Standard operating procedure · RD3B · Research & Development
Protocol Deviation
Transactional procedure owned by Experiment Design in Research & Development. 5 numbered steps, 1 of them a person deciding and 4 of them agent work … more
Procedure code
RD3B
Transactional
Rule versions in force
v1.6 · v1.3
2 governing rules stacked over it
In force since
2025-03-26
Earliest effective date across those rules
Last reviewed
2026-07-31
Latest review date across those rules
Rules approved by
1
Director, Research Methods
Rule health
2/2
0 under review · 0 superseded
There is no document register behind this header. The version, the dates and the approver names are read off the governing rules this procedure runs inside, which is the closest thing the estate holds to a document control record. Nobody wrote these procedures. There is no document library behind this page and no Word file anywhere in the estate. Every procedure below is generated from rows this platform already holds: the line and its ordered stations, the owning team and the person accountable for it, the policy items bound to that team, and the governance gates seeded against the function. The steps, the owners, the gates, the approvers, the dwell times and the volumes are read straight off those rows. The sentences that join them together are generated. Read a procedure as the estate describing itself, not as a document somebody signed.
Purpose and scope
What this procedure is for and where it stops
To run protocol deviation to one repeatable standard inside Experiment Design, part of Research & Development. more
Entry condition
Runs transactional. Starts when a request lands in the queue.
Exit condition
The unit clears document. more
In scope
- Every unit of protocol deviation raised inside Experiment Design, from the trigger below through to the final step.
- 4 of the 5 steps, which run without a person present.
- 1 decision that stops the line until a named person releases it.
Out of scope
- Anything outside the envelope set by the owning team. It leaves the line at a gate and becomes the named approver's decision.
- Work that belongs to another function. This line records no handoff, so nothing leaves it mid-flow.
- The 2 steps carried on the shared AI GBS spine. They are done for this line but not by this function.
Who owns it
Runs the line
Experiment Design Orchestrator
Accountable person
Director, Research Methods
The end of the escalation path. Above them sits R&D Chief of Staff for the function.
That team’s remit
Owns protocol work end to end inside Research & Development. more
That remit describes the whole team, not this one procedure, so its counts are larger than the ones on this page.
Autonomy
59% now · ceiling 72%
Protocol drafting and power analysis are agentic. more
The procedure, step by step
5 numbered steps · 1 of them stop for a person
A step is one station on the line. more
| No. | Step | Who does it | What happens | System of record | Time on the step | In flight |
|---|---|---|---|---|---|---|
| 01 | Detect GBSgbs | Protocol Drafting Agent | Protocol Drafting Agent performs this step unattended on the shared AI GBS transaction spine, outside the function, inside the envelope its owning team has set, and writes an evidence record naming the actor, the authority it acted under and the digests of what it read and wrote. | Product Lifecycle Management | 1.3 hrsstandard 2.0 hrs | 10 |
| 02 | Classify Agentworkflow | Power Analysis Agent | Power Analysis Agent performs this step unattended at the workflow layer, inside the envelope its owning team has set, and writes an evidence record naming the actor, the authority it acted under and the digests of what it read and wrote. | Product Lifecycle Management | 2.0 hrsstandard 3.6 hrs | 21 |
| 03 | Assess validity impact Agentworkflow | Control Design Agent | Control Design Agent performs this step unattended at the workflow layer, inside the envelope its owning team has set, and writes an evidence record naming the actor, the authority it acted under and the digests of what it read and wrote. | Research Notebook and Experiment Data | 1.7 hrsstandard 3.1 hrs | 8 |
| 04 | Scientist decide HumanpolicyDecision | Director, Research Methods Releases: Director, Research Methods | Work stops. Director, Research Methods reviews what the line has produced and either releases the unit or sends it back. Nothing downstream of this step runs until that decision is made.Holds until: Held for a named human when the unit exceeds the protocol decision envelope, when confidence falls below the floor, or when a policy clause is engaged. | Product Lifecycle Management | 2.4 hrsstandard 4.4 hrs | 9 |
| 05 | Document GBSgbs | Protocol Drafting Agent | Protocol Drafting Agent performs this step unattended on the shared AI GBS transaction spine, outside the function, inside the envelope its owning team has set, and writes an evidence record naming the actor, the authority it acted under and the digests of what it read and wrote. | Product Lifecycle Management | 18 minstandard 30 min | 24 |
The swimlane
The same steps, laid out by who is holding the work
Three lanes: a person deciding, an agent working, and the shared services spine. more
Run the procedure
One unit walked along that swimlane on the happy viable agentified path
Press run and a single unit enters at station 01. Each station takes exactly the dwell this platform records for it and is held by whoever the estate says holds it. more
Nothing has happened yet. more
- The lanes are the recorded lanes. 1 of the 5 stations stop for a person and every one of them still does on this run.
