QMS Pains in the Blood and Biologics World

For Blood & Biologics

Maintaining a quality system within a blood and biologics organization is a very resource-intensive endeavor. Changes resulting from new regulations, new and updated procedures, new techniques, changes in suppliers and supplies, new and enhanced safety practices, and the like, all result in a massive amount of change that must occur across the organization. Managing these changes in turn requires the assignment of multiple resources across multiple areas of an organization. These are just the quality process changes—There are also a multitude of documents within an organization that must be managed; everything from contracts to meeting minutes and press releases to correspondence with external regulatory agencies must be approved prior to distribution.

The quality of training separates good organizations from great ones.

After changes are made to various documents in the regulated blood and biologics environment, training must also take place. Making sure all affected employees are competent in regard to document changes is a process in and of itself. Staff must be trained and the organization's management must be assured that staff members completely understand the changes prior to performing the affected tasks. If this does not occur, then precious gifts in the form of donations can be collected or recovered incorrectly, wasting the gift and ultimately driving up costs.

These types of errors will obviously cause delays since error occurrences (i.e., deviations and nonconformance events) must be gathered and investigated to determine the cause and prevent its reoccurrence. Other types of occurrences must be also be compiled, such as customer complaints, supplier deviations, out-of-specification materials, and audit findings, to name a few. The collection of these events is driven by regulatory authorities and by the organization. Resources are wasted in rework and lost opportunities if these errors are not prevented.

Document Control

Document control is a very resource-intensive process. It begins when a change is needed to a document. There are many different mechanisms that drive document changes, some from internal and some from external changes. With literally hundreds of documents in multiple departments across multiple locations, the matrix of maintaining control over different document types can drive a quality department and operations to its knees. Factor in that there are likely to be numerous revisions to these documents throughout the course of a year and there is the setup for an improbable task to manage.The chance of mistakes occurring is huge when the document management system is a purely paper-based process. These mistakes can lead to serious regulatory issues for an organization, impacting community reputation and financial status. Throwing more resources at a paper-based document control system won't change the problem. It is still a manual process resulting in humans needing to find and replace documents. Getting these documents into the right manual in the right building in the right department and ensuring that the outdated version is collected and controlled is the single biggest resource drain on an organization. Employees who have to leave their work areas to hunt a document on task completion will find it more convenient to perform that task from memory. At that point, performance accuracy becomes anyone's guess as memories vary from employee to employee.In an effort to be more efficient, these employees may copy official documents and store them away. This allows for document revision but unofficial copies of outdated documents are probably still in circulation or stored away somewhere. It's possible that employees will pull these documents out during an audit interview, setting the organization up for a regulatory finding. The employees' intentions are not malicious; they want simply to speed up access to needed documents.Interestingly enough, an audit finding like this one just gives an organization one more thing to be tracked.


Almost every change within a regulated organization results in some level of training. Some of these changes are minor, requiring that staff only read and understand the modifications. Other changes result from the implementation of a new process or the major overhaul of an existing one and require more advanced training.Many regulated organizations are required to perform annual training for OSHA and GMP. Regardless of the reason, training is not something that can be taken lightly. The quality of training separates good organizations from great ones. Employees need to be trained on the changes and the "why's" of the changes. Employees who understand the "why's" of change are more likely to remember their training and buy into it, resulting in greater compliance. This in turn drives down mistakes that result in rework and loss of revenue.When training is paper-based, resources must be allocated to drive the paper collection process. New documents must be read by employees, who in turn document that they have read and understood the procedure. But what challenges the employee to prove their competency regarding the changes or new process?Organizations may employ techniques such as quizzes or classroom-style lectures to ensure mastery of the change. The challenge of administering these training tests can be exacerbated by employees working multiple shifts (common in the blood and biologics world) or at satellite offices and per-diem employees who do not regularly come into an office. All of these scenarios are too often the reality for blood and biologics organizations, requiring an even greater outlay of resources to ensure that employees are getting their signatures in a box on a training document.

Process Management

Managing processes is another resource-intensive activity endured by blood and tissue organizations. Most processes are managed by homegrown systems or on paper. These include quality processes such as corrective and preventive action, complaints, deviations, and audits, but there are a whole slew of processes that blood and biologics organizations must also manage such as calibration, equipment, preventive maintenance, and non-conforming product. Most of these processes are pushed out to the department level. This creates even more disparity in an already complex system as each department puts its own spin on these processes. In reality any processes that collect data need to be managed by an organization.In reality, any process requiring data collection needs organizational management. Paper-based systems cause disconnected islands of information, that are not connected creating redundancy within an organization. It is very difficult for an organization to avoid repaeting mistakes when data from similar processes are unable to be examined as a whole. A trend in data between these processes is very difficult to flush out. Even more difficult to determine is how these systems can be updated to fix problems when disparate systems are being examined.Locating all data-based processes in one centralized database allows data to be analyzed across the organization and evaluated for trends. These trends can be shared to develop a systematic corrective action, resulting in a stronger organization. Additionally, processes can be developed and deployed on a system-wide basis, decreasing organizational complexity and the need for resource allocation.


Hope for organizations working in paper-based environments lies in electronic quality management systems. These systems allow organizations to ease their regulatory burdens. Systems that combine document control, training and process management allow resources within an organization to be redeployed, tackling the problems that matter and need immediate repair.A centralized document control system operating electronically ends the need to stage multiple manuals to be staged throughout the organization. Allowing an employee to access documents right from his or her workstation (without the guessing games) greatly improves the likelihood that documents will be referenced quickly. This allows the organization to be in greater compliance, reducing the chance for error and the need for investigation.Electronic document control systems automatically move documents through a lifecycle. Employees don't need to physically remove and replace documents from manual to manual, from manual to document approver, etc. This ensures that employees are accessing the most current version of a document and that resources are being freed for value-added tasks. Most systems are configurable to meet individual organizations' unique situations and even allow for expiration dates and times to be stamped electronically on printed documents.When investing in an electronic quality management system, it only makes sense to select one with training capabilities. Imagine experiencing the relief of knowing that when a document is revised, training will automatically be launched to all affected users! Systems can even send an exam for a trainee to complete after reading the training information, establishing competency for employees.An electronic quality management system should incorporate an annual review feature so that documents can be tagged for review on an annual basis. It should also automatically resend training to those who are required to complete annual training.Select an electronic document control system with a process management feature which allows data collected by many diverse departments to be captured in a single location. This allows for trends across the organization, not just by department, to become visible. This has the increased benefit of being able to develop a single corrective action, instead of multiple corrective actions, to fix the same problem. Processes can be streamlined to meet the needs of the organization instead of the needs of a single department. All of this releases resources so other significant improvements can be made in other areas of the organization.

Rob Carpenter
is a Product Manager, Customer Relationship Manager and Blood and Biologics Expert at MasterControl, Inc. Mr. Carpenter has worked more than 16 years in the eye, tissue and blood banking industry, most recently as the Director of Tissue Processing for Community Blood Center/Community Tissue Services in Dayton, Ohio. During his tenure, he worked with various medical device companies to bring 13 new grafts to market.
As an active member of the American Association of Tissue Banks (AATB), Mr. Carpenter serves on both the Education and Program Committees and as a course director for the AATB's Certified Specialist Training and Review Course. He is a recognized speaker at blood and tissue conferences across the country. Mr. Carpenter holds a BS degree in Biological Sciences from the University of Cincinnati and a certificate in ProjectManagement from Xavier University.

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Additional Information"A National Biovigilance Network,"