Microsoft PowerPoint - INCOSE 2016.pptx

COGNITION

SYSTEMS ENGINEERING

TEMPLATE KITS FOR

SMALL ENTERPRISES

JANUARY 21, 2016

COGNITION CORP

Background

• Supported large enterprises who directed our work

• Provided a tool kit allowing users to create their world

• They had procedures, process, work instructions, SOPs

• Small enterprises saw little value in a world builder tool

• Startup CEO told me “Just throw me a lifeline”

• Further discussions revealed the need for a lean approach

• We needed to have a pre built compliance world for them

• We needed to guide them through the steps to compliance

How I came to my epiphany

COGNITION CORP

Large v Small Enterprises

• All enterprises must bring their product “to compliance”

• Large enterprises have tribal knowledge

• Large enterprises have rigorous(?) processes in place

• Large enterprises have big teams, including systems engineers

• Small enterprises have minimal formal processes

• Small enterprises have limited staffs and budgets

• Small enterprises do not have “time” for early action

• Small enterprises need to move fast to survive/be purchased

Important differences in needs

COGNITION CORP

Why Template Kits

Enabling a systems engineering approach to compliance

Small enterprises do not have the sophistication to “go it alone”

• Checklists for regulatory compliance needs

• Applicable standards

• Self guided templates for product development activities

• Auto generation of compliance outputs

• Secure SaaS: lean IT, no user setup, no user maintenance

• Validated for each enterprise, not by each enterprise

• “FDA Early” approach; can support Early Feasibility Studies

• Online regulatory advisor for product development

• No special training or ramp up period; “speed to compliance”

COGNITION CORP

Checklists

• Series of questions about the system/device

• Answers trigger standards that apply

• Generates template kits

• Completing kits results in compliance outputs/artifacts

• Can be used standalone or with template kits

• Can be independent, not coupled with only one software tool

• Cognition is engaged in this work now

• Open to working with INCOSE or independent people

Guide users to applicable standards and deliverables

COGNITION CORP

EXAMPLE: DESIGN CONTROLS

• Design Controls Template kits exist to allow users to easily begin

capturing requirement, verification test, and validation test traces in

accordance with the requirements of 21 CRF 820.30.

• The Template kits alone do not ensure total compliance:

• They do not include the complete procedures that detail the design and

development process(es). These are added by users.

• They do not include custom workflow to support access rights, change

management, electronic signatures or version control. This can be

added by users.

• They can be configured/modified to suit existing procedures and

processes as required by users.

• NOTE: wherever you see “by users” implies opportunity for INCOSE or

consultants to engage with small enterprises.

COGNITION CORP

DESIGN CONTROLS TRACE MATRIX

Key deliverable is automatically generated by the template kit

COGNITION CORP

• Out of the box, the Template kit

has the structure as shown in

the screenshot.

• Inside each directory is a

document/set of documents

which have been pre-configured

to easily facilitate the capture of

requirements and tests along

with their full traceability

according to the requirements of

21 CFR 820.30.

DESIGN CONTROLS PROJECT TEMPLATE

OUT OF THE BOX

COGNITION CORP

21 CFR 820.30

Each manufacturer shall establish and maintain plans that describe or reference the design

and development activities and define responsibility for implementation. The plans shall

identify and describe the interfaces with different groups or activities that provide, or result

in, input to the design and development process. The plans shall be reviewed, updated, and

approved as design and development evolves.

REQUIREMENTS

§ 820.30(b) Design and development planning.

• Each manufacturer shall establish and maintain plans that describe or reference the

design and development activities and define responsibility for implementation.

• The plans shall identify and describe the interfaces with different groups or activities that

provide, or result in, input to the design and development process.

• The plans shall be reviewed, updated, and approved as design and development

evolves.

PART (b) - DESIGN AND DEVELOPMENT PLANNING

COGNITION CORP

• The Template kit includes a

document for the Design and

Development Plan (DDP). This

document is completed by users

early in the process.

• It is the responsibility of the

users to review, update, and

approve as design and

development evolves.

