Laboratory Quality Management System PDF

12-6: Personnel records Policy Medical laboratories should maintain employee records that contain information integral to their laboratory-related work. Keep records of positions held and dates for each of these positions. This information is important for calculating...

12-6: Personnel records Policy Medical laboratories should maintain employee records that contain information integral to their laboratory-related work. Keep records of positions held and dates for each of these positions. This information is important for calculating employee benefits. All terms and conditions of employment should be a part of the personnel record. What Personnel information that the laboratory maintains may differ in different regions and settings. While a complete list of information may include the following, some parts may not be required in all regions and all settings:  employment details;  original application and resume;  tests the employee is authorized to perform;  conditions of continued employment;  job description;  both original and subsequent competency assessments;  continuing education programmes attended;  personnel actions—corrective, disciplinary;  leave records;  health information, including records of work injury or exposure to occupational hazards, vaccine status, skin tests (if any);  performance appraisals;  emergency contact information. Where The personnel files should be kept in a secure site to protect confidentiality. Not all information needs to be maintained within the laboratory offices. Some institutions maintain a human resources or personnel department that may be responsible for employee records. Consider what is essential to be maintained in the laboratory itself, such as emergency contact information or job descriptions. Laboratory Quality Management System 147  12-7: Summary Important Management of personnel is critical to the success of a quality management principles of programme. Several elements are important in this management process. Job personnel descriptions should reflect all skills needed and accurately describe tasks, roles, management and authorities. The competency of personnel will need to be evaluated at the time of hiring and on a regular, recurring basis. A very important part of the management process is to seek ways to attract qualified personnel, and to provide motivation and appropriate benefits and working conditions so as to retain staff. Key messages  Personnel are the most important resource in the laboratory.  Managers must create an environment that will fully support all laboratory personnel in order to maintain a high quality of laboratory performance.  Continuing education is vital to personnel competency, but does not need to be expensive. New testing methodologies and instruments are constantly introduced to the marketplace, and employees need to update their knowledge and skills. 148 Laboratory Quality Management System 13. Customer service  13-1: Overview Role in This chapter will describe basic quality elements that are essential for Organization Personnel Equipment management developing an effective customer system service programme. Customer satisfaction is a Purchasing and Process Information major component of a quality inventory control management management system, and a significant focus in the International Organization for Standardization (ISO) standards. Documents Occurrence and Assessment Ultimately, the laboratory produces records management a product—the test result—for its customers. If the customer is not well served, the laboratory is not Process Customer Facilities and achieving its primary function. improvement service safety Overview Philip Crosby defined quality practice as meeting the requirements of the of the customer. He applied this practice to business and manufacturing, but it is process equally important for a medical laboratory. The medical laboratory needs to know who its clients are, and understand clients’ needs and requirements. Medical laboratories have a range of customers including patients, physicians, public health agencies and the community. Laboratory It is the responsibility of the laboratory director to ensure that the customers’ responsibilities needs are met, and that there is customer satisfaction. The quality manager is responsible for measuring the degree of customer satisfaction, using surveys, indicators and audits to take preventive and corrective action. All laboratory staff must understand the importance of customer satisfaction. Laboratory personnel must always interact with customers in a way that is appropriate, providing needed information, and being courteous. 150 Laboratory Quality Management System  13-1: Overview Establishing a Seeking customer satisfaction requires the following: programme to 1. Commitment—customer satisfaction is a requirement of several international address customer standards for laboratory quality, but some laboratory staff might consider it satisfaction secondary to technical competency. Because of the importance of customer satisfaction in a quality system, all staff must be strongly committed to the process. 2. Planning—monitoring takes time and planning to be done properly.Appropriate monitoring tools need to be developed prior to gathering information. Poor planning results in inadequate information and often leads to uninterpretable information. 3. Knowledge—creation of useful monitoring tools requires specific knowledge. If there are not people in the laboratory that have that knowledge, the laboratory may consider sending staff for special training or hiring a consultant. 