1 design requirements & analysis. 2 pre-requisites & ground rules pre-requisites: u design...

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Design Requirements & Analysis

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Pre-requisites & Ground Rules

Pre-requisites: Design Control Training Bring draft of Requirement Documents Provide Sources of inputs to generate

Requirements Ground Rules:

Share work with other teams Team learning experience

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Topic Time (min)

Takeaways

Introduction 10

Role of Requirements 30 Why have good requirements? Benefits of having good requirements

Sources & Tools for gathering requirements

20 Sources of requirements Tools for requirements gathering

Characteristics of a Quality Requirement Statement

30 Common Characteristics of a Good Quality Requirement

Statement How to check for a good requirement Critic requirements examples

Design Control Architecture - PCD

60 Understanding the PCD - Characteristics & Examples Application through team exercise

Lunch & Breaks 60

Design Control Architecture - SRD

90 Understanding the SRD - Characteristics & Examples Application through team exercise

Design Control Architecture - SSRD

90 Understanding the SSRD - Characteristics & Examples Application through team exercise

Design Requirements & Analysis Training

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Medical Device

Design Validation

Planning

Verification & Validation

Design Verification

Customer Requirements (PCD)

System & Subsystem

Requirements

Design & Development

Design Output

DI/DO/DTM as part of PDP

Design Trace Matrix

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Design Requirements as part of PDP

Design & Development

Phase

• D&D Plan• DI Documents• RAMT• DTM

DI & Planning

Review

DevelopmentPhase

Proceed

Stopped

Revise

Planning Phase

Core TeamFormed

Team Training & Activities:•Planning•Design Input•Risk Management•Design Traceability

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Design Requirements & Analysis

Role of

Requirements

Sources & Tools of Requirements

Gathering

Characteristics of Quality Requirement Statement

Design Control Architecture:PCD, SRD & SSRD

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Why Requirements Definition is important?

Compliance Automation Inc.

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The Role of Requirements‘Who are those guys, anyways?’

A statement(s) of what user capabilities or services a system or product needs to deliver Operational need translated into

descriptions, physical and performance parameter

Objective, complete, clear, testable

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The Role of RequirementsWhy do Specifications Matter?

Are they ‘just another deliverable’? What is influenced by requirements? What role do requirements play in

development efficiency? What is the regulatory impact with respect to

requirements?

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The Role of RequirementsAdvantages of Developing Excellent Requirements

Customer - Understand customer needs, desired outcomes and product intended use

Team – On the same page, pulling in the same direction, common ownership

Planning - Defines the scope and complexity of an effort

Team members – know what is expected, sets up successful outcomes

Business – communicate, plan and deliver results

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The Role of RequirementsConsequences of Poor Requirements

Lack of a cohesive team effort Inability to launch a product Late projects, sliding schedules Cancellation at phase gate review Unsuccessful or unacceptable products

or services

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The Role of RequirementsCost Pyramid

Requirements

Architecture

Detailed Design

Manufacturing

Verification

Field Action

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The Role of RequirementsA Case Study

Incomplete requirement set on diagnostic device regarding priority of error reporting 3 stated requirements

1. Requirement for reading > 500 reported as ‘high’ result2. Error trap requirement for insufficient blood (X < 0.006)3. Error trap requirement for blood on wrong side of strip (X > 0.09)

Missing requirement• Priority of combined errors (1 and requirement 2 or 3)

Design assumption made Incomplete or inaccurate requirement analysis

Verification successful Validation does not show issue (low occurrence)

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The Role of RequirementsA Case Study (Cont)

Severe Action Taken• Field action required – recall• Agency investigations• Litigation• Probation and penalties

Potential danger to customers Lost opportunities Direct financial loss

Potential danger to customers Lost opportunities Direct financial loss

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The Role of Requirements

Understand the user need and intended use as the basis for design and development:

Without understanding the customer requirements (e.g. user needs, intended uses), what are the reasons for design and development?

Provide an accurate translation of customer need and intended use to minimize design redundancies:

Planning, design decisions and project execution can be done efficiently.

