Quality Management System Software

Take a walk around any Walgreens or CVS store and you’ll find hundreds, if not thousands, of cosmetics, medications, medicines, and pharmaceuticals available over the counter or from the pharmacy. If you watch television, listen to radio or browse the Internet, you are bombarded with advertisements for the latest cold remedy, hand lotion or shampoo to make you feel better, look better or cure some illness. These personal products and medications are intended to alter your look, mood or well-being, and therefore have the potential for good or harm.

In the pharmaceutical industries, quality refers to the identity, strength and purity of a product which relates to its safety and effectiveness. The public relies on the integrity and accuracy of pharmaceutical and cosmetics’ labeling and instructions to protect them from harm. Current Good Manufacturing Practices (CGMP) established quality standards within these industries to ensure products are safe and deliver the intended benefit or result. CAPAs, or Corrective and Preventive Actions, are processes used to investigate, identify and correct non-conformance as part of the CGMPs.

Regulations

The Food and Drug Administration regulates the manufacture, production and approval of these types of products. While it imposes strict guidelines, how a company regulates itself to adhere to the standards and its own internal processes leaves room for variation and error.

Industrial manufacturing and service industries can achieve ISO 9001:2008 quality system certification or some industry specific variation of the ISO 9001 standards in order to conform to globally accepted quality standards. In the United States, the FDA has established current Good Manufacturing Practices, or CGMPs, which outline quality system standards for food and drug manufacturers. CGMPs are not new or additional regulations for these industries. Rather, they establish standards for a quality system for these manufacturers similar to ISO 9001:2008.

The CGMPs are similar to ISO quality standards.

There are four major sections:

1. Management Responsibilities — As with ISO 9001:2008, management has overall responsibility for the establishment and support of the quality management system. They provide the resources, leadership and support within the organization for the establishment and maintenance of the system. They also are responsible for management review.
2. Resources – Management is responsible for providing the proper facilities and equipment to process and manufacture products according to specification and quality standards. The quality system also establishes guidelines to acquire and receive materials and for processing materials for use. It also provides for proper laboratory facilities and equipment to properly test and approve product samples and a system to document and affirm results. Qualified, trained personnel to perform all operations are another vital resource.
3. Manufacturing Operations – Quality systems rely on the proper design, development and documentation of manufacturing operations systems, procedures and work instructions. Once established, there must be a process for controlling documentation, updating for quality improvement and ensuring documents and electronic systems are secure and controlled.
4. Evaluation Activities – Corrective and Preventative Action (CAPA) is a well-established quality process that seeks to identify the root cause of deviations in quality process and product non-conformance to eliminate the cause and prevent further occurrence of the same or a similar situation. CAPA uses a closed-loop process to identify the source of a non-conformance and establish a plan of action for closure. Root cause analysis can involve customer complaints, end-users, vendors, workflow management, the training and experience of operators, reliability of documentation, quality of internal audits and the corrective and preventive action system itself.

Whether the CAPA system is electronic or manual, a reliable CAPA system is a vital component to CGMPs and ensuring the quality and integrity of manufacturing processes and products under FDA regulations.

To properly control quality, an organization must be effective at controlling its quality documentation.

Document control and management are vital to achieving and maintaining compliance in regulated environments. Forms and procedures must be accessible to those requiring them at any time, while critical records, including non-conformance reports, test analyses, and audit results, must be strictly controlled to prevent unauthorized access and modification or deletion. In many cases, document control is a full-time job for one or more employees within a business.

To help streamline the document control system, many companies have developed document control software that allows an organization to maintain and control access to its documents. Whether or not a small business should invest in document control software depends to a large extent on the complexity of the quality management system in place, the number and relative availability of employees to perform the task, and the end product of the business. Document management software is not needed in every organization, but for most, it can be a helpful addition, if not a direct contributor to the bottom line of the business.

Document control software can be as simple as a stand-alone repository for a business’s policies, procedures, records, and documents, or as complex as a fully integrated application with notifications through email systems.