DESIGN AND DEVELOPMENT PLAN

PART (b) - DESIGN AND DEVELOPMENT PLANNING

COGNITION CORP

21 CFR 820.30

Each manufacturer shall establish and maintain procedures to ensure that the design requirements

relating to a device are appropriate and address the intended use of the device, including the needs of

the user and patient. The procedures shall include a mechanism for addressing incomplete,

ambiguous, or conflicting requirements. The design input requirements shall be documented and shall

be reviewed and approved by a designated individual(s). The approval, including the date and

signature of the individual(s) approving the requirements, shall be documented.

REQUIREMENTS

§ 820.30(c) Design input.

• Each manufacturer shall establish and maintain procedures to ensure that the design requirements

relating to a device are appropriate and address the intended use of the device, including the needs

of the user and patient.

• The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting

requirements.

• The design input requirements shall be documented and shall be reviewed and approved by

designated individual(s).

• The approval, including the date and signature of the individual(s) approving the requirements, shall

be documented.

PART (c) - DESIGN INPUT

COGNITION CORP

• The Template kit includes pre-

configured documents for

capturing and linking the User

Needs and Design Inputs.

• The sections can be renamed, re-

ordered and deleted as required.

• The User Needs are validatable

requirements and the Design

Inputs are verifiable requirements.

• It is the responsibility of the user to

review, update, and approve the

User Needs and Design Inputs.

USER NEEDS AND DESIGN INPUTS DOCUMENTS

PART (c) - DESIGN INPUT

COGNITION CORP

• The Template kit includes a pre-

configured document for capturing and

linking the lower level requirements that

drive Design Outputs.

• Engineering Requirements at any level

can link to a Design Output.

• Engineering Requirements can also link to

the Engineering Requirements at the next

level.

• Only Level 1 Engineering Requirements

can link to a Design Input.

• The Engineering Requirements can be

verifiable requirements if required.

• It is the responsibility of the user to review,

update, and approve the Engineering

Requirements.

DESIGN ACTIVITY DOCUMENT

PART (c) - DESIGN INPUT

COGNITION CORP

21 CFR 820.30

Each manufacturer shall establish and maintain procedures for defining and documenting

design output in terms that allow an adequate evaluation of conformance to design input

requirements. Design output procedures shall contain or make reference to acceptance criteria

and shall ensure that those design outputs that are essential for the proper functioning of the

device are identified. Design output shall be documented, reviewed, and approved before

release. The approval, including the date and signature of the individual(s) approving the output,

shall be documented.

REQUIREMENTS

§ 820.30(d) Design output.

• Each manufacturer shall establish and maintain procedures for defining and documenting design output

in terms that allow an adequate evaluation of conformance to design input requirements.

• Design output procedures shall contain or make reference to acceptance criteria and shall ensure that

those design outputs that are essential for the proper functioning of the device are identified.

• Design output shall be documented, reviewed, and approved before release.

• The approval, including the date and signature of the individual(s) approving the output, shall be

documented.

PART (d) – DESIGN OUTPUT

COGNITION CORP

• The Template kit includes a pre-

configured document for capturing

and linking the Design Outputs.

• The sections can be renamed, re-

ordered and deleted as required.

• The Design Outputs are verifiable

requirements.

• It is the responsibility of the user to

review, update, and approve the

Design Outputs.

DESIGN OUTPUTS DOCUMENT

PART (d) - DESIGN OUTPUT

COGNITION CORP

• The Template kit includes a pre-

configured document for displaying

a number of traces.

• The sections can be renamed, re-

ordered and deleted as required.

• New sections showing new tables

can be added as required.

• It is the responsibility of the user to

review, update, and approve the

Design Trace Matrix document.

REQUIREMENTS –TRACE MATRICES

USEFUL TOOLS

COGNITION CORP

21 CFR 820.30

Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews

of the design results are planned and conducted at appropriate stages of the device's design

development. The procedures shall ensure that participants at each design review include

representatives of all functions concerned with the design stage being reviewed and an individual(s)

who does not have direct responsibility for the design stage being reviewed, as well as any specialists

needed. The results of a design review, including identification of the design, the date, and the

individual(s) performing the review, shall be documented in the design history file (the DHF).

REQUIREMENTS

§ 820.30(e) Design review.

• Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of

the design results are planned and conducted at appropriate stages of the device's design development.

