Specification

User Requirement Specification

URS

The URS is the client's document. It states the requirement in plant terms, not control terms: throughput, product changeover time, what has to be recorded, which standards apply. It is the thing every later document is traced back to, and it is what an auditor asks for first.

Do you need this one?

Any project with a client who is not you, and every regulated project without exception. On a small in-house machine build you can fold it into the FDS, but keep the requirement numbers: traceability is the part that earns its keep.

What is in it

  1. 01Purpose and scope
  2. 02System overview and boundaries
  3. 03Operational requirements
  4. 04Functional requirements
  5. 05Data and records
  6. 06Interfaces
  7. 07Environment and utilities
  8. 08Safety and regulatory
  9. 09Non-functional requirements
  10. 10Requirement traceability
  11. 11Glossary

Written by

Client, or the integrator on the client's behalf

Approved by

Client process owner and quality

Written against

  • GAMP 5 (2nd edition)
  • IEC 62443 where the system is networked

Preview

URS.md
# User Requirement Specification
## {{PROJECT_NAME}}

| | |
|---|---|
| **Document title** | User Requirement Specification (URS) |
| **Document number** | {{DOC_NO}} |
| **Revision** | {{REV}} |
| **Date** | {{DATE}} |
| **Project** | {{PROJECT_NAME}} |
| **Client** | {{CLIENT}} |
| **Prepared by** | {{AUTHOR}}, {{COMPANY}} |

### Revision history

| Rev | Date | Description | Author | Approved |
|---|---|---|---|---|
| 0 | {{DATE}} | First issue | {{AUTHOR}} | |
| | | | | |

### Approval

| Role | Name | Signature | Date |
|---|---|---|---|
| Author | {{AUTHOR}} | | |
| Reviewer (engineering) | | | |
| Approver ({{COMPANY}}) | | | |
| Approver ({{CLIENT}}) | | | |

---

## 1. Purpose and scope

### 1.1 Purpose
This document states the requirements that {{CLIENT}} places on {{PROJECT_NAME}}. It describes
*what* the system must do. It deliberately does not describe how, which is the subject of the
Functional Design Specification.

### 1.2 Scope
**In scope**

- [Equipment, area or process covered]
- [Control system boundary]

**Out of scope**

- [Explicitly excluded items. Be generous here. Most disputes at SAT trace back to something
  that was never written down as excluded.]

### 1.3 Definitions
See section 11.

---

## 2. System overview and boundaries

[One or two paragraphs describing the process in plain language, as an operator would explain it.]

### 2.1 Battery limits

| Boundary | Description | Responsibility |
|---|---|---|
| Upstream | [e.g. infeed conveyor handshake] | [Client / Supplier] |
| Downstream | [e.g. palletiser interface] | [Client / Supplier] |
| Electrical | [e.g. 400 V supply to panel isolator] | [Client / Supplier] |
| Network | [e.g. site OT switch, port assignment] | [Client / Supplier] |

---

## 3. Operational requirements

Each requirement carries a unique reference. That reference is quoted in the FDS, in the FAT
and in the SAT, and it is how anyone proves the delivered system matches what was asked for.

| Ref | Requirement | Priority | Acceptance |
|---|---|---|---|
| URS-OP-001 | The system shall [requirement]. | Mandatory | [How this is demonstrated] |
| URS-OP-002 | The system shall [requirement]. | Mandatory | |
| URS-OP-003 | The system should [requirement]. | Desirable | |

**Priority key.** Mandatory: the system is not accepted without it. Desirable: implement if it
does not affect cost or programme. Optional: record for a later phase.

---

## 4. Functional requirements

### 4.1 Operating modes

| Ref | Requirement | Priority |
|---|---|---|
| URS-FN-001 | The system shall provide Manual, Auto and Maintenance modes. | Mandatory |
| URS-FN-002 | Mode changes shall be possible only when [condition]. | Mandatory |

### 4.2 Sequence
| Ref | Requirement | Priority |
|---|---|---|
| URS-FN-010 | On start, the system shall [sequence]. | Mandatory |
| URS-FN-011 | On stop request, the system shall [controlled stop behaviour]. | Mandatory |
| URS-FN-012 | On power restoration, the system shall [restart behaviour]. | Mandatory |

### 4.3 Alarms
| Ref | Requirement | Priority |
|---|---|---|
| URS-FN-020 | Alarms shall be prioritised and presented per ISA-18.2. | Mandatory |
| URS-FN-021 | Alarm acknowledgement shall record user and timestamp. | Mandatory |

---

## 5. Data and records

| Ref | Requirement | Retention | Priority |
|---|---|---|---|
| URS-DR-001 | The system shall record [data] at [frequency]. | [Period] | Mandatory |
| URS-DR-002 | Records shall be attributable, legible, contemporaneous, original and accurate. | | Mandatory |
| URS-DR-003 | The system shall provide an audit trail of parameter changes. | | Mandatory |

> Where records support a regulated activity, ALCOA+ applies: attributable, legible,
> contemporaneous, original, accurate, plus complete, consistent, enduring and available.

---

## 6. Interfaces

| Ref | Interface | Direction | Protocol | Data |
|---|---|---|---|---|
| URS-IF-001 | [MES / ERP / SCADA] | Bidirectional | [OPC UA / Modbus TCP] | [Payload] |
| URS-IF-002 | [Upstream machine] | In | [Hardwired handshake] | [Signals] |

---

## 7. Environment and utilities

| Item | Requirement |
|---|---|
| Ambient temperature | [range] |
| Humidity | [range] |
| Ingress protection | [IP rating, and where] |
| Electrical supply | [voltage, phases, frequency, fault level] |
| Compressed air | [pressure, quality class] |
| Area classification | [safe area / zone, and the governing standard] |

---

## 8. Safety and regulatory

| Ref | Requirement | Standard |
|---|---|---|
| URS-SF-001 | Emergency stop shall meet the required performance level. | ISO 13849-1 |
| URS-SF-002 | Machinery safety functions shall be assessed and documented. | ISO 12100 |
| URS-SF-003 | The safety related parts shall achieve PL [d/e] / SIL [1/2/3]. | ISO 13849-1 / IEC 62061 |
| URS-SF-004 | Electrical equipment of the machine shall comply. | IEC 60204-1 |

---

## 9. Non-functional requirements

| Ref | Requirement | Target |
|---|---|---|
| URS-NF-001 | Availability | [%] |
| URS-NF-002 | Scan time | [ms] |
| URS-NF-003 | Operator response time for [action] | [ms] |
| URS-NF-004 | Spare I/O capacity at handover | [%, typically 20] |
| URS-NF-005 | Spare memory and network capacity | [%] |
| URS-NF-006 | Cyber security level | IEC 62443 SL-[n] |

---

## 10. Requirement traceability

Completed as the project runs. Every mandatory requirement above must appear here with a test
that demonstrates it.

| URS ref | FDS section | Test ref (FAT/SAT) | Verified | Date |
|---|---|---|---|---|
| URS-OP-001 | | | | |
| URS-FN-001 | | | | |

---

## 11. Glossary

| Term | Meaning |
|---|---|
| FAT | Factory Acceptance Test |
| FDS | Functional Design Specification |
| SAT | Site Acceptance Test |
| URS | User Requirement Specification |

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