Records and Documents in QMS | How can records and documents linking increase the level of quality?

Article Context:

1. Quality Records and Documents
2. ISO 9001 Quality Management Principles
3. What is record linking, document linking, and record-document linking?
4. Importance of Record Document Linking
5. Record Document Linking Feature in QMS

Quality Records and Documents

Quality Records and Documents  – Non-Conformances (NC), Corrective Actions and Preventive Actions (CAPA), Change Requests (CR), Bill of material (BOM), Complaints, SOPs, Work Instructions, Manufacturing processes established by the FDA and ISO to prove the quality processes, procedures, and practices of the quality management system in a life science industry. So the organization shall establish a process to document the identification, investigation, root cause analysis, approvals, storage, retention, retrieval, and disposition of records/documents. Based on ISO 9001, the process approach is critical. Hence the records and documents remain legible, readily accessible when required for audits, and retrievable.

To comply with the regulatory standards, the quality records are the ready evidence of the organization’s quality process executions. The record is the standard process that is structured, defined, and established to develop a quality product assuring customer satisfaction.

Although the documents and records have the same intent, they differ in meanings in the information field. Documents are written electronic matter providing information on the practices, processes, and procedures which can be updated and revised legibly as and when required. Records are issues/occurrences in the past that are investigated and documented, which cannot be edited or altered.

ISO 9001 Quality Management Principles

ISO 9001 Quality Management Principles – Process linkages like record to record, document to document, and record to document linking is the most important in managing and improving the quality processes. A Quality Management System (QMS) aims to achieve quality and ensure customer satisfaction. To sustain quality performance, process linkages like the record-document linking are critical. However, many ignore its importance.

This blog will help understand the importance of process linkages for meeting the quality requirements while adhering to compliance and regulations.

What is record linking, document linking, and record-document linking?

In simple terms, record-record linking, document-document linking, and record-document linking are nothing but process linking. Therefore, records and documents are considered a process. A process is a set of tracked and managed activities to achieve transformation. For example: When an issue is raised as a request in Quality Management System (QMS), be it NC or CAPA, it has to undergo a set of activities like the investigation, root cause analysis, verification, effectiveness check, corrective, preventive actions, and the information supporting these activities are documented. The procedures followed in line with the process transformation need interaction with one another. So, when we take an input, be it an issue, or a procedure revision, performing activities like incrementing the version of a document making it practical for use, performing an effectiveness check, or corrective or preventive action, we are engaged in a process. For example, a customer complaint about the product or service he wants when raised as an issue involving a change in a set of requirements can be evidenced when the record interacts with the documented procedures. To achieve this, record–document linking in QMS helps.

Life science industries get the importance of NC, CAPA, CR, BOM, etc., to manage and improve the quality processes; however, they fail to notice the process linkages – Record-Document linking. ISO 9001 – Documents and Records requirement – a process or a set of activities to identify, determine, manage, and produce desired outcomes is possible with the identification and interaction of processes as the output of a documented procedure may constitute the input of an issue request.

Importance of Record-Document linking

The primary purpose of ISO 9001– Mandate Record-Document is to comply when questions are raised on faulty products or services. In addition, records and docs are needed to prove the procedures, work instructions, corrective and preventive actions, and their effectiveness. The secondary purpose is to make the data (records and documents) accessible and available to improve the quality process, ensuring the relevant data retrieval at any time to analyze and help improve the processes adhering to compliance and regulations. So, implementing a QMS is to have a centralized system for continuously driving improvements.

Record Document Linking Feature in QMS

Record – Document linking is a feature in QMS to help identify the pairs of relevant information representing the same entity of varied sources. There are many reasons why linking data stemming from different sources is beneficial. First, the data relevance from other sources increases the chances of effective root cause determination. In addition, it increases the risk mitigation possibilities as relevant issues and documents are required to establish interactions and possible causes and effects. Furthermore, it increases the efficiency of determining actions.

To improve the overall quality processes, it is essential to ensure that the overall process is not impacted. Therefore, by better understanding the process linkages, the organization can improve the overall efficiency of the quality process. In addition, the whole process can be enhanced, saving time and resources by knowing how the processes interact with each other.