Mastering Document Control for Effective NPD

Stages of document control for effective NPDThere are five stages of document control critical to NPD and product management. If you have the digital tools that can define and maintain these controls across your organisation over time - then you have the foundations for a robust and auditable document management system that will maximise your company’s effectiveness and organisational capabilities.

So, what are the 5 stages of document control?

1. Document creation

“Creation is a gift to the future - Albert Camus

The creation of a document which will specify or design some key element of a product is the first stage in its life-cycle. But the way such documents are created (with drafts shared across multiple platforms) is often prone to mistakes and omissions. This can impact product quality or success later on. With various people responsible for commenting on and contributing to a document - it’s easy to miss important feedback, overwrite critical information and get lost in multiple drafts as it is shared and updated in real-time.

Email sharing is notorious for this kind of breakdown and Goolge Docs make it all too easy for new versions of documents to be created without others noticing. For documents to be effectively controlled as they are created, they need to be capable of being:

  • Stored in a secure, but accessible, central digital repository
  • Locked down for unauthorised editing
  • Open for review and comment only by nominated individuals
  • Owned by an individual who can approve or deny changes as required

Make the entire NPD process more efficient: from NPD to NPI with Cognidox.

2. Approval and publication

“Publish or be damned”, as the Duke of Wellington almost said.

The people using or approving documents will not always be those who were involved in creating them.

A good document control process ensures robust and consistent draft and issuance protocol so everyone can be confident about what is the final version of a file - and know what files they should be working from as they develop a product.

Documents need a way of being published so that proposals, designs and specifications can be easily and automatically shared across an organisation - but only when a business is satisfied they are correct.

Making publication to a wider audience contingent on approval is a major part of effective document control. In a paper-based system or typical file sharing app it can be difficult or impossible to set up workflows that standardises a method of approval and release for documents.

Good digital document control tools, on the other hand, will have automated mechanisms for publication, follow up and escalation, using digital notifications and alerts to ensure that no pending files are ignored or ‘go missing’ in the system.

For documents to be effectively controlled as they are published and distributed, document control systems need to have:

  • Mechanisms for approval and publication to an entire organisation or nominated individuals
  • Workflows created for standardised approval processes
  • Email reminders and notifications to keep documents flowing through the system
  • Capacity for ‘group publication’ of documents subject to approval of individual files

3. Change control

“Everybody wants to build and nobody wants to do maintenance.” - Kurt Vonnegut

In the document control life cycle change control is vital to contain the risk of serious mistakes or lapses in quality.

While the urge to tinker or upgrade to achieve better results can be keenly felt, keeping documentation up to date is often regarded as a bind and ends up being ignored.

But changes have got to be subject to a repeatable and consistent documentation process if they’re going to be effective and trackable.

Clarity in change control documentation is key to mitigate against misunderstandings in implementation and unintended consequences in end results.

For example, a change that makes perfect sense to engineering, regulatory, and quality departments may not be able to be manufactured without significant alterations to the automated machinery that will actually enact the change. Being able to catch this kind of potential problem is key to controlling future product failure and wasted effort.

Companies need a means of ensuring that every change requested for products or processes, is properly described and then approved by the right people in a standardised way to assess feasibility and likely impact. The implementation of the change then needs to be documented and subject to future review to ensure it has had the intended effect.

  • Use change control templates for standardised and comprehensive descriptions
  • Ensure proposed changes are circulated to all relevant stakeholders for approval
  • Automated follow up to assess success or failure of implemented change

4. Retrieval

“Pigeon holes will not do. Everything gets mixed in pigeon holes... I never know whether a paper is in A or Z” - George Eliot - Middlemarch

Great document control is not just about robust mechanisms for ensuring document security via strict hierarchies of access and permissions for download. It is also about the ease with which documents can be located and assessed for relevance and consulted when needed. This will help make your internal and external auditing processes much less onerous.

A common challenge for many businesses is workers being able to find documents when they need them. So, intuitive navigation, excellent indexing and meta-tagging tools are critical to any decent document control system.

Flexibility and sophistication in search functionality will make your document management system much more usable as a resource - and will encourage your workers to refer to it as a ‘single source of truth’ in everything they do.

For example, many workers want to search for information by simply typing in the terms they are searching for - but sometimes it’s more efficient for users to find the documents they are looking for by browsing an organized hierarchical structure.

Great document management and control balances the need for security and accessibility:

  • Hierarchies of access and permissions protect content
  • Meta tagging and indexing delivers intuitive navigation
  • Supports discovery by search term or browsing
  • The system facilitates best practice in document management and review - for frictionless internal and external audit.

5. Obsolescence

“Planned obsolescence is another word for progress.”- James Jeffrey Roche

Some documents, particularly, in regulated industry need to be kept in perpetuity to preserve the history of your product development for company knowledge sharing and auditing purposes. Other documents do not need to be stored so long, or may even have a statutory limitation on the amount of time they can be kept.

Once you have ensured your policy meets the minimum regulatory requirements, your system should help you use a risk-based approach to fix on reasonable retention times for various types of documents.

Obsolete documents can clutter your systems, making searching more difficult and unnecessarily impacting performance. Plus there are sometimes incremental storage costs to keeping unnecessary documents that could be controlled through proactive management like this:

  • Manage the performance of your Document Management System
  • Prevent unnecessary document sprawl and storage costs

Why is document control so important?

If you can effectively control and curate your product development documentation, then you will have a dynamic reference resource and a robust means of auditing your approach in the future.

But if you fail in the control of that documentation it can lead to organisational chaos, poor quality information sharing and no means of proving that products have been created in a way that meets their specifications.

This could make it more difficult for you to gain the commercial momentum you need, and even the regulatory permissions you require, to get to market.

Effectively controlling the lifecycle of your documentation is key to controlling the whole of your product development and management process.

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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