Sill silly silly
The Silly Device
Company
Released by:
Number And Rev:
QA Manager
OP 0401 Rev. 00
Originator:
Date Effective:
Work Instruction Name:
July, 1960
Quality
Design Control
1.0 Purpose
1.1
The design control process ensures that new products and processes are developed in an
effective manner with full consideration of the requirements of regulations, economic
effectiveness, and maximal functionality.
2.0 Scope
2.1
Design control spans all departments within the Company. Design control begins right after
the conceptual and testing stage or to improve a process. Design control ends when the
process or product has been transferred to production or approved by the Customer. Design
control is required for all products and for all processes that produce product. Design control
for processes is not required for maintenance or improvement of existing machinery.
3.0 Departmental Responsibility
3.1
3.2
3.3
3.4
Any department may initiate a project.
Any department may be responsible for supporting a project in design control.
The Quality Manager is responsible for all files and documents until the completion of the
project or cancellation. These documents are a Quality Record maintained by the Quality
Manager.
The Quality department is responsible for maintaining all files and documents required by
design control once the project is completed or canceled.
4.0 Definitions
4.1
4.2
4.3
4.4
4.5
4.6
DCPCS - Design Control Phase Completion Sheet
DCCS - Design Control Cancellation Sheet
FDR - Functional Design Review; a review held during design control. This is a controlled
document.
MDR - Management Design Review: senior management oversight review held during design
control
DHF - Design History File: The complete set of documents from all six phases constitutes the
design history file. experiments, qualifications, pilot runs, and validations as well as agendas,
reports, summaries, drafts, e-mail (hardcopy), and other informal communication records.
DMR - Device Master Record: All controlled output of the design process sufficient to specify
the device materials, dimensions, tolerance, manufacturing techniques, quality standards,
and related information. This includes all engineering drawings, specifications, SOPs, and
training materials.
Page 1 of 7
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Proprietary and Confidential
Sill silly silly
Released by:
The Silly Device
Company
Number And Rev:
QA Manager
OP 0401 Rev. 00
Originator:
Date Effective:
Work Instruction Name:
July, 1960
Quality
Design Control
5.0 Materials & Equipment
6.0 Procedure
6.1
Specific meetings and are required through the design control process.
6.2
FDR - At the end of phases two (2) through six (6) there is a Formal Design Review that
must include all team members. The reviewers examine the documentation of all items
identified for the phase have been completed and that all work is correct and complete. In
addition, all phase specific requirements are to be addressed. All reviewers must sign and
date the DCPCS for the phase to indicate acceptance of the results.
6.2.1
There is to be a list of all attached documents (and their authors) attached to the
documentation between the DCPCS and the documents.
6.2.2
Each team member is responsible for identifying any problems they identify in the
document package. Any concerns, ideas, comments, or suggestions should be
submitted in writing at the FDR for inclusion in the package.
6.2.3
When it is not possible for a team member to attend a FDR they may inspect the
completed documentation package within one week of the FDR or send a delegated
staff member.
6.3
MDR - the go/no-go sign-off on the DCPCS performed by senior management occurs after
each Design Review. If management decides to cancel the project, they create a DCCS.
After management review is complete the documentation package assembled during the
phase it is filed by document control as part of the design control package with either a
completed DCPCS or a completed DCCS.
6.4
Design Control is a six step process: Discovery and Feasibility, Design Input, Project
Definition, Design Output, Pilot and Verification, Validation.
6.4.1
6.4.2
6.4.3
6.5
For products that are simple modifications of existing products (Level A
modifications only) the process may be collapsed into three steps: Design Input,
Design Output, and Verification & Validation.
It is possible to split a project into multiple sub-projects.
All subproject decisions and changes must be approved by senior management.
Phase 1: Discovery and Feasibility
6.5.1
6.5.2
6.5.3
At this phase a product or solution which is considered promising is proposed
formally. The proposal can be initiated by any employee.
