6.1 Log Creation – Maintenance Logs

Purpose:
To create recurring or scheduled maintenance documentation.

Procedure:

      1. Navigate to Create Log.
      2. Select Maintenance Log.
      3. Enter:
        • Log name
        • Version name (defaults to V1 if blank)
        • Department
        • Instrument (if applicable)
      4. Select Add Task for each task required.

Task Configuration Steps:

      1. Enter task name.
      2. Select schedule type:
        • Frequency-based (automatic recurrence)
        • Date-anchored (manual next due date)
      3. Set initial due date and time.
      4. Select result type (numeric, pass/fail, dropdown, etc.).
      5. Enter task instructions (strongly recommended).
      6. Assign shift if applicable.
      7. Reference SOP or policy number if available.
      8. Save the task.
      9. Once all tasks are added:
        • Select Save as Draft (if not ready), or
        • Select Save and Publish to activate.

Expected Outcome:
Active logs generate tasks automatically and are visible to staff.

6.2 Checklist / Task List Logs

Procedure:

      1. Select Checklist / Task List as log type.
      2. Enter log details.
      3. Add tasks (default frequency = “As Needed”).
      4. Assign:
        • Whole lab, group, or individual
      5. Save and publish.

6.3 Sheet Logs (Event-Driven Logs)

Procedure:

      1. Select Sheet Log.
      2. Enter log details.
      3. Select cycle (daily, weekly, monthly, etc.).
      4. Select the custom log button to create a log
      5. Define:
        • Header fields (cycle-level data)
        • Row fields (repeatable entries)
      6. Configure whether header changes trigger a new cycle.
      7. Save and publish.

7. Task Execution and Documentation

7.1 Completing a Task

Procedure:

      1. Access tasks via:
        • Dashboard
        • View Logs
      2. Select the log and locate the task.
      3. Enter required results and select Complete.
      4. Add comments or corrective actions if applicable.
      5. Attach documents or images if required.
      6. Select Save

Expected Outcome:
A permanent record is created with the user, date/time, and result.

7.2 Exception Handling

Procedure:

      1. If a task cannot be completed, select Other Actions.
      2. Choose the appropriate exception:
        • Not performed
        • Unable to perform
        • Not applicable
        • Not in use
      3. Enter a mandatory explanation.
      4. Submit.

7.3 Error Logging

Procedure:

      1. From the task entry screen, select Log Error.
      2. Enter:
        • Error date/time
        • Description
        • Corrective action
      3. Indicate:
        • Whether issue was resolved internally
        • Whether service was called
      4. Enter service reference number if applicable.
      5. Save.

7.4 Ad Hoc Tasks

Procedure:

      1. Open the log.
      2. Select Add Ad Hoc Task.
      3. Enter task name.
      4. Select reason.
      5. Complete task as normal.

8. Dashboard Monitoring and Oversight

Procedure for Supervisors:

    1. Open Dashboard daily.
    2. Review:
      • Today’s tasks
      • Overdue tasks
      • Upcoming tasks
    3. Review shift workload distribution.
    4. Investigate red or yellow indicators immediately.
    5. Follow up with staff as needed.

9. Review and Sign-Off

9.1 Performing Reviews

Procedure:

      1. Navigate to Reports.
      2. Apply filters and date range.
      3. Review summary metrics.
      4. Open flagged or failed records.
      5. Add review comments and corrective actions if required.

9.2 Sign-Off

Procedure:

      1. Select Sign Off.
      2. Choose role/job title.
      3. Enter review comments if applicable.
      4. Authenticate using assigned credentials.
      5. Complete sign-off.

10. Log Revision and Change Control

10.1 Minor Revisions

      1. Go to View Logs
      2. Locate log → Action menu → Revise.
      3. Make minor edits.
      4. Select Update only, no new version.
      5. Save.

10.2 Major Revisions

      1. Revise log.
      2. Enter the new version number and reason for the update.
      3. Make changes.
      4. Select Save changes and create a new version.
      5. Publish a new version.

10.3 Retiring Logs

      1. Go to view Log
      2. Locate log → Action menu (3 dots) → Retire.
      3. Confirm retirement.