Reduces the probability that errors will be introduced through redesign or design omissions

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Create the foundation for product design and development – Product requirements are the cornerstone in providing results

Product Development Process: Cycle time reduction

Product quality fulfilling customer need and desired outcomes

Reduce or eliminate recalls and field actions

Increase NP revenues

Design (product and process) improvements: Quality product

Process and performance stability


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Complete definition and management of labeling claims:

The Marketing Team will have the competitive advantage in providing the product features to the customers.

Availability of information to suppliers for product changes.

Better control of the product development process:

The development team will be able the manage the project through prioritization.

Focus on the essential requirements of the product that will delight the customer.


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Improved quality and end-user satisfaction : Product benefits consistent with customer desires

Consistent performance

Improved, predictable reliability

Improves Team Communication: Minimizes guess work, interpretation and disconnects

Brings team to the same level of understanding

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Easier compliance with regulations through objective evident: Documented Design Verification and Validation Activities

Traceability

Reduces Rework/Redesign/Add Product Features: More efforts can be focus adding Product Features that will delight

the customers.

Improving the reliability and the quality of the products

Gain Market Share: Speed to market

Product cycle time reduction

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What’s wrong with this picture?


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Sources of Requirements

Input Sources to Marketing

Requirement Document

Business Proposal

• Regulatory Requirements

• J&J Business Requirements

• Customer input

• Technology Assessment

Marketing Requirement

Document

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• Operations

• Product Support Teams

• CAPA

Marketing Requirement

Document

PHA and Preliminary Human Factors

Analysis

Product Criteria Document

Customer - Input Sources for the PCD

Additional Input Sources: Regulatory & Statutory LifeScan Business Requirements Others

Sources of Requirements

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System Requirements

Document

Sub-system Requirements

DocumentsProduct Criteria

Document

Additional Hazards and Human Factors

Analysis

Design FMEA and Fault Tree

Analysis

Product - Input Sources for the SRD & SSRD

Sources of Requirements (cont.)Sources of Requirements (cont.)

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Product – Other Input Sources for the SRD & SSRD Marketing Competitive Benchmarking Legacy Requirements Internal Benchmarking Brainstorming Complaints Technical Services Group CAPA Other Sources

Sources of Requirements (cont.)

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Tool for Gathering Requirements

Ishikawa Fishbone (cause-and-effect) Diagram

SMBG System

ElectronicsRequirements

Labeling Requirements

Mechanical Requirements

Software Requirements

Strip & ReagentRequirements

OtherRequirements

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Advantages of cause-and-effect diagram Identify sources of requirements Apply to all levels Focus on specific issue without resorting to complaints and

irrelevancy Easy to use

Disadvantages: Relationship not well define Interrelationships not defined

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Quality Function Deployment (QFD)

Relationship

Customer to System

Cu

sto

mer

(P

CD

)

System

PriorityIm

po

rtance

System to Subsystems

Relationship

Subsystems

Imp

ortan

ce

Priority

Sys

tem

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Advantages of QFD Clear translation of customer requirements into design through logical

steps Robust and applicable to projects of varying size, scope, and

complexity Allows user to prioritize and focus on the elements that are critical to

quality (CTQ) Able to define complex inter-relationship Provides the platform for post launch design change control by

depicting trace through entire system Forces requirements to be analyzed for ambiguity and redundancy Analysis for V&V planning done with requirements definition

Disadvantages of QFD: Requires substantial up front investment Requires specialized training

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What wrong with this picture?


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Characteristics & How to Check for Goodness

Characteristics that Individual Requirement StatementShould Exhibit: Necessary Concise Implementation Free Attainable Complete Consistent Unambiguous Verifiable Correct Feasible Prioritized

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Necessary - The stated requirement is an essential capability, physical characteristic, or quality factor of the product or process. If it is removed or deleted, a deficiency will exist, which cannot be fulfilled by other capabilities of the product or process.

One good test of necessity is traceability

Traceable - You should be able to link each requirement to its source, which could be a higher-level system requirement, risk mitigation, a use case, or a voice-of-the-customer statement. Also link each requirement to the design elements, source code, and test cases that are constructed to implement and verify the requirement. Traceable requirements are uniquely labeled and are written in a structured, fine-grained way, as opposed to large, narrative paragraphs or bullet lists.

Concise (minimal, understandable) - The requirement statement includes only one requirement stating what must be done and only what must be done, stated simply and clearly. It is easy to read and understand.

