Pen Design Plan

This article demonstrates a plan to design the pen described in another article on Design Controls, and may not make sense if you haven’t read “Design a pen.”

In that article I began with a quote from Leonardo DeCaprio from the movie Wolf of Wall Street where he challenged his team to “sell me this pen,” implying a good salesman could sell anything. I believe a good team could design anything so I demonstrated how to use Design Control requirements to create innovative, safe products especially in healthcare. There’s a balance between too many restrictions and not enough freedoms that comes from practice; that article gave advice, this one demonstrates a project-plan and may not make sense without having read the first.

I use this plan as a starting point for more complex products in hands-on workshops and it may not be as useful to a reader without that context.

Scope

This article is an initial draft a design plan to demonstrate concepts explained in the article Design me a pen. From this point on it will be referred to as a plan but it’s a discussion point rather than a complete project plan. A useful plan would have enough detail and references so that anyone not familiar with your processes could complete the plan without asking questions or needing more information; they would know why they are working, what they need to do, and how to do it including with whom to communicate.

This plan documents design inputs, the minimum required design reviews, and preliminary examples of tests that will be required for verification and validation. It shall be continuously updated using design change procedures in accordance with company quality control policies.

This plan is only for design controls, from design inputs to design transfer. It does not cover other aspects of development such as process controls, post-market surveillance, risk, or master validation planning.

References

FDA 21 CFR 820.30ISO 13485

PenUserNeeds.doc (fictional document)PenRegulatoryRequirements.doc (fictional document)ISO-standard-Example-1 (fictional ISO standard)ASTM-standard-Example-1 (fictional ASTM standard)

Definitions

See our corporate Design Control policy for definitions of the following terms used throughout this plan:

Design & Development Planning 21CFR820.30 (b)Design Input 21CFR820.30 (c)Design Output 21CFR820.30 (d)Design Review 21CFR820.30 (e)Design Verification 21CFR820.30 (f)Design Validation 21CFR820.30 (g)Design Transfer 21CFR820.30 (h)Design Changes 21CFR820.30 (i)Design History File 21CFR820.30 (j)

Deliverables & Design History File

The following documents must be completed prior to design transfer. Any changes to this plan shall be documented with the rational for changes and relevant test data as the Design History File. All changes or updates to this plan will be considered project reviews, but sub-teams may have additional reviews when creating design outputs or tests.

Design Planning, Design Reviews, & Design History File

ThisPlan.doc

ThisPlan-Completed.doc (the final report, ensuring all deliverables)

Design Inputs

PenDesignInput.doc

Design Verification, Validation, & Transfer

PenVerificationTestProtocol-1.doc

PenVerificationTestProtocol-1-Results.doc

PenVerificationTestProtocol-2.doc

PenVerTestificaitonProtocol-2-Results.doc

PenVerificationTestProtocol-3.doc

PenVerification TestProtocol-3-Results.doc

PenValidationTestProtocol-1.doc

PenValidationTestProtocol-1-Results.doc

PenValidationTestProtocol-2.doc

PenValidationTestProtocol-2-Results.doc

PenValidationMasterPlan.doc

Pen TraceMatrix.doc

Design Outputs

Pen system-level drawing.dwg

Pen mechanical drawings.dwg1, .dwg2, .dwg3

Ink chemical specifications.spc

Packaging drawings.dwg

Labeling drawings.dwg

Design Inputs

Design inputs are comprised of user needs, risk management, regulatory requirements, and business needs. Design inputs must be verified or validated prior to design transfer using documented protocols with pre-determined acceptance criteria, must be completed before transfer to manufacturing, and must be updated every three months throughout this project including the six months after design transfer and use in the field. Risk Management must be updated on the same schedule and include members of manufacturing and post-market surveillance in the updates.

Company risk management policies shall take priority over other design inputs or requirements.

For simplicity, this plan is consolidates all input documents into this page in an abbreviated format.

User Needs (design document available to all departments):

#UN1 visible on a range of patients’ skin colors#UN2 sterile pen#UN3 sterile and non-toxic ink#UN4 easy to hold and use

Risk Management (shared document used by design, manufacturing, purchasing, distribution, and field service departments):

#RM1 must not risk an unsterile product reaching a patient#RM2 must risk patient safety by slipping in a user’s hand during surgery

Regulatory Requirements (design document available to all departments):

#RN1 Must use ink or marking material that’s approved by regulatory agencies in the United States and European Union

Business Requirements (design document available to all departments):

#BN1 Must be color-coded to match corporate brand: “blanched almond,” hex code “ffebcd.”

Design Requirements

Design requirements are for the benefit of design teams and must be linked to Design Inputs. Suggestions for how to verify or validate are non-binding, not exhaustive, and must be described in detail in other documents. For simplicity, this plan is consolidates all requirements documents into this page in an abbreviated format.

System-level requirements:

#SR1 ink must not leak when pen shaken by a typical user*#SR2 ink and pen able to be sterilized using gamma radiation#SR3 able to be used 10 times without failing**

Mechanical requirements:

#MR1 must not slip out of hands in a typical hospital surgery room environment*

Ink requirements, version 2:

#IR1 color = silver, hex code “??????”#IR2 color able to be seen on typical patients’ skin, including diverse races, in typical operating room lighting

Packaging requirements:

#PR1 must hold 6 pens

Labeling requirements:

#LR1 must adhere to EU MDR requirements

Verification & Validation

System-level:

#SR1 and #SR3 shall be verified using the test protocol VerTestProtocol-1.doc and documented in VerTestProtocol-1-Results.doc#SR2 shall be verified using methods described in ISO-standard-Example-1.

Mechanical:

Ink:

Packaging:

Labeling:

#LR1 shall be verified using Design Output documents on size, shape, and material selection; and by manufacturing inspection protocols Man-Protocol-ex1.doc.

Transfer to Manufacturing

Design outputs must be shown to satisfy all inputs through verification or validation, which shall be demonstrated through Trace Matrix.doc and coordinated with manufacturing goals according to the MasterValidationPlan.doc.

The trace matrix shall list all inputs in the Design Input and show by objective evidence that each need was satisfied by Outputs. The links that must be shown between outputs and inputs include Design Requirements, specifications, verification and validation results.

This plan and the Risk Management document shall be updated after design transfer and throughout the first six months of product sales.

That’s All, Folks!