Inadequate document review is often to blame for failure in new product development and manufacturing processes. But what can you do about it?
Badly managed document review procedures can result in errors going unchecked and work within busy teams being unnecessarily duplicated. At the same time, projects progressing without regular review and oversight of documentation can cause:
- Designs to be mis-specified
- Required changes to be missed or ignored
- Products to be delivered late or over-budget
- Products to be delivered against the wrong specification
- Quality processes to break down altogether
In the worst-case scenarios it can result in damaging commercial failure and regulatory sanction.
Here are 4 ways improved document review practices can keep projects on track and reduce the risk of breaches in quality and compliance.
Effective Document review procedures ensure:
1. Proposed releases of key documents are agreed on by relevant stakeholders before critical actions are taken
Gathering approvals from key stakeholders before documents are released or updated is key to ensuring
- Products are properly specified,
- Change management is handled correctly.
- GxP is properly defined and observed
Good document management systems allow feedback to be gathered in formal workflows and appended in a systematic way for actioning by the right people. In effective document review processes no changes are made unless approval from relevant stakeholders is formally given and recorded. Through automated document routing, notifications, follow-up and escalation, the right digital document management system ensures that vital feedback is not omitted, and mistakes are corrected before final versions of specs and quality documentation are released.
The ability to group documentation together for collective release and publication post-approval is an important part of any stage-gate process. But it’s difficult or impossible to achieve this without the right digital tools.
2. SOPs can be checked regularly for accuracy and updated accordingly
SOPs should be subject to regular review by stakeholders through automated workflows. That way companies can ensure they correctly reflect best practice, the latest regulatory requirements and what’s actually happening on the ground. Sometimes, a routine review of SOPs against the tasks as performed, will show up where the reality is falling short of expectation. At other times, processes may have been changed or updated, but those updates not captured in the written documentation.
Implementing formal review procedures for SOPs can transform ad hoc, piecemeal oversight activity into repeatable, documented business processes that safeguard organisations from failure, and help foster a culture of continuous improvement.
3. Workers can be sure they are always using the latest version of documents
One of the major issues around the way document review is handled is the propensity for mislabeled and different versions of key documentation to proliferate on servers, confusing those who need to find and refer to them quickly and efficiently. Digital tools that control document review and change processes ensure this kind of ‘document anarchy’ cannot take hold in a DMS.
With a properly managed system of version control ensuring documents cannot be updated, changed or deleted accidentally - a company can keep their new product development processes running smoothly.
4. Companies are always ready for regulatory audits and inspections.
Regulatory and certification bodies around the world (such as ISO, the FDA and others) stress the importance of the regular review of quality documentation to achieve consistency in end products.
For those building apps and solutions in the highly regulated medical device market, FDA 21 CFR PART 820, specifies manufacturers must:
- Designate an individual responsible for reviewing and approving documents.
- Ensure the availability of the documents established to meet the requirements.
- Prevent the unintended use of obsolete documents
- Maintain records of changes to documents
- Reapprove whenever a document is changed
In ISO 13485:2016 there is a similar requirement to “review and update as necessary and re-approve documents,” although the frequency of update and review is left to the discretion of the company.
While ISO 9001:2015 does not talk about document review directly it does require that organisations “control the documented information” within their quality systems. This includes being able to show your ISO 9001 auditor that you have organised your quality management system documents with the most ‘updated information available’ and have a system in place to continue doing so.
Document review should be a critical part of every new product development process and the quality management systems that govern and control them.
But multiple individuals working within paper systems or with a combination of Excel and Google sheets are at a heightened risk of losing their way in complex, multi-department review processes.
On the other hand, those companies deploying a dedicated DMS (document management system) as a single source of truth with the right digital tools will find it easier to evolve and manage change, while doing so with maximum efficiency.
Finding a flexible and agile DMS that can set up sophisticated workflows to check and validate documents at critical times by exactly the right people should give you a competitive advantage you need. It should also give you the ability to meet the requirements of the toughest regulatory regimes and demonstrate to auditors you have a robust system in place that effectively controls the risk of product failure.