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Why outsource requirements management?

Clear requirements

Experts who understand Requirements and international customers improves their quality and reduces non-validated assumptions. Poor requirements early in a project impact cost, schedule, and customer satisfaction.

Technical File Management including Requirements Management is a non-core task for design engineers and typically lacks focused attention. Delivered effectively, it increases efficiency in change management and enables documented reasoning for compliance within both product development and post-market surveillance.

Tooling and methodology

Industry best software tooling is expensive and evolving. Appropriate selection and tailoring saves license costs, also unnecessary process overhead.

Maintainable engineering changes

Deliver engineering changes easier with a single source of truth that is structured, complete and connected. Duplicated information or missing links/data increases risk plus wastes valuable time from the team.

Traced risks

Good product lifecycle management makes it easier to prove regulatory compliance, such as to the more rigid EU Machinery Regulation 2023/1230.

Where is your traceability at?

Paradigm shift

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Old: Simpler systems with fewer requirements from fewer sources
New: Systems with higher complexity and performance, and Industry 4.0

Old vs New paradigm

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Old: Information contained mostly in people’s heads
New: Need for documentation as too much information and higher staff turnover

Old: Limited product offering
New: Various evolving models and variants

Old: Team at one site
New: Team spread internationally

Old: Looser Directives from regulators
New: More prescriptive Safety Requirements from regulators

Old: Entire documents
New: Data entities

Old: Manual reviews and analyses
New: Software tools with AI or other automation that reduce manual work

Old: Single layer Systems Engineering V-Model
New: Agile/scrum, Model Based Systems Engineering, Systems Engineering V-Model

Old: Software tool silo’s per specialisation, silo's not 'talking', and data duplication
New: End-to-end traceability between the silo’s, and umbrella layer

Old: Software tools adapted for large OEM’s in the industry
New: Separated modules, customisation, integrations, more tool vendors

Team

Madeline

Madeline has worked in different regulated industries and countries for 15 years, bringing insight and flexibility to deliver what you need. A university-qualified Engineer from Australia (now Europe), she has enjoyed the ‘soft’ aspect of engineering, particularly organisation and compliance, as well as the cultural bridge. See LinkedIn for skill and qualification summary.

Partners and affiliates

We can work with a selection of functional safety specialists, software tool vendors or specialists, compliance consultants, and technical writers for their liaisons as required.

Interested in us to help you?

Service offerings

Technical documentation/file services, according to regulations.

Projects: Requirements Engineer for customisations from international market. Includes assessment and actions for Substantial Modification.

Enhancing software tooling (ALM, PLM, integrations) and/or methods.

How can you benefit?

My focus is to deliver concrete value to clients to foster efficiency and compliance

Poor requirements management can lead to:

1. Lack of confidence in meeting regulations.
2. Over-budget projects due to late issue identification and higher rework costs (after deployment: 50x- 200x).
3. Safety hazards from inadequate, incomplete or misunderstood requirements (a major cause of accidents).

Requirements Management (what is it) https://sebokwiki.org/wiki/Requirements_Management

Agile/Scrum https://agile-scrum.com/

ALM: software tool vendors have insightful blogs. For MBSE: https://mbse4u.com/blog/

PLM podcast https://www.youtube.com/@TheFutureOfPLM

Many tools vendors in this digital thread: tool summaries https://www.systemsengineeringtools.com/vendors-lists

Note: The different software tools can overlap in their functionality:
PLM with ALM, ERP with PLM, PLM with PDM, PDM with CAD, and ALM or PLM with Risk or Quality

Links for best practices

There is not a one-size-fits-all solution for a company