Upper management must approve this proposal so that the project can move into the
next phase of design control.
When the report is approved a copy is provided to the Quality Department.
Page 2 of 7
Last printed 3/8/2016 9:04:00 PM
Proprietary and Confidential
Sill silly silly
The Silly Device
Company
Released by:
Number And Rev:
QA Manager
OP 0401 Rev. 00
Originator:
Date Effective:
Work Instruction Name:
July, 1960
Quality
Design Control
6.5.3
6.5.4
6.5.5
6.6
The Quality Department will issue a unique identification number for the project. This
number is to appear on all DCPCS, the DCCS (if the project is canceled), and all
reports prepared over the course of the project.
The assignment of a PS number is what separates ideas from projects. The signed
proposal and the PS number are filed as the Phase 1 documents.
Senior management then appoints one person as the Project Manager.
Phase 2: Design Input.
6.6.1
6.6.2
6.6.3
6.6.4
6.6.5
From this phase on special attention must be paid to regulatory
requirements and adequate records for the DHF. These
documents are to be maintained and become part of the DHF.
The Project Manager is responsible for choosing the members of
the Project Team. At the minimum a new product team should include members from
engineering and quality.
The project team must be approved by senior management.
Project Manager Responsibilities
6.6.4.1 Document the project resources required, duration, cost, and potential
complications.
6.6.4.2 Initiate required searches for patents, trademarks, and copyrights.
6.6.4.3 Establish A Project Name
6.6.4.4 Write a Project Charter - everyone must approve and sign.
Strategic and Tactical Issues:
6.6.5.1 Competitive Analysis
6.6.5.2 Marketing Analysis and Planning
6.6.5.3 Strategic and Tactical Alignment
6.6.5.4 Financial Expectations
6.6.5.5 Design Inputs by Function (and examples). Design input is the collection of
requirements for the product or process. Design input should include all the
things necessary to verify that the product or process transfers at the end of
design control without unexpected problems or missing information.
6.6.5.6 Management Inputs (costs, leads, inventory levels)
6.6.5.7 Engineering and R&D Inputs (performance specs, materials, equipment).
This includes a formal testable performance specification.
6.6.5.8 Sales and Marketing
6.6.5.9Purchasing Inputs (specification requirements, vendors)
6.6.5.10Quality Inputs (testing and documentation)
6.6.5.11 Production Inputs (process instructions, training)
6.6.5.12 Operations Inputs (planning, project transfer)
6.6.5.13 Logistics Inputs (receiving, inventory control, tracking)
6.6.5.14 Information Systems Inputs (databases, access points).
6.6.5.15 Maintenance Inputs (preventative maintenance, Installation)
6.6.5.16 Regulatory Input (safety, clinical testing, stability, Packaging, labeling, and
qualifications)
6.6.5.17 Risk Benefit Analysis (AS APPROPRIATE ONLY)
6.6.5.18 Customer Supplied Input
Page 3 of 7
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Sill silly silly
The Silly Device
Company
Released by:
Number And Rev:
QA Manager
OP 0401 Rev. 00
Originator:
Date Effective:
Work Instruction Name:
July, 1960
Quality
Design Control
6.7
Phase 3: Project Definition
6.7.1
6.7.2
6.7.3
6.7.4
6.7.5
6.7.6
6.7.7
6.8
Failure Mode and Effects Analysis is recommended.
All team members must sign off on the FMEA.
No team member shall sign off on the FMEA if they have concerns about missing or
underrated risks. This FMEA must address the concerns of all team members to their
own satisfaction.
This FMEA is a living document and will be maintained and extended over the course
of the project.
The project budget are formalized in this phase for senior management review and
sign-off.
A project GANNT may be created using design input and FMEA results for guidance.
All tasks identified in phase 2 must be on the GANNT, as well as all testing identified
in either the design input or the FMEA.
