How do you create and maintain a QMS document hierarchy?

Use EQMS products like Honeywell/Sparta DMS software which provides a functionality called Document hierarchy upto 5 levels . The operative procedure has major version , minor version , major-minor version while working on SOP , work instructions.

In my experience, the best way for everyone in the company to understand and follow quality documents is to have them be visually simple. No lengthy paragraphs filled with unnecessary jargon, no multi-page procedures. Simple and intuitive is the way to go, such as process flow charts and work instructions with clear step-by-step pictures. This saved a company I worked for during audit time because everyone understood what their process was and what was expected of them. The auditor loved it, too. We also used an easy-to-understand numbering system for document control. Basically: Document Type Code-Department Code-Document Number & Revision. So, an operating procedure for production would be "SOP-PROD-001 REV 01".

Please do not create a bureaucratic nightmare. Make sure you keep the documentation focussed on minimizing the risk of not meeting quality objectives and customer criteria. Overzealous document authors can easily get caught up in a writing exercise that digs into the esoteric. Keep the tone of the documentation crisp and to the point.

It starts at the top with the Quality Policy, which should not be long, wordy document. I’ve written ISO compliant QPs that were trifold brochures. I always made sure I had a good set of documented process maps showing core processes, then sub processes. I used these to create a whole document system - policy, high level procedures, work instructions and forms. Remember simpler is better when it comes to numbering systems.

A lot of these AI inspired articles feel dated. I haven’t heard much about a ‘hierarchy’ of documentation since the QS9000 days. Here is a strange concept, how about designing a management system that is focused on efficiency and effectiveness… even in our documentation. Focus on what works and is needed by the organization. Management systems vary widely in complexity depending on the needs of the organization. Like some organizational structures, even the structure of a management system can be flat.

Here’s where the visual of the “Quality Pyramid” shows QMS documentation level and hierarchy much more clearly—and succinctly—than a paragraph of narration!

A Manual can be a great road map for the QMS. Consider hyperlinking the documentation references in the manual directly to the procedure, work instruction. spreadsheet, database....Efficiency.

QMS pyramid level as follow *Quality Manual - This is what intend to achieve. It concerned Quality policy, objective, risk assessment, scope and stakeholder *Quality Procedure - it deal with who, when, why where - role and responsibilities, procedure and interaction with other SOP *Work instruction deal with stp-by-step method, checklist and guidance. * Record and form - This is objectives evidence. So, each document identify must find its way to this level to fit in to be existing for QMS document.

This is a myth. From the very early days of ISO 9001 (2 & 3) it was believed that a QMS was documented in this manner. Yes a quality manual and documented procedures were required, however the only reference to work instructions (as part of 4.9, Process Control) was purely optional and indeed couched in the following terms "documented work instructions, where the absence of such would adversely affect quality"... It also doesn't consider other types of documents which cannot be pigeon-holed in this manner. It's a solution looking for a problem. People who cling to this outmoded and inaccurate model of documentation are likely to create a monster which must then be fed.

If English is not the primary language spoken at the organization, other language translations may be appropriate. I've run into this with regard to signage, emergency procedures...In my experience, Quality has been behind in keeping up with diverse language communication.

Any quality system should be based upon the maturity model within the organization and its ability to stay controlled within the QMS. The challenge for many of us gray hairs is finding the best personnel to maintain the intent of the QMS and allow for greater maturity within the system and organization. I agree that we dont need lengthy, complicated procedures, but rather an excellent identifier system for risk assessment and hazard identification. Because it appears most contributors are with the ISO space and not the FDA regulated space, understanding the move toward a mature model, may be difficult, especially when we have a requirement for a procedure exists after each statement in the CFR.

Clearly define who has editorial rights. Communicate this and offer an input process for all employees impacted by the procedure. Communicate changes. Test the change to ensure you aren't creating a problem that didn't exist before.

I am fond of utilizing periodic document reviews; however, most places have moved away from that practice. I think it is very helpful for keeping the documents up to date and in proper order for each area of use for those areas to 'know' what documents exist for each area and for new people to be trained to follow them.

It's important to establish who is responsible for each document and to keep that up to date with the current organisation. Where you can try and get Process Owners to generate their own content in a format they like and put QA in an enabling role rather than having them write documents themselves.

Define the periodic review of documentation to ensure the language is still current. Offer the opportunity for those doing the work to participate in the review input. They have more answers for the day to day operations than you can imagine....They are the subject matter experts.

It is crucial to periodically review and update the information, while also ensuring that any unnecessary documents or information are removed or made obsolete.

The fourth crucial step involves effectively controlling and updating documents within your Quality Management System (QMS) to ensure they remain current, accessible, and secure. Utilizing a document control system, whether it's a software application or a cloud-based platform, is essential for managing and tracking QMS documents efficiently. Here’s how to establish and maintain this process: 1.Document Control System Implementation (Selection of System and Implementation) 2.Document Control Procedure Establishment (Roles and Responsibilities, Document Lifecycle Management) 3.Audits and Reviews(Audit Schedule, Criteria & Continuous Improvement) 4.Security and Access Control (Access Permissions & Data Security)

DMS is a very good software to control & update all documents of any management system, if one is not going for traditional hard (paper) copies. Gopendra Eurocert Inspection Services Pvt Ltd. Panchkula -140603 (India)