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Implementation free - The requirement states what is required, not how the requirement should be met. A requirement statement should not reflect a design or implementation nor should it describe an operation.

At the system level, requirements can be truly abstract or implementation free. An example of a requirement for a monitor system at the system level is: "The system shall be capable of detecting a power failure.” This sentence should be followed by expected performance data (a quantification of what "detecting" means) against specific power failures. When no specific implementation has been stated, the system designer is free to pursue alternative, competing system designs.

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Attainable (achievable or feasible) - The stated requirement can be achieved by one or more developed system concepts at a definable cost. This implies that at least a high level conceptual design has been completed and cost tradeoff studies have been conducted.

Complete (standalone) - The stated requirement is complete and does not need further amplification. The stated requirement will provide sufficient capability.

Consistent - The stated requirement does not contradict other requirements. It is not a duplicate of another requirement. The same term is used for the same item in all requirements.

Unambiguous - Each requirement must have one and only one interpretation. Language used in the statement must not leave a doubt in the reader's mind as to the intended descriptive or numeric value.

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Verifiable - The stated requirement is not vague or general but is quantified in a manner that can be verified by one of these 4 alternative methods: inspection, analysis, demonstration or test.

Determine how the requirement will be verified.

Alarm example:

Within a system, both visual and audible alarms are often required to warn the user about abnormal or unsafe conditions. Also, the same alarm is used for multiple conditions, such as system failure, strip insertion, test results and low batteries.

To verify that both the visual and audible alarms work together, all tests must include both. Therefore, the visual and audible parts should be combined into a single requirement. Further, if the conditions providing inputs to the alarm can be incorporated into the same test or demonstration, these should also be included in the same requirement.

An example of a requirement following this approach can be "The element shall provide a visual and audible alarm under all conditions listed in Table 3-10. The alarm shall be activated no longer than 1 second after the condition exists."

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Correct - Each requirement must accurately describe the functionality to be delivered. The reference for correctness is the source of the requirement, such as an actual customer or a higher-level system requirements specification. A software requirement that conflicts with a corresponding system requirement is not correct (of course, the system specification could itself be incorrect).

Only user representatives can determine the correctness of user requirements, which is why it is essential to include them, or their close surrogates, in inspections of the requirements. Requirements inspections that do not involve users can lead to developers saying, "That doesn’t make sense. This is probably what they meant." This is also known as "guessing."

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Feasible - It must be possible to implement each requirement within the known capabilities and limitations of the system and its environment. To avoid infeasible requirements, have a developer work with the requirements analysts or marketing personnel throughout the elicitation process. This developer can provide a reality check on what can and cannot be done technically, and what can be done only at excessive cost or with other tradeoffs.

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Prioritized - Assign an implementation priority to each requirement, feature, or use case to indicate how essential it is to include it in a particular product release. Customers or their surrogates have the lion’s share of the responsibility for establishing priorities. If all the requirements are regarded as equally important, the project manager is less able to react to new requirements added during development, budget cuts, schedule overruns, or the departure of a team member. Priority is a function of the value provided to the customer, the relative cost of implementation, and the relative technical risk associated with implementation.

Three levels of priority: High priority means the requirement must be incorporated in the next

product release. Medium priority means the requirement is necessary but it can be

deferred to a later release if necessary. Low priority means it would be nice to have, but we realize it might

have to be dropped if we have insufficient time or resources.

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Characteristics of Quality Requirements

Other Characteristics of a good Requirement Unique – A requirement should have a unique label, a unique name and

unique contents. Documented and Accessible – A requirement must be documented

(e.g. writing, pictures, images, database, etc.) and the documentation must be accessible.

Identifies Applicable States – Some requirements only apply when the system is in a certain states or modes. If the requirement is only to be met sometimes, the requirement should reflect when.

For example: The vehicle shall: Be able to tow 2000-pound cargo trailer at high way speed (65 MPH) Accelerate from 0-60 MPH in less than 10 seconds

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Requirement Fundamentals

Some words to avoid for the SRD and SSRD:

Vague and general words be avoided. Avoid "flexible", "fault tolerant", "high fidelity", "adaptable", "rapid or fast", "adequate", "user friendly", "support", "maximize" and "minimize“.