• The procedures shall ensure that participants at each design review include representatives of all

functions concerned with the design stage being reviewed and an individual(s) who does not have direct

responsibility for the design stage being reviewed, as well as any specialists needed.

• The results of a design review, including identification of the design, the date, and the individual(s)

performing the review, shall be documented in the design history file (the DHF).

PART (e) - DESIGN REVIEW

COGNITION CORP

• The Template kit includes a pre-

configured document template for

both formal and informal design

reviews.

• The Template also includes a pre-

configured log of all design

reviews.

• It is the responsibility of the user to

perform, review, update, and

approve any Design Reviews.

DESIGN REVIEWS

PART (e) - DESIGN REVIEW

COGNITION CORP

• The Information section allows basic information about the review to be

captured.

• Out of the box the Information section automatically records the project

name as well as giving fields for capturing the date and location of the

review, however, this table can be modified by users to show different

information as desired.

DESIGN REVIEW DOCUMENT TEMPLATE –INFORMATION

SECTION

PART (e) - DESIGN REVIEW

COGNITION CORP

• The Attendees section allows all review attendees to be captured. New

Attendees can be added using the ‘Add item here…’ prompt.

• Out of the box the Attendees section shows the name, job title and the role

of the attendee, however, this table can be altered by users to show

different information as required.

DESIGN REVIEW DOCUMENT TEMPLATE –ATTENDEES

SECTION

PART (e) - DESIGN REVIEW

COGNITION CORP

• The Agenda section allows all the topics to be discussed during the review

to be captured. New Agenda Topics can be added using the ‘Add item

here…’ prompt.

• Out of the box the Agenda section shows the item number and agenda

topic, however, this table can be altered by users to show different

information as required.

DESIGN REVIEW DOCUMENT TEMPLATE –AGENDA SECTION

PART (e) - DESIGN REVIEW

COGNITION CORP

• The Item(s) Under Review section shows both internal template kit

documents and external attachments which are part of the review.

• Internal template kit documents can be added using the ‘Add Internal kit

Document(s) to Review’ view (available on the Item(s) Under Review

section) using the picker.

• External attachments can be added using the ‘Add External Attachment(s)

to Review’ view (available on the Item(s) Under Review section) using the

link.

• Out of the box the Item(s) Under Review section shows the name of the

item, however, this table can be altered by users to show different

information as required.

DESIGN REVIEW DOCUMENT TEMPLATE –ITEM(S) UNDER

REVIEW SECTION

PART (e) - DESIGN REVIEW

COGNITION CORP

• The Minutes section allows the minutes for all the agenda topics to be

captured and Action Items to be created.

• Out of the box the Minutes section shows the name of the agenda item(s),

the minutes for each agenda item and any associated action items,

however, this table can be altered by users to show different information as

required.

DESIGN REVIEW DOCUMENT TEMPLATE –MINUTES SECTION

PART (e) - DESIGN REVIEW

COGNITION CORP

• The Design Review Log is a record of all the formal and informal

reviews created.

• Out of the box the table shows the review document name, the

agenda items (as identified in the review document), the last

modified date of the review document and all items that were

reviewed (as identified in the review document), however, this table

can be altered by users to show different information as required.

DESIGN REVIEW LOG

PART (e) - DESIGN REVIEW

COGNITION CORP

21 CFR 820.30

Each manufacturer shall establish and maintain procedures for verifying the device design.

Design verification shall confirm that the design output meets the design input requirements.

The results of the design verification, including identification of the design, method(s), the

date, and the individual(s) performing the verification, shall be documented in the DHF.

REQUIREMENTS

§ 820.30(f) Design verification.

• Each manufacturer shall establish and maintain procedures for verifying the device

design.

• Design verification shall confirm that the design output meets the design input

requirements.

• The results of the design verification, including identification of the design, method(s), the

date, and the individual(s) performing the verification, shall be documented in the Design

History File.

PART (f) - DESIGN VERIFICATION

COGNITION CORP

• Verification Tests can be created/linked using the ‘Add item here…’ prompt

or picker on the ‘Create/Link Verification Tests’ view (in either the Design

Inputs, Design Activity or Design Outputs documents) and are

automatically displayed in a table.

