RAPAT® for Excel 365
Requirements Help Sheet

Overview

Before a device or equipment is designed or manufactured, it is essential to understand the user requirements. Lessons from the past indicate that a great deal of effort and resourcing can be wasted if this is not done. The identified requirements provide the essential criteria against which design, manufacture, and testing activities can be assessed and appropriate development decisions made.

Overview of Technology

Note basic details of the technology, its intended use and the associated company.

Regulations, Codes, and Standards

Provide reference to any regulations, codes, or standards which have been identified to be used to inform requirements identification. Codes could be related to design, manufacture, testing, quality, transportation, operation, safety, environment, etc.

Certification Requirements

Record details of certification requirements for the technology.

General Functions and Functional Requirements

The general functions need to identify everything that the device has to do at every stage of its use. This might include what the device has to do to be able to be transported (e.g. pack away), to be installed (to be installable in various scenarios), to be able to provide stand-by / idle functions (to remain charged and ready for use), to be able to provide any number of active functions (open when needed, close when not needed, contain fluid, enable flow, etc), to be able to provide safety functions (to protect user from harm), to be able to be cleaned / maintained / disposed of (e.g. able to be dismantled and re-assembled, etc.).

The functional requirements then need to identify how each of the general functions need to be delivered (e.g. duration of stand-by power, min / max flowrates, exposure durations, chemicals to be compatible with, etc.). Where these functions and functional requirements are driven by codes, standards, and regulations, these need to be referenced.

Separate tables are provided to additionally capture requirements related to interfaces, and requirements related to software, in addition to the main equipment functional requirements. For technology that is primarily software, this third table will be dominant.

User Identification and User Specific Requirements

The user specific requirements will normally be in addition to the general functional requirements. They will relate to the usability, comfort, and convenience of the device for the range of users who will interact with it. Some of these requirements will be essential, while some may be "softer" and less essential, although these may still represent the difference between success and failure. Different users whose requirements may need to be addressed could include, for example, the transporter, installer, operator, receiver, maintainer, etc. Role-specific requirements should be identified here. Each user type should be defined only once, but multiple requirements may be affiliated with each user.

The types of users defined in the 'User Identification' table will be used to populate the 'Type of User' column in the following 'User Specific Requirements' table.

Procedures, Instructions, and Training Requirements

Procedures

• Safe installation, operation and maintenance may depend on specific procedures being followed. Any requirements for such procedures should be captured here.

Signage / Labelling / Instructions

• Regulations and standards may stipulate specific labelling and instructions requirements to ensure safe installation, operation and maintenance of the device. These do not relate to the device functionality and so might be missed if not captured in this section. User specific labelling and instruction requirements may also be captured here.

User Training

• There may be a need to define and provide user training to ensure the device is safely and correctly used. Requirements for training should be captured here.

Lifecycle Requirements

At different stages of the product lifecycle there will be requirements on how the product is interacted with. These are not requirements on the device functionality, but on what is done to the device, such as requirements on how the device is manufactured, how it is handled, how it is maintained, and how it is disposed of.

Manufacturing Requirements

• These relate to how the device is manufactured and may include: manufacturing tolerances / tolerance stack-up, cleanliness and/or sterility of the manufacturing process and/or of the final product, limitations or controls on handling during manufacture to minimise damage or contamination and any H&S considerations that need to be managed as a result of manufacture / assembly, such as potential exposure to heat, electricity, lasers, chemicals, etc.

Handling Requirements

• These relate to how the device should be handled once manufacturing and assembly are complete. Handling requirements may include: how the device should be lifted, how it should be packaged for safe transportation, how it should be transported to minimise risk of damage, and how it should be stored (e.g. avoiding UV light, extreme temperatures, humidity, dust, etc.).

Maintenance Requirements

• These relate to how the device should be maintained once in use. Maintenance requirements may include: identifying different types of maintenance (e.g. cleaning, lubrication, replacement of parts, etc.), any specific tools required to undertake each type of maintenance (e.g. to minimise damage), the frequency each type of maintenance should be undertaken to protect the safety and durability of the device (e.g. daily, weekly, monthly, annually, etc.). It may also be beneficial to identify the likely duration of the maintenance, so that it can be scheduled with minimum disruption and/or minimum risk to the technician.

End of Life Requirements

• End of life requirements relate to how the product will be managed when it reaches the end of its service life. This may include dismantling or cleaning to make safe. It may also include identifying components for re-use, components which have been designed or selected to be recyclable, and those which need to be disposed of. The requirements may also include any instructions for safe disposal.

