The paperwork generated by a Quality Management System (QMS) can be overwhelming unless you implement a structure that is simple and user-friendly. The data can be retained in automated systems or in manual systems. Numbering automation is a common feature in software-based electronic document management systems such as the Grand Avenue Software. These types of systems have built-in tools that can automate document numbering which can make creating, managing, and tracking revisions/changes to documents easier and more efficient. Document numbers can be pre-set based on rules and criteria. Automation ensures that documents are consistent and that the numbering system is logical and easy to use.
Here are benefits that can be realized when storing manuals electronically:
>> Increases accessibility of quality documents
>> Multi-path delivery to employees facilitates use (email, database, website download, printed changes notification, procedure lookup, verification)
>> Electronic updates reduce costs by eliminating or reducing expenses associated with snail mail distribution of updates, change notifications, distribution of hard copies, and coordination of required signatures
>> Electronic updates of multiple manuals encourage continuous updates and continuous improvements in real time versus waiting for annual updates
>> Ease of regulation updates in the quality manuals allows for more time to inform, train, and resolve employee questions.
Document numbering’s purpose is to create a unique identifier for each document using a consistent and organized approach. For an organization to create a document control system it needs to identify the following:
>> The different types of documents used in the organization and how the numbering system can differentiate them.
>> The purpose of the document and who needs access to it.
>> A numbering format that works for the organization which could be alphanumeric or numerical along with the number of digits or characters.
>> A system that can grow with the company.
Unique identifiers should be meaningful so that users can easily locate a document by using that numbering system. This could include elements such as the document type and project names or department names. An example for a procedure document could be P = Procedure and if it’s a procedure for department 200 then the number could begin with P200. This makes it specific to that department. Develop a numbering system that is logical and consistent with the goal to improve the efficiency of the document control process and make it easier for users to locate and use documents.
Another example of a hierarchy of controls is as follows:
>> Level 1 Document = Quality Manual (the overall description of your QMS and a brief description of each element of your quality system).
>> Level 2 Documents = Standard Operating Procedures (detailing the general workflow in each area).
>> Level 3 Documents = Work Instructions (detailed, step-by-step directions for performing a specific task).
>> Level 4 Documents = Forms, Specifications (and other documents needed to further detail or support the manufacturing process).
The standards leave it open for an organization to develop its own system to meet the applicable requirements. The Food and Drug Administration (FDA) in 21 CFR 820.40 - Document Controls requires that any documents used in the manufacturing process be controlled.
Throughout ISO 13485:2016 references and requirements are made to maintain and retain records. Document Control covers the review and approval of new documents, the means to revise/change existing documents as needed and the removal of superseded documents from the system. Distribution of the document(s) to applicable end user(s), as well as collection and destruction of superseded controlled copies is also included.
Here are some of the sections in ISO 13485:2016 pertaining to document control:
4.1.6 states that “the organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and as appropriate, after changes to such software or its application.” It goes on to state “The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software.” This means that if the quality management system documentation is retained using software, then validation of that software is required based on the risk.
4.1.3 states that for each quality management system process, the organization shall establish and maintain records needed to demonstrate conformance to this International Standard and compliance with applicable regulatory requirements.
4.2.1 section titled “General” states that documentation “shall include a) documented statements of a quality policy and quality objectives; b) a quality manual; c) documented procedures and records that are required by this International Standard; d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation, and control of its processes; and e) other documentation specified by applicable regulatory requirements.”
4.2.4 section titled “Control of documents” states that “documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.5.” These controls include:
>> Review, approval, update, and re-approval of documents.
>> The current revision status of and changes to documents are identified along with the availability at point of use of relevant revisions to documents.
>> Documents remain legible and readily identifiable.
>> Documents of external origin that organization determines are necessary for the planning and operation of the quality management system must be identified and their distribution controlled.
>> Prevention of deterioration or loss of documents.
>> Prevention of unintended use of obsolete documents including identifying them.
>> Changes to documents must be reviewed and approved either by the original approving function or another designated function; and
>> Definition of the period for which at least one copy of obsolete documents shall be retained.
4.2.5 section titled “Control of records” states that:
>> Records shall be maintained to provide evidence of conformity to requirements.
>> Procedures are documented to define the controls needed for identification, storage, security and integrity, retrieval, retention time and disposition of records.
>> Methods for protecting confidential health information contained in records.
>> Records shall remain legible, readily identifiable and retrievable plus changes to a record shall remain identifiable.
>> Records shall be retained for at least the lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements, but not less than two years from the medical device release by the organization.
Even though there’s not a specific numbering system requirement published by FDA or ISO, an organization can realize benefits by having a document control system (DCS). These benefits can include helping to keep your business organized, improving comprehension by making it easier for employees to read and understand the information, and increasing efficiency for employees and auditors to retrieve this information.
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