• Out of the box the table shows the requirement ID, requirement name,

acceptance criteria, attachments and the verification test ID and name,

however, this table can be altered by users to show different information as

required.

VERIFICATION TEST CREATION

PART (f) - DESIGN VERIFICATION

COGNITION CORP

• The Template kit includes pre-

configured documents to record

the verification test results for

Design Inputs, Design Activities

and Design Outputs.

• It is the responsibility of the user to

perform, review, update, and

approve all verification test results.

VERIFICATION TEST SUMMARY DOCUMENTS

PART (f) - DESIGN VERIFICATION

COGNITION CORP

• The results of Verification Tests can be recorded using the

Verification Summary documents.

• Out of the box the table shows the test ID, test name, requirement

ID, requirement name and results, however, this table can be altered

by users to show different information as required.

VERIFICATION TEST SUMMARY

PART (f) - DESIGN VERIFICATION

COGNITION CORP

21 CFR 820.30

Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall

be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents.

Design validation shall ensure that devices conform to defined user needs and intended uses and shall include

testing of production units under actual or simulated use conditions. Design validation shall include software

validation and risk analysis, where appropriate. The results of the design validation, including identification of the

design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.

REQUIREMENTS

§ 820.30(g) Design validation.

• Each manufacturer shall establish and maintain procedures for validating the device design.

• Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their

equivalents.

• Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of

production units under actual or simulated use conditions.

• Design validation shall include software validation and risk analysis, where appropriate.

• The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing

the validation, shall be documented in the Design History File.

PART (g) - DESIGN VALIDATION

COGNITION CORP

• Validation Tests can be created/linked using the ‘Add item here…’ prompt

or picker on the ‘Create/Link Validation Tests’ view (in the User Needs

document) and are automatically displayed in a table.

• Out of the box the table shows the requirement ID, requirement name,

acceptance criteria, attachments and the validation test ID and name,

however, this table can be altered by users to show different information as

required.

VALIDATION TEST CREATION

PART (f) - DESIGN VALIDATION

COGNITION CORP

• The Template includes a pre-

configured document to record the

validation test results for User

Needs.

• It is the responsibility of the user to

perform, review, update, and

approve all validation test results.

VALIDATION TEST SUMMARY DOCUMENTS

PART (f) - DESIGN VALIDATION

COGNITION CORP

• The results of Validation Tests can be recorded using the Validation

Summary document.

• Out of the box the table shows the test ID, test name, requirement ID,

requirement name and results, however, this table can be altered by users

to show different information as required.

VALIDATION TEST SUMMARY

PART (f) - DESIGN VALIDATION

COGNITION CORP

21 CFR 820.30

Each manufacturer shall establish and maintain a DHF for each type of device. The

DHF shall contain or reference the records necessary to demonstrate that the

design was developed in accordance with the approved design plan and the

requirements of this part.

REQUIREMENTS

§ 820.30(j) Design history file.

• Each manufacturer shall establish and maintain a DHF for each type of device.

• The DHF shall contain or reference the records necessary to demonstrate that the design

was developed in accordance with the approved design plan and the requirements of this

part.

PART (j) - DESIGN HISTORY FILE

COGNITION CORP

• The Template includes a pre-

configured document to index the

included content for the Design

History File.

• It is the responsibility of the user to

perform, review, update, and

approve all content of the Design

History File.

DESIGN HISTORY FILE CREATION

PART (j) - DESIGN HISTORY FILE

COGNITION CORP

DESIGN CONTROLS TRACE MATRIX

Automatically generated by the template kit; non editable

COGNITION CORP

Partnership Potential

• Cognition is pursuing this approach right now

• A better approach is a combined effort with INCOSE and others

• Cognition provides the SaaS platform but not all of the expertise

• Checklists will identify key compliance deliverables

• Templates will ensure automatic, accurate, rapid deliverables

• Which systems engineering tools should be included?

• MBSE? How appropriate for small enterprises?

• Device, drug, combination, software, hardware, etc.

• US v EU, FDA v Notified Bodies

• Goal: FDA accepts automated deliverables through online submissions

INCOSE, Industry, and Consultants/SMEs