- Every one of the 1 decision is still taken by the person who holds it. The happy path is that each one is released first time, not that it is skipped.
- The owning team is held to a 72% autonomy ceiling and this run sits at 69% unattended, inside it.
- 2 systems are attributed across the stations, and 0 of them are connected. Nothing in this run has been watched executing against a real system of record.
One decision, held by Director, Research Methods. more
- 04 Scientist decide — The last decision on the line. Something on every procedure ends with a person, so this one is never offered.
This is a run, not a forecast. more
Happy means nothing goes wrong: no station raises an exception, no gate sends the unit back, no rework loop fires and nothing sits in a queue between stations. more
The second clock is the allowance. more
A decision may be handed to the agent lane only if two things hold … more
The run reads the station rows only. more
What this run does not model: arrival patterns, contention between procedures for the same person, shift patterns, weekends, learning curves, and the cost of anything. more
Run it again, going wrong
The same unit, the same stations, broken the way the estate already records breaking
This is the same unit on the same stations, breaking. more
No break below was chosen. more
One play head, two tracks, the same scale. The clean run stops when it runs out of stations; the other one keeps going.
As written
5 stations, nothing waiting, nothing sent back
0 min of 7.7 hrs
now Detect · Protocol Drafting Agent · 1.3 hrs
As the ledger has it
the same stations, plus 4 categories the estate already counts
0 min of 23 hrs
now Detect · Protocol Drafting Agent · 1.3 hrs
What breaks, and where it is counted
No break below was chosen. more
What the two runs say together
4 counted categories land on this procedure. more
What this run cannot claim
These breaks are shown together on one unit so the shape of a bad day fits on one screen. more
The separation register records a duty conflict against a sub-function and a named post, not against one procedure. more
Two clocks run. Worked time is the sum of the time the work is actually being done … more
Roles and responsibilities
5 named parties
The responsibility grid is assigned by a rule, not lifted from a chart. more
| Party | RACI | Steps | Duty | Escalates to |
|---|---|---|---|---|
Experiment Design Orchestrator orchestrator | Runs the line | 0 | Sequences this line, holds its timetable and decides what has to surface to a person. more | Raises to Director, Research Methods when a unit falls outside the envelope or confidence drops below the floor. |
Protocol Drafting Agent agent A3% autonomy · ceiling A3% 93% clean · 4% overridden | Responsible | 2 | Runs the repeatable portion of experiment design inside the shared transaction spine at spine cost and spine controls. | Escalates to Director, Research Methods when the unit falls outside the decision envelope or confidence drops below the floor. |
Power Analysis Agent agent A3% autonomy · ceiling A3% 89% clean · 4% overridden | Responsible | 1 | Executes the experiment design step it owns, posts its evidence, and hands the unit to the next stage. | Escalates to Director, Research Methods when the unit falls outside the decision envelope or confidence drops below the floor. |
Control Design Agent agent A2% autonomy · ceiling A2% 92% clean · 14% overridden | Responsible | 1 | Holds the rules that bind every other agent in global process ownership. more | Escalates on any decision that would breach a live policy version, with the clause cited. |
Director, Research Methods person | Accountable and responsible | 1 | Holds 1 decision on this line. more | Accountable to Director, Research Methods for the decisions held here. |
Decision points and escalation
1 places this procedure stops
04 · Scientist decide
2.4 hrsHeld for a named human when the unit exceeds the protocol decision envelope, when confidence falls below the floor, or when a policy clause is engaged.
