research-lab-000-work-order-basics-docx

PURPOSE

A Work Order (WO) is a Change Control record (or Change record).
This can be applied to Regulatory (Reg) or Non-Regulatory (Non-reg) changes.

Every action to a Validated system, or Approved Document associated to a validated system (including systems undergoing Validation, or being designed as a validated system) must have a Change Record.

Typically - there will be a Master WO with multiple WOs linked.
Each linked WO is to address a Task that is logically independant.
See appendix A.

Work Orders come from multiple sources:

1) Automation - Preventive Maintenance or Calibration programs (PM) - Annually, Quarterly, etc. generated by a system being enrolled in a PM program.

2) External - Vendor related - created for Vendor actions (locally or remotely).

3) Manual - Created for changes determined NOT part of an established program (Ad-Hoc - as needed).

Sections of WO (included information)
Each of these data points in the WO should Link to that sub-section which includes all information available/needed for execution of the WO.

1) Originator of WO (program, person, company, etc.)
2) Item to change (device, computer, system, document)
3) Summary of change (task)
4) Detail of Task(s) (example: ticketing to remove physical items from Production Status, replace workstation, update WI and/or Asset Mgt. info). Typically - company specific.
5) Assigner (who determines to whom the WO is assigned)
6) Assignee (individual or team)
7) Job Plan (**1)
8) Schedule - any info regarding schedule (**2)
9) Priority
10) Minimum requirements - multi-level* (multiple persons, tools/equipment, materials, etc)
'Minimum' may be a specific info-set or info attached to each level*
11) Review and Approval by System Owner/QA & additional individuals where required. (21CFRp part11)

Sections of Work Order system that WO will draw on (pre-entered):

A) Assets - Devices. Computers. Material parts (replacements).(linked to Asset Mgt system?)
B) Tools - Basic and specialized tools.
C) Experience - specific experience needed for specific tasks w/Rating (people)
D) Persons - people have Experience (rated)
E) Schedule - after an activity is completed - the Time is noted.
This is used as estimate for future assignments and CRITICAL for scheduling availability of
1) TOOLS, 2) EXPRIENCE, 3) PERSONS (each has COST directly applying to dept. budgets.)

**1 Job Plan - a) Description of how to execute the task.
Includes required: Tools, Experience, Persons (1, 2, 10, 1+Vendor, etc.),
DEPENDANCIES (inc. previous steps completed),
Work Instructions: Detailed info on what to do entered by the people executing the task.
May include: Account credentials on device/computer (Admin, Vendor, Superuser, User).

**2 Schedule. Expected Start, End, total, gaps (availability, business schedule),
ACTUALS (for Billing), Vendors.

Appendix A
Examples of Master WO plus linked WOs.

Master:
Upgrade Labaratory instrument's Computer workstation from Windows10 to Windows11.
Assigned to System owner.

Linked WOs:
1. Ticketing to remove system (instrument(s), computer) from Production.
2. IT: create new Windows11 workstation (typically from specified baseline Image) and physically replace Windows10 machine (or perform upgrade on current machine Win10 >> Win11)
3. Vendor installs necessary instrument application into Win11 machine (provides IQ/OQ).
4. Configuration of Win11 box to meet Laboratory requirements based on application, and adding company preferred patrhs to data store (local on Win11 + non-local backup).
This WO may include support to reach system Validation with clean up of test accounts/data, capture of new Golden Image (for that instrument/system), and updates to associated Work Instructions.
5. User account setup on new Win11 and instruments (per approved requests).
6. Deprecate Win10 machine (required from Validation lifecycle) with computer wiped and returned to stock (to Asset mgt.) or disposed (to electronic recycling storage).