No Current Link To VocabularyCoded With ExtensionsCoded No Extensions
POCP_HD030200UV01
E_ProductEstablishment

(Link to Excel View)
Derived from RMIM: POCP_RM030200UV01
 
Organization

Design Comments: The organization that assigned the identifier. A choice between the general product organization CMET and a previously used alternatively named class, which is preserved for backwards-compatibility only.

classCode [1..1] (M)
Organization (CS) {CNE:V:EntityClassOrganization, root= "ORG"}

Design Comments: Fixed to ORG (organization).

determinerCode [1..1] (M)
Organization (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"}

Design Comments: Fixed to INSTANCE for this is a particular organization instance, not a general description of an organization.

id [0..*]
Organization (DSET<II>)

Design Comments: A unique identifier for the organization.

name [0..1]
Organization (ON)

Design Comments: A text name for the organization.

telecom [0..*]
Organization (DSET<TEL>)

Design Comments: One or more telecommunication addresses for the organization. This includes phone numbers, fax numbers, and email addresses.

addr [0..1]
Organization (AD)

Design Comments: A postal address for the organization.

assignedEntity1 [0..*] (AssignedEntity3)

Design Comments: Connects an organization with a superordinate organization, such as a manufacturer to a registrant or labeler. This is the inverse of the AssignedEntity role which links the Organization to sub-organizations. If a business operation (performance/actDefinition) is to be connected to a manufacturer Organization, then this presently defined "upward" pointing AssignedEntity role must be used, not the other one.

contactParty [0..*] (ContactParty)

Design Comments: Links a person to an Organization as a contact party for that Organization.

assignedEntity2 [0..*] (AssignedEntity)

Design Comments: Links an establishment to the main organization. Such establishment may be a manufacturing facility, subsidiary, contractor, or other business partner. Notice this AssignedEntity role is configured such that hierarchies of related organizations can be expressed.

Design Comments: #nosuffix

otherLocation [0..*] (OtherLocation)

Design Comments: Links a person to an Organization as a contact party for that Organization.

 
AssignedEntity3

Design Comments: Connects an organization with a superordinate organization, such as a manufacturer to a registrant or labeler. This is the inverse of the AssignedEntity role which links the Organization to sub-organizations. If a business operation (performance/actDefinition) is to be connected to a manufacturer Organization, then this presently defined "upward" pointing AssignedEntity role must be used, not the other one.

classCode [1..1] (M)
Role (CS) {CNE:V:RoleClassAssignedEntity, root= "ASSIGNED"}

Design Comments: Fixed to ASSIGNED, indicating the playing organization is assigned by the scoping organization to act in specified capacities on their behalf. The capacities are specified by the performance participation linking to the act definitions.

code [0..1]
Role (CD) {CWE:D:ProductLifecycleAssignedRoleType}

Design Comments: An indication of the role played by the organization for the scoping organization.

confidentialityCode [0..1]
Role (CD) {CWE:D:Confidentiality}

Design Comments: An indication of the level of confidentiality to be accorded to the scoping organization.

representedOrganization [1..1] (Organization)
subjectOf [0..*] (Subject2)
performance [0..*] (PrimaryPerformer)
 
ContactParty

Design Comments: Links a person to an Organization as a contact party for that Organization.

classCode [1..1] (M)
Role (CS) {CNE:V:RoleClassContact, root= "CON"}

Design Comments: Fixed to CON (contact).

code [0..1]
Role (CD) {CWE:V:ContactRoleType}

Design Comments: A code specifying the purpose of the contact. Example: administrative contact, technical contact, incident reporting contact, etc.

name [0..1]
Role (PN)
addr [0..1]
Role (AD)

Design Comments: A postal address for reaching the person in this role of contact for the scoping Organization.

telecom [0..*]
Role (DSET<TEL>)

Design Comments: A telecommunications address, e.g., phone number, email address, for reaching the person in this role of contact for the scoping Organization.

confidentialityCode [0..1]
Role (CD) {CWE:D:Confidentiality}

Design Comments: Specify 'B' to remove the contact information from published data.

contactPerson [1..1] (Person)

Design Comments: An individual person being engaged in any way with the product life cycle. The manner by which such person is engaged is evident from the role and participation in acts. Notably, persons may be contact persons for organizations or assigned persons that execute activities on behalf of organizations.

 
Person

Design Comments: An individual person being engaged in any way with the product life cycle. The manner by which such person is engaged is evident from the role and participation in acts. Notably, persons may be contact persons for organizations or assigned persons that execute activities on behalf of organizations.

classCode [1..1] (M)
Person (CS) {CNE:V:EntityClassPerson, root= "PSN"}

Design Comments: Fixed to PSN (person in the sense of natural person, human being.)

determinerCode [1..1] (M)
Person (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"}

Design Comments: Fixed to INSTANCE for this is a particular individual, not a general description of a kind of person.

name [0..1]
Person (PN)

Design Comments: The person's name.