The phase ends with the successful completion of the FDR and MDR. Successful
completion of the MDR phase allows the Project Manager to perform necessary
scheduling of resources and budget without delays.
Phase 4: Design Output
6.8.1
6.8.2
6.8.3
6.8.4
6.8.5
6.8.6
6.8.7
6.8.8
6.8.9
The primary emphasis of Phase 4 is the design of the processes (and products). The
output of this phase is a complete DMR with all documents released at draft level.
Until the documents are released in draft, no PQS testing may be performed and
testing can be done only under EDC. EDC tests may be used to support conclusions
but are not acceptable as qualifications or validations of any process or product.
The tasks identified in Phases 2 and 3 are to be performed as assigned in the project
GANNT to support the other activities necessary for transfer.
Each output must be verified against the design input(s) which is(are) applicable.
This verification is documented in a report and must show that the DMR as a whole
addresses all of the requirements of the phase 2 specifications.
The FMEA must be updated to take into account the DMR items and determine what
additional work must be performed beyond that required by the design input.
If a large number of items are discovered, This updated phase 2 package is identified
as “revised design input” and becomes part of the record for this phase.
A plan for the steps in pilot production, which identifies the requirements at each
step, should be developed. This plan is used to guide the process or product out of
the lab and into pilot production and eventual transfer.
It is now possible to create a checklist for use in the final phases. The list should
include all the verifications required, all equipment and process qualifications
required, and all validations required.
A list is made of all Phase 4 documents and authors. This list is used during the
design review as a checklist to make sure that all required reports are present and is
then included in the documentation package.
Page 4 of 7
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Proprietary and Confidential
Sill silly silly
The Silly Device
Company
Released by:
Number And Rev:
QA Manager
OP 0401 Rev. 00
Originator:
Date Effective:
Work Instruction Name:
July, 1960
Quality
Design Control
6.8.10 The phase ends with the successful completion of the FDR and MDR. The FRD team
is the project team.
6.9
Phase 5: Pilot Production/Implementation.
6.9.1 The project is moved into pilot production or test implementation before validation to
ensure conformance with design requirements. Final engineering and/or IS
refinement occurs until all pilot runs identified in phase 4 end successfully. Any
issues which arise during the pilot runs are documented and resolved or formally
postponed.
6.9.2 Many projects will spin-off a number of small projects. The status of those projects
does not affect the progress of the current project unless the successful completion
of the spin-off is necessary to complete validation.
6.9.3 A plan for the transfer of the project on final acceptance is to be developed and
documented.
6.9.4 Revision of documents in the DMR should be performed as process learning occurs
in pilot production. The draft level should these documents should be updated as
necessary to maintain proper tracking and recording of learning.
6.9.5 At the end of this phase all documents should be of release quality and ready for
submission for approval. Each of the final documents is to be verified against the
design input and the FMEA to ensure that project drift has not occurred and that all
requirements are being met.
6.9.6 A list is made of all Phase 5 documents and authors. This list is used during the
design review as a checklist to make sure that all required reports are present and is
then included in the documentation package.
6.9.7 The phase ends with the successful completion of the FDR and MDR. The FRD
team is the project team.
6.10
Phase 6: Validation
6.10.1 This phase closes the loop on all issues of validation and documentation to satisfy the
needs of all departments and the requirements for design transfer.
6.10.2 For each part of the design or solution to be validated the relevant documents must
be submitted for document control and approved. The finalized versions of all
documents in the DMR must be released prior to the conclusion of this phase.
6.10.3 The documents in the DMR must each have a supporting validation or qualification
that demonstrates not only compliance with regulation but also satisfactory resolution
of the issues in the FMEA.
6.10.4 Once the necessary qualification or validation is completed the affected documents
are to be submitted to document control for release approval.
6.10.5 Each of the FMEA categories should be discussed in a summary report on the
methods used to manage the risks identified with specific reference to the DMR
items that were developed. All deficiencies must be corrected before the FDR.
