In-house design capability: establishing a design-development system for ISO 9001 certification
Before founding Frugal, Tom designed and implemented the systems, controls and supporting documentation that established Thorworld’s in-house design-development function and supported the successful extension of ISO 9001 certification to design and development.
Early career project
Design systems
ISO 9001 design development
Example records from the design control system
Situation
A manufacturing business with established production capability wanted to bring more substantial product development in-house. At the time, Thorworld’s quality system covered manufacture, but not design and development.
Establishing an internal design function required more than appointing a designer. The business needed a workable design-management system that suited its size and operations, integrated with the way information was already handled and could stand up to external audit.
Tom was tasked with designing and implementing that system, together with the documentation, records and controls needed to make it work in day-to-day product development.
The real problem
The challenge was to turn ISO 9001 design-development requirements into a practical operating system for product development, rather than merely add procedures to the quality manual.
The new process needed to define how projects would be initiated, how design inputs would be captured, how reviews and approvals would work, how changes would be controlled, how outputs would be defined and released, and how verification, validation and compliance evidence would be retained.
Legacy design information also had to be brought under control, new templates and records created, and the system integrated with the company’s wider costing, planning, stock and project-information processes.
Constraints
Practical as well as compliant: The system needed to be robust enough for certification but straightforward enough for a modest-sized manufacturer to use consistently.
Built from first principles: The company had established manufacturing knowledge but no existing formal framework for managing in-house design and development.
Integrated with business operations: The process needed to align with existing documentation, personnel responsibilities and stock, costing and project-information flows.
Legacy information: Historic design data and existing product knowledge needed to be transferred into the new system in a controlled and usable form.
Audit-ready from the outset: The process and records needed to support review by the external QMS consultant and subsequent certification audit.
Client:
Thorworld Industries (opens in a new tab)
Role:
Design Engineer
Period:
2005–2007
Scope:
Design-development system setup +
QMS process definition +
Templates, records, and project controls
Acceptance basis:
ISO 9001 design-development reqs +
External QMS consultant review +
Successful certification audit
Key moves
Put the right design toolchain in place
- Reviewed the limitations of the company’s existing 2D Autodesk Mechanical Desktop setup as a basis for internal product development
- Compared alternative 3D CAD and structural-analysis platforms, then recommended and implemented SolidWorks and Multiframe 4D as the new core platforms
Define a workable design-control model
- Wrote the company’s design-development approach into the QMS, translating ISO 9001 requirements into a practical internal operating model
- Defined a clear distinction between validated standard-product baselines and controlled special variants, so the level of review and technical documentation matched the extent of change
Build a design-control system for live design work
- Designed and coded an MS Access / VBA-based design-development planning system to control projects, records, and technical-file creation
- Structured it around planning, review, change control and evidence retention, informed by BS 7000, ISO 9001 and ISO 10007
Capture the technical file as the design develops
- Put in place a workflow that captures sketches, calculations, and early-stage development work as the work is done
- Ensured that concept development and supporting reasoning were retained within the technical file rather than lost once products reached release
Bring legacy information under control
- Planned and delivered a prioritised transfer of existing design data into the new system, improving file quality and consistency as it progressed
- Used that migration not just to copy information across, but to review and strengthen the technical-file baseline for standard products
Prove and refine the system through live use
- Used early in-house development projects to test and tune the software setup, templates, workflows, and interactions with costing, planning, and stock systems
- Worked with the company’s external QMS consultant during implementation, then supported the first external ISO 9001 audit of the new design-development function
Outcome
Tom designed and implemented a working in-house design-development function, covering the software toolchain, QMS process, project controls, technical-file records and release arrangements needed for controlled product development.
The system was adopted into live use, integrated with the company’s wider operations and taken through its first external ISO 9001 audit for design and development. The audit raised only one minor comment, with no discrepancies or major issues, confirming that the new function and its supporting controls had been established on a sound footing.
What this enabled
The business extended its ISO 9001 certification from manufacture into design and development, where its previous ISO 9002 certification had covered manufacture only.
This gave the company greater internal capacity, flexibility and control over product development. It created a practical basis for improving existing products, developing new catalogue products and using external specialists more selectively where additional expertise was required.
First audit outcome
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