Protocol#

Protocol.Show

Overview#

Protocols are used to address Exception Management, sometimes referred to as NCR (Non-Conformance Report) or OCAPS (Out-of-Control Action Plan System).

The Exception Management contains essentially two objects:

• Protocol - represents the definition of the workflow.
• Protocol Instance - are run-time occurrences of the workflow based on the Protocol definition.

Each Protocol defines a workflow, as well as a set of parameters that can be used in the different Protocol states. Each Protocol state can have a specific role associated, a Checklist, parameters , dispositions for the associated materials, notes and tasks.

A Protocol Instance can be associated with one or more Materials. There are two important Protocol Instance properties which apply to all the Materials associated with the Protocol Instance:

• Inhibit Ship - the Materials cannot be shipped to another Facility while the Protocol Instance is open.
• Inhibit Move From Step - the Material Step cannot be changed while the Protocol Instance is open.

Versioned Data#

A Protocol is a change-controlled object and contains versioned data components. All versions must be associated with a Change Set to follow an approval cycle, as shown in the next picture.

graph TD
subgraph Protocol
Main1["Global Data<br>(Without Change Control)"] --- A1[None]
Main2["Versioned Data<br>(With Change Control)"] --- A2[All other]
end


classDef mermaid_title color:#000, fill:#fafafa, stroke:#fafafa, stroke-width:0x, font-size:100%, font-weight:200;
classDef mermaid_start color:#000, fill:#fafafa, stroke:#fafafa, color:#fafafa, stroke-width:0x, font-size:100%, visibility: hidden;
classDef mermaid_businessdata color:#000, fill:#65CDE8, stroke:#65CDE8, stroke-width:0px, font-size:100%;
classDef mermaid_nonbusinessdata color:#000, fill:#B7DEE8, stroke:#B7DEE8, stroke-width:0px, font-size:100%;
classDef mermaid_entity color:#000, fill:#FB9F53, stroke:#FB9F53, stroke-width:0px, font-size:100%;
classDef mermaid_entitylinked color:#000, fill:#FCD5B5, stroke:#FCD5B5, stroke-width:0px, font-size:100%;
classDef mermaid_context color:#000, fill:#B9CDE5, stroke:#B9CDE5, stroke-width:0px, font-size:100%;
classDef mermaid_optional color:#000, fill:#B7DEE8, stroke:#65CDE8, stroke-width:1px, font-size:100%, stroke-dasharray: 5 5;
classDef mermaid_state color:#000, fill:#d7e4bd, stroke:#000, stroke-width:1px, font-size:100%, font-weight:300;
class Main1,Main2 mermaid_entity
class A1,A2 mermaid_entitylinked

Tying Everything Together#

graph LR
    A1[Task] --- L1[Protocol Task]
    A2[Material] --- L2[Protocol Material]
    B1[Resource] --- B2[Protocol Resource]
    B3[Material Deviation] --- L3
    B4[Chart Data Point Occurrence] --- L3    
    B2 --- L3
    L2 --- L3[Protocol Instance]
    L3 ---|Related| L3
    A3[Employee] -.- Main[Protocol]
    A4[Chart Rule] --- Main
    A5[Data Collection Parameter] --- Main
    L3 ==== Main
    L1 --- L3
    L2 === Main
    Main --- A6[State Model]
    A6 --- A7[State Model State]
    A7 --- L4[Protocol State Detail]
    L4 -.- A8[Roles]
    L4 -.- A9[Checklist]
    Main === L5[Protocol Parameter]
    Main === L4
    L4 --- L6[Protocol State Detail Parameter]
    L5 --- L6
    L3 --- L7[Protocol Path]
    L7 --- L8[Protocol Path Parameter]
    L5 --- L8
    L7 -.- A8
    L7 -.- L9[Checklist Instance]
    L3 -.- A10[Product]
    L3 -.- A11[Facility]
    L3 -.- A12[Flow]
    L3 -.- A13[Step]

classDef mermaid_title color:#000, fill:#fafafa, stroke:#fafafa, stroke-width:0x, font-size:100%, font-weight:200;
classDef mermaid_start color:#000, fill:#fafafa, stroke:#fafafa, color:#fafafa, stroke-width:0x, font-size:100%, visibility: hidden;
classDef mermaid_businessdata color:#000, fill:#65CDE8, stroke:#65CDE8, stroke-width:0px, font-size:100%;
classDef mermaid_nonbusinessdata color:#000, fill:#B7DEE8, stroke:#B7DEE8, stroke-width:0px, font-size:100%;
classDef mermaid_entity color:#000, fill:#FB9F53, stroke:#FB9F53, stroke-width:0px, font-size:100%;
classDef mermaid_entitylinked color:#000, fill:#FCD5B5, stroke:#FCD5B5, stroke-width:0px, font-size:100%;
classDef mermaid_context color:#000, fill:#B9CDE5, stroke:#B9CDE5, stroke-width:0px, font-size:100%;
classDef mermaid_optional color:#000, fill:#B7DEE8, stroke:#65CDE8, stroke-width:1px, font-size:100%, stroke-dasharray: 5 5;
class Main mermaid_entity
class A1,A2,B1,B3,B4,A3,A4,A5,A6,A7,A8,A9,A10,A11,A12,A13 mermaid_businessdata
class L1,L2,B2,L3,L4,L5,L6,L7,L8,L9 mermaid_entitylinked
class C1,C2,C3,C4,C5,C6 mermaid_context
class N1,N2,N3,N4,N5,N6 mermaid_nonbusinessdata

click Main "../../business-data/protocol"
click A1 "../../business-data/task"
click A2 "../../business-data/material"
click A3 "../../business-data/employee"
click A4 "../../business-data/chart"
click A5 "../../business-data/parameter"
click A6 "../../administration>state_models"
click A7 "../../administration>state_models"
click A8 "../../administration/security/roles"
click A9 "../../business-data/checklist"
click A10 "../../business-data/product"
click A11 "../../business-data/facility"
click A12 "../../business-data/flow"
click A13 "../../business-data/step"
click L3 "../../business-data/protocol/protocol-instance"

Sequence Of Steps#

The necessary steps for using a Protocol are the following:

1. Create the necessary Checklists with the scope Exception Management. Note that the Checklists themselves are versioned entities.
2. Create a Protocol - note that it is necessary to associate the Protocol Version with a Change Set.
3. Approve the Change Set, which contains the Protocol Version that has been created.
4. Open as many Protocol Instances as desired.