Page 5 of 7
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Proprietary and Confidential
Sill silly silly
The Silly Device
Company
Released by:
Number And Rev:
QA Manager
OP 0401 Rev. 00
Originator:
Date Effective:
Work Instruction Name:
July, 1960
Quality
Design Control
6.10.6 Each team member contributes to a project learning report. The purpose of the report
is to capture the team experience with the project, the design control employed, and
the methods of communication and record employed. This report is to be kept with
the applicable revision of the design control procedure as part of the record of project
management learning. The project manager maintains a copy and a copy is kept as
part of the DHF. Each team member is to receive a copy as well.
6.10.7 A list is made of all Phase 6 documents and reports and their authors. This list is
used during the design review as a checklist to make sure that all required reports
are present and is then included in the documentation package.
6.10.8 When completed, the full package of documentation and support data is assembled
into a project package and submitted for final approval at a design review meeting.
This submission cannot occur until all SOP, work orders, forms, specifications and
drawings are in document control and issued, which means that every and all
validations are completed and approved.
6.10.9 The phase ends with the successful completion of the FDR and MDR. The FRD team
is the project team.
7.0
Project changes and ambiguities.
7.1
7.2
7.3
7.4
7.5
If a project description needs to be changed, and any item from any phase already completed
will be affected, then senior management must decide between canceling the existing project
and starting a new one with the revised description OR formally changing the project
description.
If management elects to cancel the project and start a new one the work performed for the
original project may be re-used if it is still relevant and sound evidence can be presented to
justify re-use.
If management elects to redefine the existing project then the team must be allowed time to
work through the items identified in phase one (1) forward in order to assure complete and
correct conformance with each requirement of this procedure.
When there is a problem with incomplete information or ambiguous definition the problem is
to be solved systematically. Similarly, when there are conflicting requirements or
contradictory definitions the problem must be solved in a complete and systematic fashion.
The team is responsible for developing one or more solutions and documenting them in a
report. If the team agrees unanimously an a single solution the report must reflect this, and
the team members sign the report to show assent.
If the team is unable to find a unanimously acceptable solution then the difficulty must be
documented in a report drafted by a team member, to be chosen by the Team Leader. The
team then reviews this report. The team is responsible for documenting the alternative
solutions to the problem (or the lack of any solution which is acceptable). These are added to
the report along with the necessary supporting documents. This package is signed by each
team member and given to the project manager. The project manager is responsible for
selecting one of the solutions in the report, suggesting alternatives, or consulting with senior
management to review the problem. Once a decision is made it is to be documented in a
signed memo. The memo is copied to every member of the team. A copy of this memo and
the report are placed in the documentation package.
Page 6 of 7
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Proprietary and Confidential
Sill silly silly
The Silly Device
Company
Released by:
Number And Rev:
QA Manager
OP 0401 Rev. 00
Originator:
Date Effective:
Work Instruction Name:
July, 1960
Quality
Design Control
7.6
8.0
A phase cannot be completed until all ambiguities, contradictions, or related problems are
resolved and documented.
Format of DCPCS and DCCD
8.1
The DCPCS must contain the following (at minimum): Title (DCPCS), Internal Project Name,
Phase, Date, Name and title of each reviewer present at the meeting. Below this the following
text, “Reviewer’s signature and date signifies acceptance of documentation package. Signer
has inspected all work presented, finds it satisfactory and complete, and recommends that
the project proceed to the next phase.”
8.2
The DCCS may be formatted in any manner provided it Project Name, Phase, Date, Reason
for cancellation, followed by the name and title of all senior managers with signature and date
space DCCS and documentation are filed in document control.
8.3
Projects begun under previous versions of design control are to be transitioned to this
revision after the effective date. This grandfather clause is intended only to encourage
continuous learning about design control so that the design control process can be revised
regularly without stopping existing projects.
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