 
AssignedEntity

Design Comments: Links an establishment to the main organization. Such establishment may be a manufacturing facility, subsidiary, contractor, or other business partner. Notice this AssignedEntity role is configured such that hierarchies of related organizations can be expressed.

Design Comments: #nosuffix

classCode [1..1] (M)
Role (CS) {CNE:V:RoleClassAssignedEntity, root= "ASSIGNED"}

Design Comments: Fixed to ASSIGNED, indicating the playing organization is assigned by the scoping organization to act in specified capacities on their behalf. The capacities are specified by the performance participation linking to the act definitions.

code [0..1]
Role (CD) {CWE:D:ProductLifecycleAssignedRoleType}

Design Comments: A code value that describes the role played by the assigned organization.

confidentialityCode [0..1]
Role (CD) {CWE:D:Confidentiality}

Design Comments: An indication of the level of confidentiality to be accorded to the activity of the performing organization.

assignedOrganization [1..1] (Organization)
subjectOf [0..*] (Subject2)

Design Comments: Provides the ability to specify exact geographical location of the site.

performance [0..*] (PrimaryPerformer)

Design Comments: Links an establishment to the activity that it is assigned to perform in this business relationship.

 
Subject2

Design Comments: Provides the ability to specify exact geographical location of the site.

typeCode [1..1] (M)
Participation (CS) {CNE:V:ParticipationTargetSubject, root= "SBJ"}
position [1..1] (A_SpatialCoordinateUniversal)
 
PrimaryPerformer

Design Comments: Links an establishment to the activity that it is assigned to perform in this business relationship.

typeCode [1..1] (M)
Participation (CS) {CNE:V:ParticipationPrimaryPerformer, root= "PPRF"}

Design Comments: Fixed to PPRF (primary performer).

actDefinition [1..1] (ActDefinition)

Design Comments: Specifies the kind of activity assigned to an establishment.

 
ActDefinition

Design Comments: Specifies the kind of activity assigned to an establishment.

classCode [1..1] (M)
Act (CS) {CNE:V:ActClassRoot, root= "ACT"}
moodCode [1..1] (M)
Act (CS) {CNE:V:ActMoodDefinition, root= "DEF"}
code [0..1]
Act (CD) {CWE:D:ManufacturerActivityActType}

Design Comments: A code that provides information about the type of manufacturer activity that the performing entity is capable of carrying out.

text [0..1]
Act (ED)

Design Comments: A text description of the type of manufacturer activity that the performing entity is capable of carrying out.

effectiveTime [0..1]
Act (IVL<TS>)

Design Comments: A specification of the time period during which the performing entity is capable of carrying out the act in question.

product [0..*] (Product)

Design Comments: A relationship linking the activity with a specific product, allows distinguishing, for example, that a manufacturer is the manufacturer of the 500 mg capsule rather than the injectable solution form of a drug.

 
Product

Design Comments: A relationship linking the activity with a specific product, allows distinguishing, for example, that a manufacturer is the manufacturer of the 500 mg capsule rather than the injectable solution form of a drug.

typeCode [1..1] (M)
Participation (CS) {CNE:V:ParticipationProduct, root= "PRD"}

Design Comments: Fixed to PRD (product). "Product" in this context (as a participation of an act) means that which is "brought forth" by the activity (literal meaning of latin "producere"), not that it is necessarily made from scratch in the supply act. So it includes products that come out of an inspection step.

manufacturedProduct [1..1] (ManufacturedProduct3)

Design Comments: A pass-through Role whose player is the kind of product produced by the establishment. The MaterialKind code can refer directly to the Product code, and does not need to refer to a higher-order product class.

 
ManufacturedProduct3

Design Comments: A pass-through Role whose player is the kind of product produced by the establishment. The MaterialKind code can refer directly to the Product code, and does not need to refer to a higher-order product class.

classCode [1..1] (M)
Role (CS) {CNE:V:RoleClassManufacturedProduct, root= "MANU"}
id [0..1]
Role (II)

Design Comments: This id can be used for internal refernece purposes to avoid replicating unidentified roles just for the purpose of referencing the playing entity. For instance, the ManufacturedProduct role also has an id, and if both ids are the same, the product reference is made without even specifying the MaterialKind entity.

manufacturedMaterialKind [0..1] (E_ProductMaterialKindUniversal)
 
OtherLocation

Design Comments: Links a person to an Organization as a contact party for that Organization.

classCode [1..1] (M)
Role (CS) {CNE:V:RoleClassServiceDeliveryLocation, root= "SDLOC"}

Design Comments: Fixed to SDLOC (service delivery location)

code [0..1]
Role (CD) {CWE:D:HealthcareServiceLocation}

Design Comments: A code indicating the role this other location plays in the scope of the Organization.

addr [0..1]
Role (AD)

Design Comments: The address for finding the location.

telecom [0..*]
Role (DSET<TEL>)

Design Comments: A telecommunications address, especially phone number, at that location.