Types, characteristics, and examples of requirements

There are many different types of requirements which will often need to be met for a new product to be acceptable to users. For example, requirements related to certification, labelling of products, required functions, expected performance, product life, as well as specific user requirements. The main aspects to consider include:

• What does the device have to do, and how well does it have to do it (function / performance requirements)?
• What is the expected operational life based on normal usage and maintenance? Are there any warranty requirements?
• How long must the device work before it needs maintenance or failure is acceptable?
• Can the device be re-used? Are there any specific disposal concerns at end of life?
• Are there any health and safety risks from the use, or failure, of the device?
• Are there any health and safety risks during manufacture, testing, storage, and delivery?
• What environments might the device see during operation? What is normal and what is extreme?
• How carefully should the device be stored and delivered? What loads, temperatures, and environments could it see?
• Does the design or manufacturing process need to conform to an existing code, standard, or regulation?
• What inspection, testing, monitoring, and maintenance is required? Does a third party need to be involved?
• Who is able to provide certificates of compliance with specific codes, standards, and regulations, if required?

How to find out what the requirements are

It is important to start by identifying the potential users of the device / equipment. Early discussions with users can be very beneficial to understanding their needs. In addition, online searches for competing / comparable technologies may indicate required testing, codes and certification. Standards organisations such as BSI and ISO also have searchable databases to help find relevant codes, standards, and regulations. However, reading through and understanding these documents can be time consuming. Therefore, it is recommended that a discussion and/or small workshop is held with technical experts, users and champions with detailed knowledge of the application and relevant regulation.

Once the key requirements for the device have been identified, these may need to be further considered in the context of specific components and parts e.g. materials or component specifications. For devices which interface with other equipment, there may also be a need to understand and align with the wider system requirements.

It is essential to understand the requirements early in the development of the device to ensure that it can achieve user acceptance. However, as the product is developed, more detailed specifications may evolve from these initial requirements so that detailed design and manufacturing specifications can be developed as well as testing procedures, maintenance and training guides, etc.

Well-written requirements

It is important that requirements:

• Are traceable, to identify where they have come from and to be able to reference in the future
• Use concise language that is easy to understand
• Focus on what is essential and necessary; use words such as "must" and "shall"
• Are measurable and objective, not vague or open to interpretation

Using the Worksheet

Sheet-wide features

• The 'Requirements Assessment Completion Status' indicates progress towards sheet completion. The value provided from the dropdown will update the 'Navigation' page accordingly.
• Add Row(s): Rows can be added to the following tables:
  • All Regulations, Codes, and Standards tables
  • All General Functions and Functional Requirements tables
  • User Identification
  • User Specific Requirements
  • Procedures, Instructions, and Training Requirements
  • All Lifecycle Requirements tables
  This functionality can be accessed by right-clicking a cell in any of these tables and selecting 'Add Row(s)' from the 'RAPAT' option in the context menu. If the currently selected cell is in the final row of a table, a dialog box will appear where the number of new rows to be added to the bottom of the table can be defined. If the currently selected cell is elsewhere in the table, a single row will automatically be inserted beneath the current cell. Reference numbers, formatting, and functionality will be automatically applied.
• Delete Rows(s): Rows can be deleted from the following tables, to a minimum of one remaining row:
  • All Regulations, Codes, and Standards tables
  • All General Functions and Functional Requirements tables
  • User Identification
  • User Specific Requirements
  • Procedures, Instructions, and Training Requirements
  • All Lifecycle Requirements tables
  This functionality can be accessed by right-clicking a cell in any of these tables and selecting 'Delete Row(s)' from the 'RAPAT' option in the content menu. If this action is applied while multiple rows are selected, all of the selected rows will be deleted.

Table features

• User Identification / User Specific Requirements table
  • Different user types can be defined in the 'User Identification' table. Values in the 'Type of User' column will populate the dropdown in the 'User Specific Requirements', allowing requirements to easily be associated with defined users. If necessary, users in the 'User Identification' table can be updated, with any changes being automatically reflected in the 'User Specific Requirements' table.
• Lifecycle Requirements
  • Requirement Types can be defined in the first column of the table. These values populate the dropdown in the 'Requirement Category' column. The Requirement Types can be updated, with any changes being automatically reflected in the 'Requirement Category' column.