As your company grows, the amount of documents your team creates and manages increase. This is great news as your company is growing! Never think that productivity must drop with increased documentation. It just mean that you need a process in place to manage them in a systematic and optimised manner. We call this ‘Document Control’. Without establishment of any document control, your business will inevitably be affected. This can lead to a lack of control over product, inefficiency, confusion and breakdown in communication.
That is why both ISO 13485 and U.S. FDA 21 CFR 820 require medical device companies to establish and maintain procedures to control documents as part of the company’s Quality Management System (QMS). Click here for the article that we have discussed previously on “What is a QMS?”.
Documents and records may sound alike, but there is a huge difference between them.
Documents are often created to describe certain processes, provide instructions or put a plan together to standardise workflow within a business. Some examples of documents are SOPs (standard operating procedure), forms and plans. Contents within the documents can be changed and must be updated accordingly with revision tracking.
Records are created as an evidence that a certain instruction or process has been carried out. Examples are experimental data, test results, equipment maintenance logs and etc.
Today, we have put together 8 key points to help you better control your documents and here’s how it should look like:
1. Identification of document – title, numbering
Document should be titled and numbered in a systematic way that allow easy identification. Naming and numbering helps everyone to search and identify documents easily, especially when there are tonnes of documents to crawl through over the years.
2. Reviewed and approved by appropriate key personnel
Before a document is officially implemented, it needs to be reviewed and approved by appropriate key personnel for accuracy and adequacy. The key personnel should be someone with good knowledge and clear understanding of the document content,
Approval details that need to be recorded include the dates and signatures of individuals. Take note that the approval date must precede the document’s effective date.
3. Version of document and effective date updated
Version and effective date needs to be updated and clearly indicated whenever there are changes to a document. This is to ensure that everyone is reading the correct version of the document.
4. Identification of changes made
A change record must be kept to include information such as description of the change, reasons for change and any other documents affected by the change.
5. Access of documents
Documents need to be stored in a way such that the appropriate employees can easily access them
6. Protecting document from unauthorised changes or loss
Designated controlled locations should be considered to store the master copies. Any documents outside these locations will be considered uncontrolled. If required, appropriate safeguard should be put in place to ensure protection and prevents unauthorised changes, access, damage or loss of documents. Managing user access comes into place here to ensure only certain employees can access the relevant document folders they are given the rights for.
7. Preventing the use obsolete documents
Obsolete documents should be withdrawn and segregated from the current documents to prevent unintentional use. Obsolete documents that are retained for reference or other purposes needs to be clearly identified through markings, separate storage or other means and with retention period stated.
8. Documents from external sources
Company should also ensure the confidentiality of documents from external sources. They can include customer, supplier or industry documents. These documents should also be identified and controlled with proper user access.
Document control is an essential preventive measure to ensure that only the approved and ‘current’ documents are used throughout the company. A good document control facilitates efficient operation and a functional QMS. Never overlook the importance of a proper document control which quite some companies may see it as a ‘not too important’ process to manage!
So start reviewing at your document control process or speak to us now for a complementary 30 minutes gap analysis!