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What is document lifecycle management & why does it matter?

documents lifecycle-1What are the 7 stages of the document lifecycle?  Why is managing and controlling the lifecycle a critical part of a Quality Management System (QMS)?

What is the document lifecycle?

Document lifecycle: the stages a document goes through as it is issued, distributed and used in an organisation, from its creation to the moment it is archived or deleted.

What are the stages of a document’s lifecycle?

Document lifecycle can be broken down into 7 key stages

  1. Creation
  2. Approval
  3. Storage
  4. Distribution
  5. Retrieval
  6. Change control
  7. Obsolescence

Document Management and Document Control: Is there a difference?

What levers do you need for effective document lifecycle management?

Document controls are the procedures and tools you’ll need for managing each stage of a document lifecycle successfully. 

Why does document lifecycle management matter?

Without the right controls in place across the document lifecycle your business risks losing vital data and organisational knowledge as it grows and changes.  You face an increased risk of ‘document anarchy’.  And you risk failing to comply with key standards and regulations. 

Why is document lifecycle management important for compliance?

Document lifecycle management is a critical feature of the quality management requirements specified in ISO 9001 and ISO 13485 (for medical device developers). These are the standards that ensure the integrity of data and information through a product’s stages of maturity from ideation, design, manufacture to maintenance. These are the standards that control the quality and consistency of your output. They secure the safety and efficacy of the products you supply.

Why you need to control the 7 stages of the document lifecycle:

1. Creation

Without control over who can add documents to your system you risk losing accountability and traceability around your process and projects

Who authored and approved your Quality Manual? Who defined the SOPs outlined in your QMS?  Are these documents set up, signed off and owned by people with the appropriate authority and qualifications?  Effective document lifecycle management gives you and future auditors confidence about the provenance and authority of every document in your system.  It ensures the reliability of the documents you use everyday to design, manufacture, test and release your products.

2. Approval

You need the tools to approve documents prior to use so mistakes are captured and corrected.

If you can’t select individuals to review and approve documentation for finalisation, you risk releasing incomplete/inaccurate documents that can damage your business or lead to dangerous mistakes.

Remember when the UK government released a multi-million pound ferry contract with Ts and Cs obviously cut and pasted from a Domino’s pizza site? Or when the French national rail operator RFF gave the wrong dimensions for a required new fleet of trains that were too narrow for their platforms?  That mistake cost RFF 50 million Euros to correct.  Or what about mistakes made in the labelling and packaging of medical devices?  At the turn of the last decade, 15% of FDA medical device product recalls were down to misleading or incorrect labelling, the result of failed document approval mechanisms. 

3. Storage

You need to protect vital customer data, products and business intelligence from loss or misuse

Security issues are all too common in organisations holding sensitive data. From the data leaks that affected three billion Yahoo customers in 2014 to the strange appearance  of a stash of top secret MOD documents at a bus stop in 2020.  Many bodies and millions of people are affected by lax document control every year.  

Protect your workers, customers and your IP by securing your systems and developing procedures to mitigate against human error.

4. Distribution

You need the tools to publish and share the right documents at the right time to keep your organisation efficient and effective.

If you can’t selectively publish and share documents with colleagues and third parties you can’t effectively control the flow of data and knowledge in your organisation. You risk chaotic project management, security and other lapses.

Controlling document flow is a key part of an effective and LEAN product development process.  Releasing the right documentation to the right people at the right time in a process prevents wasted time and effort.  It keeps teams focused on minimising extraneous and confusing documentation, delivering exactly what they need to, at every point of the development cycle.

5. Retrieval

You need to ensure the retrieval of data and information is fast and efficient. 

Both ISO 9001 and ISO 13485 require documents to be readily available for stakeholders at the point of use.

If you can’t retrieve information from a document system quickly and easily when you required hours and days can be lost to projects and vital business intelligence can be overlooked.

Ensuring your business is indexing documents with metadata can help your team find the documents they need when they need them.  It can help prevent the loss of organisational knowledge and data in the black hole of a sprawling system.  It can prevent you having to duplicate work, or proceeding with projects without having the right data or evidence in place to justify critical decisions

6. Change control

If you can’t control how and by whom changes  are made to documents you risk mistakes going unchecked, unauthorised work being done  and projects growing out of control.

Who’s made changes to a document? Are developers working in a silo adding new functionality without authorisation?  Has a potentially dangerous change to a medical device been authorised without input and approval from a cross functional team?  Mechanisms for controlling engineering updates, as well as Corrective and Preventive action (CAPA) ensure critical changes are scrutinised and approved by the right people before they can go ahead.

Effective change controls are the commercial and regulatory circuit breakers you need to protect your business from waste and mistakes.

7. Obsolescence

If you can’t control when and how documents are made obsolete you risk accidental document loss that could result in fines from regulators or a system stuffed with unneeded documentation. 

ISO 9001 and ISO 13485 require that you can easily tell what is an obsolete document and what is the most current version of the documents in your system.  This prevents wasted time, confusion and mistakes.  At the same time you need to be able to archive your documents and keep them available for as long as the law requires(without slowing down the performance of your system or costing the earth in storage fees).  

Choosing a document management system (DMS) with the tools to control the entire document lifecycle will help you build a quality system that can meet your organisational objectives and your regulatory obligations.

Look for flexibility in your eQMS

But great document lifecycle management is about having the levers to implement document controls as required without unnecessarily interfering with the flow and velocity of your development process. 

The danger of ‘overprocessing’ is ever present for start ups and SMEs. Many of these businesses choose heavy duty eQMS (as used by the largest pharma companies) to guarantee their compliance with quality standards.  But the level of controls and checks that these systems impose on your documentation and process from the outset can slow down a small operation without good cause.

Not every document requires the highest levels of controls to be applied to them, different documents may require different approval journeys and will have different archiving requirements. 

Choosing an eQMS flexible enough to scale with you and ramp up document controls as needed can give you the flexibility you need to grow quickly and efficiently.

Choose Lean tools for Document lifecycle management 

The good news is you can build a quality management system that controls your documentation adequately throughout its lifecycle while not tying you up in red tape or slowing you down unnecessarily.

For this you need the LEAN document management tools that can help build out your own workflows and approval mechanisms in a way that makes sense to you, reflecting the maturity of your organisation and the level of risk your operation faces.  These are tools that bring exactly the right level of control to your company while reflecting the way your business wants and needs to work.  

 

How to build your Med Tech eQMS

Tags: document management system