It can route documents for review and approval, send reminders of corrective actions overdue, assign new corrective actions, notify employees when training is required, and notify quality managers when equipment calibrations are due. The system can be housed completely internally on one PC workstation, or stored externally on a client-based web application or in a cloud environment.

When a document control software solution is properly designed and implemented, it can provide a return on investment for a business. By carefully selecting and deploying components of such a system, administration of a document management system is drastically reduced, freeing employees formerly tasked with the responsibility to take on other responsibilities within the organization, thereby eliminating overhead. In some cases, it may be possible to reduce total organizational headcount.

Document searches can be completed quickly, saving time. Moreover, it improves the accuracy and reliability of the storage process, and can decentralize the system to allow users remote access to procedures and documents, improving the productivity of an organization.

Before any business, large or small, decides to invest in document control software, it should carefully assess its current document handling processes, and determine, in detail, exactly what it expects of a document control application, as well as its current electronic storage capabilities.

Small businesses will likely be successful with an existing off-the-shelf application and a single dedicated PC, while large companies may need to invest in customized software and a server, or contract for off-site data storage. It is critical for both simplicity and cost management to only purchase those portions of a system which are useful and add value to the organization. Investing in a large suite of document control modules that do not fit the needs of the business is wasteful, and overly complicates the software, training, and end use of the product.

Businesses investing in document control software should look for an application that is scalable with the business. Applications that can be integrated into an existing office suite are preferred for training and compatibility reasons, but are not necessary. Independent applications may afford the business with more capabilities, such as email reminders and automatic scheduling and approval routing. Regardless of the application chosen, it should have the ability to sign documents electronically, provide access control and password protection, and create an audit trail that can easily be followed for internal and third-party audits of the quality management system.

Small businesses will find that document control software applications exist in abundance that integrate easily with Microsoft Office and other business software suites. Some of the applications also exist as shareware or freeware, making their cost to the organization nil. In many cases, the same small business can use a stand-alone PC to house the application, and designate an individual within the organization to perform daily or weekly database back-ups to DVD for storage off-site or in a fireproof safe for records retention and business continuation purposes.

An independent PC with document control software also prevents hacking from outside intruders, and can be programmed for individual password access to specific documents and forms housed on the unit.

An investment in this type of hardware and software will be relatively small and affordable for the small business and will produce quick return on investment (ROI), yet will still enhance the quality management system requirements for document control and storage while at the same time allowing employees to be quickly trained to begin using the system.

So what really is cost of quality? Most complex issues need to be broken down to properly solve them. Cost of quality is no different. The total cost of quality is really made up of:

• The cost of good quality
• The cost of bad quality

To really gain a good understanding of how to move the cost of quality meter in the right direction, we have to focus on reducing the cost of good and bad quality. The good news is that there are tools to help us do this efficiently and effectively. One such tool is quality management software. Quality management software gives organizations a way to automate many of the process that comprise the cost of good quality, while improving the visibility into key performance indicators for the cost of bad quality (as you would expect in a very simple manner (:  )!

Whew, now we have an easy way to manage cost of quality and get us on the path to best-in-class. The really cool part about affecting cost of quality are the ensuing benefits: shorter lead times, reduced inventories, fewer late shipments, fewer returned materials, fewer compliance related issues, happier customers, and improvements in competitive advantage. For the details, check out the full Cost of Quality and Quality Management Software article.

We all know that Business Excellence does not come easy! But like most complex challenges, Business Excellence can be broken down to manageable chunks.In this article we define five key driver categories:

1. Metrics Management System
2. Quality Management System
3. Performance Improvement System
4. Customer Experience Improvement System
5. Management Improvement System

We discuss how each builds off each other. It is neat to see how the quality management system interplays with each category and ultimately is the glue that binds each category to each other! Oh yeah, one of the most important points of the article is that for each category we share practical best practices to help you implement as well as to know you are staying on the right track. Read on and let us know what you think! Quality Management System is The Glue that Binds Business Excellence.