For example: "The system design shall be flexible and fault tolerant".

Other words that should be avoided are "and/or", "etc." and "may".

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Here are some examples of problematic requirements:

Original: "The product shall switch between displaying and hiding nonprinting characters instantaneously."

Not feasible: Computers cannot do anything "instantaneously".

Incomplete: Does not state under what conditions the switching occurs. Does it happen automatically, or as a result of user input?

Ambiguous: What does "nonprinting characters" mean? Hidden text? Attribute tags? Control characters?

Rewritten: "The user shall be able to toggle between displaying and hiding all HTML markup tags in the document being edited with the activation of a specific triggering mechanism."

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Problematic Requirements (cont.):

Original: "The software shall be able to clear the monitor after a successful upload."

Incomplete: Under what conditions is the monitor cleared? All the time? Or is a specific action required?

Ambiguous: What does "clear the monitor" mean?

Rewritten: "After a successful upload from the monitor, the software shall query the user as to whether s/he wants to erase the uploaded test records from the monitor's database."

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Problematic Requirements (cont.):

Original: "The monitor shall be able to store up to 1500 test records."

Ambiguous: Does this mean that if the monitor can store more than 1500 records it is in violation of this requirement? Does it mean that if it can only store 1100 records that is okay ?

Rewritten: "The monitor shall be able to store at least 1500 test records."

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Before & After ExamplesOriginal: "The monitor’s push buttons may be used for optional

settings." Ambiguous: What does “may” mean?

Rewritten: "Optional settings shall be accessible through the monitor’s buttons.“

Original: "The monitor should store test results and errors. Test results include INR result, date, time, and system quality control results."

Ambiguous: Should?

More than one requirements?

Verifiable: How many test results?

Rewritten: "The Monitor shall provide storage for a minimum of 75 test results.“

“Stored test results shall include the date and time stamp, an INR result from 0.8 to 8.0 if testing passes, ‘HI INR’ for high results, ‘LO INR” for low results if a result is reported, or an error code if testing fails. Stored results also include Control 1 and Control 2 values.“

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Before & After Examples

Original: "Test strip can hold sufficient sample without overflowing." Attainable: How much is sufficient?

Rewritten: "The test strip shall accommodate a variety of sample sizes (20 to 40 micro liter) without the sample overflowing beyond the sample application area.“

Original: "The monitor retains test result memory and additional memory without batteries."

Ambiguous: What additional memory?

Rewritten: "The monitor shall store test results, calibration coefficients, algorithm coefficients, and test strip lot-specific calibration data (calibration codes) in non-volatile memory."

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Before & After Examples

Original: "At a rate of one (1) test per week, the monitor indicates a low battery condition with at least four (4) tests remaining."

Unclear: How does rate relate to indicator for low battery condition?

Rewritten: "The monitor shall indicate a low battery condition with enough remaining power for at least four tests.“

Original: "The test strip prevents direct contact between the operator and any of the test strip reagents."

Consistent Wording: Use “shall”. Operator is referred to as “user”.

Rewritten: "The test strip shall prevent direct contact between the user and any of the test strip reagents."

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Design Control Architecture

PCD Product Criteria Document

SRDSystem Requirement

Document

SRS RRSMRS ERS

Subsystem Requirement Documents (SSRD)

LRSPRS

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Design Control Architecture – PCD

Characteristics:

User/Customer NeedsA review of the Customer’s needs based upon Market Research and Focus Groups.

Intended UseA review of the claims that will be included in the labeling defining how the device will be used and who the primary end users will be. This could also include hospital guidance and interface requirements with other devices.

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Characteristics:

Regulatory and StatutoryThe domestic and international requirements for the device based upon the intended market, including any regional standards, directives, laws, and regulations.

Business NeedsSpecific Requirements mandatory for product acceptability (e.g. COGS, Quality, Reliability, etc.).

OthersDesign for ManufacturabilityTestabilityCustomer Service

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User Needs

monitor Criteria

Examples The monitor shall be easy to turn on an off.

Button functions shall be easy to understand and use.

The monitor shall automatically turn itself off after a period of inactivity to conserve battery power.

monitor display shall be easy to read and visible in normal lighting conditions.

The monitor surface shall be easy to clean and sanitize.

