10 Reasons Fabless Semiconductor Companies Need Document Control

why semiconductor companies need a document control system

With complexity and costs rising, fabless semiconductor companies need to do all they can to keep their flow and focus. They need to minimise the risk of product failure and retain investor confidence as they move towards launch. But how?

Increasing challenges and rising costs in the semiconductor market are well documented.  

“As chips get smaller, R&D becomes more challenging as researchers deal with quantum effects, minor structural variations, and other factors that can complicate development. Designing a 5 nm chip costs about $540 million for everything from validation to IP qualification. That is well above the $175 million required to design a 10 nm chip and the $300 million required for a 7 nm chip.”


Unsurprisingly, juggling these competing demands means document anarchy can be a constant battle for innovative and rapidly scaling development houses.

To keep big and expensive SOC (system on chip) projects on track, these companies need complete control over the way documents are handled - from requirements gathering to the moment designs are released to manufacturer. From ‘tapein’ to ‘tapeout’, they need to ensure documents are kept secure, formally reviewed, approved and released before use if they’re not going to risk omissions, mistakes and expensive corrections.

Download our free guide to Document Control for Fabless semiconductor companies

Scaling semiconductor conductor companies struggle with governance

Yet many teams spend years struggling with a lack of governance before deciding to formalise their document controls within an electronic quality management system (eQMS) and gaining ISO 9001 compliance. Other developers, working on chips for the automotive industry, make the move to a formal QMS in order to specifically meet the demands of the functional safety standard ISO 26262.  

It can take a lot of pressure for semi-conductor companies to decide to take that leap.  Companies are often worried that another layer of cost and admin will only add unnecessary bureaucracy to their businesses. But those who do invest in formal document control systems and ISO compliance can discover new opportunities for optimisation that transform their productivity and the pace at which they can work.

Document controls imposed with the right software system can help you marshal your processes to deliver the right quality results. They can keep you laser-focused on customer needs and enable you to continually improve the quality of your output. Automating these processes with the right software can cut the risk of process gaps, delays and mistakes while helping you optimise your entire process

10 reasons your fabless semiconductor company needs a document control system

1. Security

Managing a digital hierarchy of access control is critical to ensuring that everyone in your organisation has secure and rapid access to the material they need to do their job. You need the right people to be able to find and share data easily, but you also need to keep sensitive data and IP safe:

“Formulas, source code and other IP can be prime theft target in chip development.  Design information in CAD files can be harder to protect than structured data. Implementing best practices, including encrypted transmission uploading and rigorous user authentication, is critical.”

Rich Baker at Protolabs

2. Review and approval capabilities 

The right document management system ensures that authorised people in your organisation can review and approve documents before they are distributed for use. An eDMS can automate approval requests from multiple stakeholders, then notify the teams who need to use them whenever documents are released or updated. This ensures that everyone in the business is always on the same page and using the latest and most up-to-date versions of business documents to work from. It increases the speed of development and prevents wasted time working on obsolete documents.

Advanced document approval control will also help you establish phase gates, formal STOP/GO moments in your product development process at which groups of stakeholders can review progress against deliverables and decide if projects are still commercially viable. These high levels of document control are the circuit breakers that ensure you don’t waste time and money as you manage high-value projects.  

3. Change control 

Document change control prevents scope creep, unauthorised work, and costly mistakes. The right automated process helps you ensure change requests go through required sequences of scrutiny by key stakeholders before they are accepted. The nature of these changes and who approved them will then be instantly recorded as part of your audit trail. When changes are made they can be automatically reviewed by key stakeholders at a later date, to ensure they have had their intended effect. 

4. Discoverability 

Being able to find documents quickly and reliably increases the velocity and flow of any development process. Ensuring your team can easily access your QMS and find SOPs or training documents will make it easier for you to maintain best practice. Indexing documents with metadata makes your system highly searchable, linking documents and data in ways that ensures knowledge is protected and available where it is most relevant. 

