How to improve your QA through innovative Knowledge Management

What exactly is Knowledge Management?

• The idea is to guarantee that people in the organisation understand exactly what they need to do and how to do it.
• Simultaneously, a structure should be in place to track who has what knowledge and who has finished what training. All the needed competencies can be tested and managed in a competency matrix.
• Knowledge management is also crucial in limiting the negative consequences of employee turnover. By maintaining and sharing vital knowledge, companies can continue operations, and learn from past experiences. 

The 3 main reasons why Knowledge Management is important in QA

1. Being in control of your company’s knowledge through Document Control prevents errors.

• Version control with major and minor changes ensures that all employees are working with the most up-to-date version of documents. This method is employed to avoid errors or outdated information. Controlled document leads to consistency and traceability.
• A standardised document identification system makes it easy to find the documents you need by code, title, description, process owner, language, site, or department, and so on.
• Before a document is considered final, it must go through a series of reviews and approvals by key parties. An automated workflow can help to streamline this procedure.
• Detailed audit trails record all actions performed on documents, including who accessed, altered, and approved them, as well as timestamps.
• The document history allows you to observe how a document was developed and preserve previous versions. As a result, all unused versions are taken down and cannot be utilised as the incorrect version but remain available as an archive.   

2. Sharing and enforcing knowledge through Training and Skill Management.

It is critical to understand the required skills and competences within an organisation. A competency matrix can help you determine who has what skills, who needs training, and who is qualified for a promotion or new position.

Competencies can be obtained through specialised document content or through internal training. Languages, skills, and other general competencies are acquired externally.

A skills matrix allows you to identify competency gaps and use them in a variety of contexts, including new employee onboarding, temporary replacements, and internal recruitment.

Watch our webinar 'Keep control of documents, skills and training' to learn more.

3. Adapting to change: update your knowledge and sync with the reality of your business.

Organisations are ever-changing. Employees must be informed when changes occur, and the knowledge management system must document and convey those changes. To do this, you work with distribution lists in which everyone to whom the document is relevant must appear. This is done based on responsibilities assigned to roles (not persons). That way, employees who change roles remain in the correct distribution lists.

When a new document or a new version of a document is created, the impacted employees are notified and must confirm acceptance of the document. Acceptance of the new document can take various forms: an email with notification may suffice, but in regulated areas such as pharma and GDP, confirmation that the document has been read and understood is required. To ensure that the document has been read and comprehended, a digital signature (e-signature) is needed, as required by 21 CFR Part 11.

The digital revolution

The digital age has altered the way we handle and share knowledge. Traditional, paper-based procedures are no longer adequate for modern organisations, particularly those in regulated industries. This is a hot topic during external ISO or FDA audits. Companies are frequently issued an FDA warning letter for failing to comply with this regulation.

Knowledge management is not an option for QA managers and quality assurance experts; it is a must. If you work in a regulated industry, having a solid system in place is much more crucial.

You can ensure that your organisation stays ahead of the curve and fulfils all quality standards and criteria by using the correct QMS software. The digital path is the only way forward!