Effective Change Control Process: Key Strategies for Success

What does a good change control process look likeA change control process is a vital part of any product development and management function. But if it’s not enforced rigorously enough it can lead to costly mistakes, inefficiencies, and even regulator penalties. At the same time, if the process is too complicated and onerous it will likely fall into disuse and cause even greater chaos.

Companies report that change control is a frequently mishandled part of their product management lifecycle. Indeed, a research study by the Aberdeen Group found that 85% of companies believed their change management procedures are either broken or could be improved.

But what are the tools and approaches you can adopt to make sure change control is serving your business effectively?

What’s the point of change control?

Having the ability to change plans, correct errors in design or otherwise optimise a product’s functioning, is essential for any company developing new products and managing an existing portfolio. It ensures money is not wasted on manufacturing designs that will not work or might malfunction; it protects companies from making investments in designs that are likely to fail.

After a product is launched, these controls should also ensure there is a formal way to capture and expedite changes resulting from customer feedback. This post launch capacity for change is an absolute requirement for some highly regulated sectors (such as medical device development, pharma and automotive), for whom CAPA (Corrective And Preventative Action) plans are evidence of a proactive and fit-for-purpose Quality Management System (QMS).

Good Document Management is at the centre of change control

However, the ability to do all of the above effectively, really starts with having complete control over documentation from the outset of a project.

The most efficient and effective companies will have a digital Document Management System (DMS) in place to assemble, store and secure their plans and designs properly while making them accessible to an entire product team at every stage of a product lifecycle.

This DMS should be the foundation on which the whole product development process is built, and the place from which the entire change control mechanism is triggered, tracked and recorded.

Develop a formal process for change management

The Aberdeen Group report found that the best performing companies were 70% more likely than their competitors to have a formal process in place for implementing engineering changes supported by digital tools.

This is an agreed way in which required changes are flagged and dealt with in a series of required steps. These typically include:

  • The submission of a documented change request (CR)
  • A formal assessment of the request (including time estimates, cost benefit analysis etc)
  • Planning and design processes
  • Solution implementation and testing
  • Documentation of change
  • Results tracked and effectiveness analysed

The ideal way to ensure this happens is by setting up workflows within a digital Document Management System. With the right DMS, the workflow can prompt email notifications for key stakeholders to review and comment on requested changes, before fresh technical documentation is issued for which approval is sought. Once digital approval has been gained from all parties, changes can be implemented, new issues of documents released, and records updated to show changes have been made.

Having these kind of document led processes in place ensures that important change requests are not ignored - that each one is evaluated properly and that any required change is correctly scoped, interpreted, implemented and then recorded.

Lose the endless meetings - proceed more quickly

A process like this, managed automatically via a digital platform can bring significant benefits to businesses who need to move quickly to satisfy customer demand and beat competitors to market.

It can end the bureaucratic nightmare of a change process with twenty or more steps, requiring numerous cross departmental meetings to reach agreement. It can eliminate all the wasteful actions involved in traditional change management without losing any of the necessary sense checks and reviews they were designed to offer.

Digital DMS tools improve decision making and change outcomes

The Aberdeen Group report also found that the better the quality of supporting documentation and data included in the change request, the better the commercial outcome of the request promises to be. The inclusion of CAD files, BOMs (Bill of Materials) and other detailed files within a CR makes it easier for a team to see the potential impact of the proposed change and judge whether or not to proceed.

Digitising this and other processes can make for much better informed teams and more seamless and efficient decision making. The Aberdeen Group report found that the most successful teams had centralised access to the entire change history of their product, including access to each individual change status and approval. With this kind of transparency businesses can make their teams more collaborative while reducing time-wasting and the duplication of effort.

Overall, the ABG group found that the best and most effective companies in the product development space were those who used software to manage engineering change which provided centralised design information, traceability across deliverables and management of the change workflow.

Digital change control tames the chaos

Informally managing engineering changes to products by email or in side-meetings between business managers and developers (although sometimes tempting) is clearly a recipe for chaos.

Instead, all the evidence shows that those taking a structured approach to change management, supported with the right digital tools can make for better decision making and implementations that really make a difference.

However, it’s vital that companies choose tools that won’t drive them to a halt through excessive bureaucracy and destroy the momentum of their product development processes.

Good engineering change control should be a function of a robust and simple DMS - a DMS designed to make governance of your entire product development cycle efficient, transparent and intuitive.

The value of DMS for Product Development


Tags: Document Management and Control

Joe Byrne

Written by Joe Byrne

Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and fortune 500 companies, Joe has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices and product development, Joe is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigour.

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