5. Controlling workflows for tapeout data

One of the major challenges of the tapeout operation in chip design is managing complex workflows and checklists among internal and external stakeholders. 

Failed taped out designs can result in costly mistakes. An effective tapeout process is key to avoiding late error discovery and resulting financial hits. Every step of the workflow generates data and potential actions, so having complete control over who sees what and when is critical to managing an orderly and effective process.  Automating IP and final validation checks ensures the efficiency, data integrity, manufacturability, and on-time delivery of your data. Does your system deliver this level of control?

6. Design Release to your fabrication partner

When your design is finalised you’ll have a complex set of documentation that you then need to transfer to your fabrication partner (typically located in Taiwan or China. If you make a mistake in the transfer of this design documentation it can be a multi-million dollar mistake. The right document management system builds in processes so these errors cannot happen.

7. Managing product release to paying customers

Some document management systems allow you to licence product release sets to customers and then track when those customers have accessed the product release sets. These systems can also automatically restrict access when a licence is not renewed.

11 myths about ISO 9001 - busted!

8. Version control

Your system should make it very clear which is the latest and approved version of each document in your system so confusion cannot arise. Documents should be labelled clearly and watermarked showing when they are drafts, approved or superseded versions. You need the ability to automatically archive documents when they are obsolete while retaining them for future audits. This level of control will help you keep your system uncluttered, making navigation easier and preventing future mistakes.

9. Continuous improvement 

The right document controls help you build processes to continually review the way you deliver quality and best practice, customer satisfaction and commercial performance.  Having the right document controls in place will help you build and automate the cycles of Plan, Do, Check, Act (PDCA) required by ISO 9001 across your organisation. These are the processes intended to lead to continual improvement in the way you work. 

For example: 

PLAN: to introduce new processes - document project requirements 

DO: Manage new process implementation - assign ownership & track project progress 

CHECK: Document results and schedule review of outcomes 

ACT: Collaborate to fix issues and manage any remedial action 

This model can be applied to every part of your Quality Management System to incrementally improve the quality of everything you do, from product design to your corrective action process and post-market surveillance activity. 

10. Auditing 

If you have the right level of document control in your system, auditing will become a much simpler process. The right software system will automatically capture and record the changes that have been made and approved in the documents you manage. Capturing these details will help external auditors understand every decision-making process that you have gone through and how you have managed change control. They will also help you in your internal investigations when you need to identify the root of non-conformity to deliver corrective and preventive action. 

Can your controls be right-sized to your needs? 

Yet it is true that document controls can add to the bureaucratic burden of an organisation. And if document controls are being imposed excessively and without good reason, they can quickly become a drag on your operations.  

In fact, ISO 9001 encourages developers to be LEAN in their approach to process and documentation in order to be as effective and efficient as possible when it really matters.

“A QMS should maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned.” 

Finding a document control system that is flexible enough for you to impose the level of control you need, but can scale with you as your governance demands grow - is key to success in the semiconductor industry.  

Choose a system made for semiconductor development

The pressures on fabless semi-conductor companies to control their processes are unique. As a result, off-the-shelf quality management systems too often miss the mark.  They can be too prescriptive in the way they define processes, while not giving enough scope to impose design controls in the way that works for them.

As Iain Stacey formerly of chip and software development house Display Link points out, 

“At different stages of our development flow you might have different types of processes that you run. For example, in the early stages of a project, you can be pretty agile, as the chip and firmware guys help you iterate a solution. But then as you get into the back end of the chip design you have to go more ‘waterfall’ because there has to be a certain set of fixed flows which you can’t iterate around. You need a document management solution that gives you that flexibility’.

Are your document controls as robust and flexible as you need them to be? Choosing a system built by and for fabless semiconductor developers may just be the solution you’re looking for.

Cognidox Med dev Fabless companies

Tags: ISO 9001:2015, Document Management and Control, Fabless Semiconductor Design

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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