Test Strip Criteria

Examples The user shall be able to insert the test strip in the monitor easily.

The test strip handle area shall be clearly marked.

The sample size from a single finger stick shall be sufficient to give an accurate test.

The product shall provide accurate results over the stated life of the product if kept in its original packaging.

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Intended UsesExamples The product is intended for use by health care professionals at

the point of care.

The product is intended for use by laypersons in the home for patient self-testing.

The product shall be used for quantitative measurement of PT in fresh capillary blood as an aid in monitoring oral anticoagulation (Warfarin) therapy.

The product shall be used for quantitative measurement of PT in venous whole blood as an aid in monitoring oral anticoagulation (Warfarin) therapy.

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Regulatory and Statutory Requirements

Certification CriteriaExamples The product shall meet CAN/CSA C22.2 No. 601.1, Medical

Electrical Equipment - Part 1: General Requirements for Safety (equivalent to IEC 601.1) including any applicable collateral standards.

International Electro-technical Commission (IEC), IEC601-1-4, Safety Requirements for Programmable Electronic Medical Devices shall be followed.

Labeling and Packaging CriteriaExamples Product labeling, packaging, and documentation shall be

readable and understandable.

Product packaging and labeling shall include general instructions for how the product shall be used.

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OthersExamples The Rubicon Monitor shall be marketed in conjunction with the

Rubicon Test Strip.

The monitor shall be storable and transportable in an acceptable range of environmental conditions.

There shall be no user-serviceable components, except for batteries.

Removable parts (i.e., test strip holder and batteries) shall be field-replaceable.

Replacement parts shall be compatible with all monitors.

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Team Exercise

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Design Control Architecture – SRD

Characteristics:

FunctionalFunctional requirements specify what the design does. Focus is on the operational capabilities, the processing of inputs and the resulting outputs.

Physical & PerformancePhysical and Performance requirements specify how much or how well the design must perform, addressing such issues as speed, strength, size, weight, response times, accuracy and precision, limits of operation, etc.

InterfaceInterface requirements specify characteristics that are critical to compatibility with external systems (including user and/or patient interface, if applicable).

Others

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Functional QC Requirements

Example The monitor shall have the capability of detecting a power failure and shall not display or store result from a test that is in-progress.

System Requirements

Example The system shall produce a test temperature at the assay site of 39 +/- 1 C.⁰The system shall complete the test and display an INR result or an error message, with time and date stamp, within 2 minutes of sample application

Monitor Requirements

Example Batteries inserted incorrectly (wrong polarity) shall not damage the monitor.

The Monitor shall turn itself off to conserve battery power after at least 90 seconds of being idle while waiting for user action.

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Physical and Performance Requirements monitor Requirements

Example The monitor dimensions shall be no greater than 8.0” long x 3.4” wide x 2.2” high (20.3 cm long x 8.6 cm wide x 5.6 cm high).

Test Strip Requirements

Example The test strip dimensions shall allow easy insertion of the test strip to be into the test strip holder.

System Requirements

Example The system shall provide accurate results for a temperature range of 15 to 35° C.

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Interface Requirements Monitor Requirements

Examples The monitor shall prompt the user to confirm or reset the CalCode.The monitor shall alert the user if the test strip is inserted incorrectly.

Test Strip RequirementsExamples The test strip shall be clearly marked as to the orientation and

direction of insertion. The test strip shall prevent direct contact between the user and any of the test strip reagents.

Labeling RequirementsExamples Product labeling shall conform to 21CFR820 part 809.10.

Product labeling shall conform to CAN/CSA C22.2 No 601.1. Product labeling shall contain instructions for the user to properly and safely operate the system.

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Team Exercise

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Design Control Architecture – SSRD

Functional Physical & Performance Interface General Design Goals & Constraints

SRS RRSMRS ERS

Subsystem Requirement Documents (SSRD)

LRSPRS

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Characteristics:

FunctionalFunctional requirements specify what the design does. Focus is on the operational capabilities, the processing of inputs and the resulting outputs.

Physical & PerformancePhysical and Performance requirements specify how much or how well the design must perform, addressing such issues as speed, strength, size, weight, response times, accuracy and precision, limits of operation, etc.

