5. QSE Documents and Records Management

One of the essentials of Quality is for documents and records. High quality documentation is required for all of the other Quality System Essentials (QSEs) in any Quality Management System (QMS). Documentation provides the basis for standardization. The first thing you need to know is the difference between a document and a record. In simple terms, a document is a policy, a process or a procedure, as well as a form used to record set information. According to Roback (2011), “documentation provides a framework for understanding and communication throughout the organization. Documents describe how processes are intended to work, how they interact, where they must be controlled, what their requirements are, and how to implement them” (p.16).

Once a document has been filled in with information such as refrigerator temperatures, patient test results, employment history or some other type of detailed information, it then becomes a record. “Records provide evidence that the process was performed as intended and provide information needed to assess the quality of products and services” (Roback 2011, p.16). As you read through this module, the difference between the two terms will become increasingly clear.

According to CLSI (GP26-A4, p. 55) Policies that apply to Documents and Records include the following activities of the QMS.

Document Management System

• Creation, review, and approval of new documents
• Changes to documents
• Control of documents
• Use of external documents
• Storage and retention

Record Management System

• Creation and legibility
• Records review
• Changes to recorded information
• Storage and retention
• Destruction

Processes that go along with these policies include

• Description of the creation, approval and implementations of new documents and forms
• Description of the processes for making revisions and changes to documents and records
• Description of how to implement a document control system
• Description of how to store documents and records in such a way as to maintain integrity, prevent unauthorized access, prevent damage, deterioration or loss, and to facilitate retrieval
• Develop a schedule for retention of documents and records
• Develop a guidance mechanism for the destruction of documents and records
• Maintain a current library of laws, regulations, standards, guidelines and references.

Procedures that are needed for documents and records include

• How to create documents and forms using institutionally approved formats?
• How to obtain approval before implementing new documents?
• The procedure to follow when changing or replacing approved documents and records
• The procedures to follow for selecting storage media and location for documents and records, actually storing the documents and records and the labeling used on them
• The procedure for making changes to reports, records, and verified results
• The procedure to follow for destroying labeled materials
• Acquiring, cataloging, and updating reference materials

In a QMS, there are several standard documents that should always be included.

1. The organization’s Quality Policy
2. The Quality Manual
3. The QMS Documents

The Organization’s Quality policy is generally made up of several statements of claim

1. The customer service focus of the organization
2. the scope of service provided by the organization
3. a statement of the standard for service
4. the requirement for all employees to be familiar with the quality policies of the organization
5. a statement of commitment to good professional practice, the quality of service and commitment to the QMS
6. compliance to applicable legislation and regulation

The Quality Manual gives an overview of the QMS. It consists of an overall policy for each of the QSEs, identifies who in the organization is responsible for maintaining the Quality Manual, defines how the organization functions, and describes how it will meet all of the applicable requirements.

The QMS Documents consist of all the policies, processes, procedures, forms and records used by the organization. There are a variety of Documents and corresponding records used in every QSE of a laboratory QMS.

In the Quality Management System in a medical laboratory, there are policies for each discipline of the laboratory that provide an overview of the intentions of that discipline. These policies answer the question “What do we do?” in each area of the laboratory service and sets the standard for acceptable performance. Policies provide employees with a guideline to know what is considered to be an acceptable performance. All the policies of the laboratory are then compiled in the Quality Manual.

The processes in the medical laboratory lay out the way business is conducted. They have 3 distinct functions

• to describe the activities required to meet each policy
• to describe the correct sequencing of each process
• to identify the person or persons responsible for each part of the process

For example, in each laboratory area, there will be a process to explain how specimens are received, accessioned, processed, tested and reported. The process document will help to identify whose job it is to complete each part. Depending on the size of the laboratory, there may be several different processes depending on the method of specimen receipt, the designated area where the test is performed, or the time of day the specimen is received. The usual way processes are described in clinical laboratories is through flow charts or tables. Flowcharts are the most common method because they show a visual diagram of how the process flows and identify where the decision points for variation of process may occur.

Procedures are the detailed step-by-step path that must be followed in order to perform set tasks that occur in a process. In clinical laboratories, standard operating procedures or SOPs are used to lay out the exact steps to follow to correctly perform any test that the lab offers. There are also procedures that tell the employees how to respond to fire alarms, what to do in case of illness or other absence for the workplace, when and how to complete an occurrence report and many other things that occur in the course of the working day. Depending on the size of the laboratory, there may be a few hundred procedures or several thousand.

In order to keep all the policies, processes and procedures current, and to make sure workers are using the most current version of a policy, process, or procedure, the QMS requires that all documents of the organization are controlled documents. That means every document must be numbered and dated, identify who it is reviewed by and approved by, and identify the date of the next review as well as the date the document goes into effect. All previous versions of the document must be taken out of circulation.

A record is the final piece of documentation that is used regularly in clinical laboratories. Records are documents that have been used to track information. Some examples are patient reports that are used to record test results, documents that have been completed to monitor a refrigerator’s temperature over time or attendance check in sheets for a particular section of the lab. (Before a record is filled out, it is a form whose purpose is to be used to record information/data.) Depending on the purpose of the record, it may need to be saved for a long time. Items such as Maintenance logs and QC results may need to be stored for the life of an analyzer. Other records, such as copies of faxed reports, may be discarded after a few weeks or months. There are generally strict guidelines to follow to complete data for records and there are also very specific policies to determine how and where they are to be saved.

As we continue through this course looking at each of the Quality System Essentials, we will also discuss the variety of documents and records that are used to meet the requirements of standardization and quality practice throughout the laboratory.