The “M” in QMS is a double-edged sword. The Quality Management System needs to control and manage the GMP systems, operations, and processes that keep an organization functioning at a high standard of quality and compliance. The QMS is also something that needs to be managed effectively so it can achieve that high standard of quality and compliance.
Does any of this sound familiar? Our IT Quality & Compliance Solutions experts share detailed perspective on maintaining today's QMS...
Preface• SOPs have become a repository to manage audit observations and responses, both a method of demonstrating control of a process found to be insufficient and reminding --end-users of the “what” and “why” certain process steps are required.
• GEMBA walks and internal audits have morphed into a catch-all for documentation errors, training lapses, or calibration or maintenance issues rather than focusing on the larger process issues that keep an organization running smoothly and efficiently.• Standalone CAPAs are meant to capture improvements and changes. However, if there are hundreds of CAPAs and a significant number of them are long-term projects with an overall goal of observing and gathering data, it’s a sign the QMS is not being managed effectively.
Retention & Recall: Training is Paramount
Training is always a key element of an effective QMS. It’s important to create training tools that encourage retention and recall rather than relying on the standard “read and understand” method so prevalent across industries.
To support value-added training and keep the “M” in the QMS, strong documents are an essential part of an effective QMS. Too often, however, documents end up being a confused mix of requirements, policies, instruction, explanation, and record-keeping. Another problem facing organizations is scope creep and identifying the right personnel to train on new and revised documents, which supports the purpose of value-added training.
Streamline Your Documentation
Streamlining the documentation system can achieve a variety of benefits. Narrowing the focus of any given document can mean higher retention rates in learning. End users also don’t have to rely on a multitude of resources for the same information; it should all be contained in a logical manner for easy reference.
To achieve that, documents should have a clear hierarchy within an organization. It’s sometimes difficult for internal personnel to achieve this result because they see the inter-connectivity of the processes first and foremost. This is where a third-party like Process Stream, experienced consultants with 25+ years in GMP documentation and QMS, can be most effective in streamlining documentation.
Designing the documents through a systematic approach that is resistant to its interconnectivity allows for a logical flow of information without the overlap that is too often found in QMS documentation systems. This also prevents “scope creep” which is discussed later.
• Top tier documents are the “why” and describe the regulatory requirements and the policies an organization will adhere to in achieving their goals. These documents should lead decision making when senior management is designing the system to manage their departments.
• Middle tier documents will describe the programs used to roll out these requirements. This middle layer is the “what” document – what programs are in place to execute the policies and requirements described in the top tier documents. Both the top and middle tier documents are meant to be a high-level umbrella documents that apply to multiple parts of an organization. This leads to the development of the execution documents which come next and are specific to a site, department, process, etc.
• Bottom tier documents capture the “how” and describe in sufficient detail the steps to perform a task or execute a program. The bottom tier of documents may be split into multiple layers, depending on the complexity of the task.
For instance, a document may describe the performance of in-process testing on samples pulled during filling and include all the sample testing to be performed, the frequency, the storage conditions, documentation of results, and notification to management. A job aid may then describe the detailed steps to perform one of the sample tests. Other quality managed documents in this bottom layer may include record keeping (forms), controlled lists, quality agreements, protocols, logbooks, and reports.
Separate to the quality managed documents, an organization may see the need for guidance documents to provide insight or tools to perform different tasks. These are usually non-regulated documents and as such, should never include requirements. Simplifying documentation reduces the downtime needed for training but also raises the efficiency of the actual time spent training. A more efficient workforce means reduction in costs, a reduction in deviations and CAPAs, and an increase in quality and compliance.
The Importance of Third-Party Review
Scope creep, as mentioned earlier, is another problem plaguing organization documentation and one of the primary benefits of hiring a third-party reviewer. It’s tempting when writing a procedure to bring in other elements of the QMS as a way to explain a process step or program design. This is dangerous, however, because if the information captured is part of another program requirement and that program changes, then a conflict is created between the two documents. Conflicts equate to deviations.
A third-party reviewer is more likely to identify the cross-over between documents and keep the document’s scope focused. Process Stream’s document simplification and streamlining increases efficiency by simplifying documents without losing the important aspects needed to manage the process or system.
A secondary issue related to scope creep is found in the roles and responsibility (R&R) section. Here’s a sample of the R&R in a calibration document:
- • All personnel are responsible to ensure equipment is routinely calibrated
- • The Calibration Technician will perform the duties as assigned in this procedure
- • Department X is responsible for training personnel on this document
- • Department Y is responsible for updating this document
- • Department Z is responsible for performing maintenance on instruments found out of calibration
This R&R basically requires that all personnel in the company – from the CEO to housekeeping – train on the document. It’s vital to identify the appropriate level of responsibility in a document. This has the downstream effect of reducing the number of documents included in an employee’s training plan and allowing them to focus their attention on task-specific training.
Having an intimate knowledge of the inner workings of a QMS is vital to keeping an organization focused on quality and compliance. It can be detrimental to focused and streamlined documentation, however. Broadly written documents also have a negative impact on efficiency if users are confused to how the information is to be applied in their jobs. Finding the balance to the mentality of “if it’s not written down it didn’t happen” will keep quality objectives and goals at the forefront of attention and make training a smoother and more efficient part of the QMS.
The consultants at Process Stream are experienced in GMP quality systems and documentation and can assist with benchmarking an organization’s documents against best industry practice. Process Stream offers flexible resources in the changing landscape of today’s business world.
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