InterfaceInterface requirements specify characteristics that are critical to compatibility with external systems (including other Subsystem and user and/or patient interface, if applicable).

General Design Goals & Constraints

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Software Design Constraints

General Design Constraints Regulatory Policies Hardware Limitations (e.g. time requirements) Interfaces to Other Applications Parallel Operation Audit Functions Control Functions Higher-Order Language Requirements Handshake Protocols Critical Nature of Application Safety and Security Considerations

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Software Design Constraints

General Design Constraints Hardware Software Serial Communication

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Software

Functional RequirementsThe essential functions provided by the software product. These requirements detail the behavior of the software. They should be grouped according to the product functions specified in the Product Function Overview. Sections may include; General Functions, Power-On and Self-Test, Serial Command Processing, Configuration of monitor Options, Performing a Glucose Test, and Reviewing Stored Data. Each section should contain those requirements associated with that particular function.

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Software

Functional Requirements General Functions Power-On and Self Test Serial Communications Serial Command Processing monitor Configuration Data Storage Test Mode Calibration Strip Mode Setup Mode Data Review Mode User Data Management Mode Mimic Mode Functional Tests

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Software

User Interface RequirementsDescribe aspects of the part of the software that interfaces the user to the monitor or application. This might include response time for button presses, debouncing requirements, minimum font size restrictions, standard error message formats, standard objects that must appear on every screen, etc. Do not include screen images or other design information in this section unless they truly represent a required feature.

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Software

External Interface RequirementsExternal interfaces can include interfaces to hardware components of the system (displays, buttons, sensors, valves, etc), software components of the system (databases, drivers, etc.), or external devices (via serial port or network connection).

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Software

Performance Interface RequirementsDescribe the numerical requirements placed on the software or user interaction with the software. Only measurable performance parameter shall be specified (file size, response time, frequency, etc.). Performance requirements for a particular function should be specified in the appropriate “Functional Requirement” section.

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Electronics

General Design Goals and Constraints Electronic Components Size Weight Yield Cost Testability

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Electronics

Interface Requirements Mechanical Strip & Reagent Software

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Electronics

Functional Requirements monitor Measurement Requirements CALCODE Setting and Input Power Supply Generation & Distribution System Architecture

• Test Result and Calibration Memory (e.g RAM)• Processors• ASIC

Buttons Audio Communication Interface Battery Requirements

• Life• Installation

Real Time Clock System Fault Requirements

• Detection• Reporting

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Electronics

Functional Requirements Sample Application Detection Strip-In-Place Detection Assay Detection Reagent Temperature Control

• Heater Driver

• Heater Sensor Amplifier

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Electronics

Physical and Performance Requirements Electromagnetic Compatibility

• Electrostatic Discharge

• Electromagnetic Immunity

• Electromagnetic Emissions Accuracy & Precision

• Drift Voltage

• Reference voltage

• Frequency

• System Timing Accuracy

• Resolution of ADC

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Electronics

Durability & Reliability Requirements MTTF & MTBF Operating Environmental Conditions

• Temperature

• Humidity

• Altitude Non-Operating Environmental Conditions

• Storage

• Shock

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Mechanical

General Design Goals and Constraints Mechanical Components Size Weight Yield Cost Testability

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Mechanical

Interface Requirements Electrical Strip & Reagent

• Test Strip Insertion• Test Strip Support• Strip Holder

Software

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Mechanical

Functional Requirements System Fault Requirements

• Detection• Reporting

Sample Application Sensor• Sample Detection

Assay Optics• Optical System

Strip in Place Detection• Test Strip Detection

Reagent Temperature Control• Test Strip Temperature• Blood Sample Temperature

Battery Requirements• Battery Type• Battery Life• Installation

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Mechanical

Functional Requirements (cont.) Monitor Assembly

• Temperatures• Alternative Power Source• Cleaning• Display• Graphics• Ergonomic• Safety• Identifier

Buttons• Requirements• Interface

Communication Interface• Data/Serial Communications Port• Power Port• Data Port Recognition

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Mechanical

Physical and Performance Requirements Sample Application Sensor

• Wavelength• Window Transmission Percentage

Heater• Temperature• Sensor

Monitor• Label Area• Shipping• Storage• Shock Hazard• Fire Hazard• Size• Weight

Electromagnetic Compatibility• ESD Emissions

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Mechanical

Durability & Reliability Requirements MTTF & MTBF Operating Environmental Conditions