Director, Research Methods
Handoffs out of this procedure
Nothing leaves this procedure for another function. It completes inside Experiment Design.
The rules this procedure runs inside
2 governing rules
Experiment Design Decision Envelope
activeRD3-POL-200 · envelope · vv1.6
Agents in this lane may act without a human when the protocol sits inside the stated value, risk and confidence envelope. more
Approved by Director, Research Methods · in force 2025-03-26 · reviewed 2026-06-24
Binds Protocol Drafting Agent, Power Analysis Agent, Control Design Agent
EU · UK
Experiment Design Evidence Standard
activeRD3-POL-201 · evidence · vv1.3
Every autonomous decision writes inputs, the rule version applied, the model and prompt version, the output and a reversal path. more
Approved by Director, Research Methods · in force 2026-04-02 · reviewed 2026-07-31
Binds Protocol Drafting Agent, Power Analysis Agent, Control Design Agent
EU · UK · US
Systems this procedure touches
2 named · 0 connected
System attribution is a rule, not a reading. more
| System | Vendor | Domain | Criticality | Steps | Connection |
|---|---|---|---|---|---|
| Product Lifecycle Management | Siemens Teamcenter | engineering | high | 4 | modeled |
| Research Notebook and Experiment Data | Benchling | engineering | medium | 1 | not-connected |
0 of the 2 systems on this procedure is connected to the platform, and none of the twenty-six in the estate register is. 0 of them are marked as taking a write back, which is a property of the system, not a live path from here.
How it performs
End to end
7.7 hrs
Summed from the time each step sits, standard 13.7 hrs — running at 56% of the standard.
Touchless
67%
Agent share
80%
A week
7,292
In flight
72
Effort a week
141 human minutes · 318 agent minutes
Volume multiplied by the time on each step. more
Assurance over this procedure
4 governance gates sit above it
The twenty-four controls and eighteen exception classes in this platform are held at estate level … more
| Gate | What trips it | Who releases it | Clock | Waivable |
|---|---|---|---|---|
Physical experiment authorization approval | Any laboratory experiment involving materials, equipment or subjects | Principal investigator and safety officer | 2 business days | No |
External data acquisition approval | Any new external dataset, license or third-party evidence source | Research governance and Legal | 3 business days | No |
Publication or external disclosure approval | Any material leaving the research boundary, including conference abstracts | CSO and General Counsel | 5 business days | No |
Reproduction sampling oversight | Independent re-derivation of 15% of reported internal results | Reproducibility board | Monthly | No |
Next to it on the same team
Experiment Design
What this document is and is not
These procedures describe the modeled estate. more
Actions
What is waiting on a person
What one procedure document gives you, and what to check before you treat it as the standard.
named approvers appear across the library
Every decision point on every procedure carries a job title, not a queue. more
steps in the library hand their unit to another function
A handoff is where a procedure stops being one team’s problem. more
controls exist in the estate, and they belong to no procedure in particular
Controls and exception classes are held estate-wide. more
Operations
What this desk is allowed to start
A surface that only reports is not operable. more
Trigger and bound
A procedure document prints purpose, scope, entry and exit, the numbered steps with the actor on each, the roles and their RACI position, the swimlane, the decision points and escalation, the handoffs, the governing rules with version and approver, the systems by rule and the timings. more
Live observability
What the record shows right now
The whole library, by lane, so a single document can be read against the estate it came from. more
Current distribution
2,748 steps
Is policy and strategy coming to fruition
Whether the written intent is holding here
Half. The document is complete and every actor on it is measured more
Not holding on the record
A procedure here carries a version, an approver, an in-force date and a last-review date. more