• Temperature• Humidity• Altitude• Light• Orientation

Non-Operating Environmental Conditions• Storage• Shock• Rigidity• Impact• Vibration• Fluid Intrusion• Cleaning & Chemical Resistance

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Strip & Reagent

General Design Goals and Constraints Size Yield Cost Testability

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Strip & Reagent

Functional Requirements QC Requirements CalCode Requirements PT Reagent

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Physical and Performance Requirements Test Strip and Strip-in-Place Dimensions Cleanliness Thermal Characteristics Fluidic Characteristics (e.g Flow Channel) Physical Attributes (e.g. Clarity) Precision & Accuracy Stability Shipping

Strip & Reagent

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Interface Requirements Mechanical Characteristics Electrical Characteristics Software Strip Handling

Strip & Reagent

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Labeling

Labeling on the monitor User Needs

Example: All monitor labeling shall be clearly legible. Regulatory/Statutory

Example: The monitor label shall specify “For In Vitro Diagnostic Use”.

LifeScan Labeling RequirementsExample: The monitor label shall include a LifeScan copyright

symbol.

Owner’s Booklet User Needs

Example: The Owner’s Booklet shall contain instructions for the user to properly and safely operate all components of the system.

Regulatory/StatutoryExample: The Owner’s Booklet shall include all applicable

equipment classifications from CAN/CSA 601.1-M90 Clause 5. LifeScan Labeling Requirements

Example: The Owner’s Booklet shall include an artwork number.

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Labeling

Logbook User Needs

Example: The logbook shall provide space to record the result of each test.

LifeScan Labeling RequirementsExample: The Owner’s Booklet Addendum shall include an

artwork number. monitor Kit Carton Labeling

User NeedsExample: The monitor carton label shall contain the LifeScan

Customer Support and Service number. Regulatory/Statutory

Example: The monitor carton label shall include all information appearing on the monitor label.

LifeScan Labeling RequirementsExample: The monitor carton label shall contain LifeScan

copyright notice. Labeling on the Test Strips

User NeedsExample: The test strips shall have graphics printed on the top

side to aid the user in inserting the strip with the right side up.

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Labeling

POC and PST Test Strip Bottle Labels User Needs

Example: The POC and PST test strip bottle labels shall contain instructions for proper storage.

Regulatory/StatutoryExample: The PST test strip bottle label shall contain the

“Rx Only” designation. LifeScan Labeling Requirements

Example: The POC and PST test strip bottle labels shall contain relevant patent numbers.

POC and PST Test Strip Carton Labeling User Needs

Example: The POC and PST test strip carton labeling shall have the expiration date prominently displayed.

Regulatory/StatutoryExample: The POC and PST test strip carton labeling

shall include a Lot Number. LifeScan Labeling Requirements

Example: The POC and PST test strip carton labeling shall contain a product number and barcode.

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Labeling

POC and PST Test Strip Package Inserts Intended Use

Example: The POC and PST test strip package insert shall state that the product is for use with the monitor.

User NeedsExample: The POC and PST test strip package inserts shall provide a quick reference

to the steps for performing a test using the monitor INR Monitoring System. Regulatory/Statutory

Example: The POC and PST test strip package inserts shall describe physical, biological, or chemical indications of instability or deterioration of the reagent.

LifeScan Labeling RequirementsExample: The POC and PST test strip package inserts shall include an artwork number.

monitor Kit Shipping Labeling User Needs

Example: The monitor shipper labeling shall specify the temperature and humidity ranges for transport and storage of the monitor.

LifeScan Labeling RequirementsExample: The monitor shipper labeling shall contain a product number and barcode.

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Labeling

POC and PST Test Shipper Labeling User Needs

Example: The test strip shipper labeling shall indicate the number of cartons contained in the shipper.

LifeScan Labeling Requirements

Example: The test strip shipper labeling shall contain a part number and barcode.

Instructor’s Guide Intended Use

Example: An Instructor’s Guide shall be created for use in training and certification of PST users.

User Needs

Example: The Instructor’s Guide shall provide written and hands-on exercises to be performed by the trainees.

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Team Exercise