4. Resources—the process to monitoring does not have to be heavily resourced, but it does take time. Some of that time can be saved by having access to calculators, computers and the internet. Laboratory Quality Management System 151  13-2: The laboratory clients—the customers The laboratory The laboratory has many clients and the needs of all must be carefully addressed. and its clients A central figure in the client list is the physician or health care provider. The initial request for service originates with this person, and the laboratory staff generally identifies the ordering physician as the primary client. Remember that in a hospital setting, the health care provider will be assisted by many other people, including nurses, medical assistants, phlebotomists, and secretaries or clerks. These vital hospital personnel should also be considered clients of the laboratory, and their needs must be considered. Another important client for the laboratory is the patient, usually including their family. Family members may play a very important role in patient management, and may help with sample collection and transport. When laboratory testing is being performed to meet a public health need, public health officials or workers become clients of the laboratory.The laboratory is a critical partner in surveillance, disease detection and prevention, and other public health programmes. Laboratories need to meet the needs of the public health workers in addressing problems. They sometimes need to share information without compromising the confidentiality of the patient. Specialized laboratories such as food safety or water testing laboratories would have other customers to consider, such as food producers, manufacturers, or water systems managers. The community in which a laboratory works also has expectations. The community needs to be assured that the laboratory will not create a risk for workers, visitors or the public. In many countries, laboratory tests can only be ordered by a licensed health care provider—a physician, nurse or dentist. In some countries, laboratory tests can be ordered by the patient directly without referral from a physician or nurse. Some patients do not have the knowledge or expertise to order the right test or to interpret results. Laboratory personnel may have to provide assistance in test selection and interpretation. Legal International standards usually require that any laboratory clearly identifies itself identity to the public, giving assurance that an identified person is in charge and accessible. At a minimum, every laboratory must make public a laboratory name and address, and the name of the director, including relevant contact information. 152 Laboratory Quality Management System  13-2: The laboratory clients—the customers Physician or The health care provider expects to have access to accurate, clinically relevant health care information that can be understood and used in a timely manner. Health care provider professionals need assurance of laboratory responsibility throughout the testing requirements process, including pre-examination steps, the testing process itself and the post- examination process. In the re-examination phase, physicians will be particularly interested in the test menu. They benefit from an accurate collection manual, requisition forms that are complete but user friendly, and a timely delivery system. For the testing or examination phase, physicians would like to be sure of working with competent personnel. They need to know that the test methods being used have been validated, and that testing is done with good process control and with quality control procedures in place. Appropriate management of all adverse occurrences or errors will significantly affect physician laboratory use. Patient The physician looks to the laboratory to do an excellent job in managing the requirements post-examination steps, as these are critical to receiving the results of testing. A solid laboratory information system, a method for results verification, and for delivering timely and interpretable results to the right place, are all important. The patient expects to receive personal care, keeping in mind comfort and privacy. He or she also expects to be assured that the testing has been done correctly and properly, and provided to the health care provider in a timely manner. The laboratory actions needed to meet the patient requirements include:  providing adequate information, both for collection of a specimen, and also information about the laboratory;  providing good collection facilities;  having available trained and knowledgeable personnel—personnel should know how to collect a sample properly, and should be trained to be courteous to all patients;  giving assurance that the laboratory records are maintained properly so that they can be easily retrieved, and also giving assurance of protection of the confidentiality of the records. Public health Public health professionals have the same needs as health care providers, requiring requirements that all parts of the pre-examination, examination and post-examination processes are carried out properly. They may need special kinds of information in dealing with an outbreak or epidemic, such as specific collection processes or forms designed for the particular project or investigation. Public health officials will also be particularly concerned with safety issues and containment of infectious material. Food manufacturers and producers, and water plant managers will need information from the laboratory to help them comply with their specific quality requirements. Laboratory Quality Management System 153  13-2: The laboratory clients—the customers Community The community in which a laboratory does its work expects that dangerous requirements materials will be kept within the confines of the facility, and that the laboratory will protect their own workers from risk. The community should be aware of communicable disease alerts, and surveillance and response activities. The laboratory is responsible for assuring safety and security, for containment of any infectious materials, for dealing appropriately with waste management, and for following all regulations for the transport of dangerous goods. Serving all All clients benefit when a laboratory chooses to put in place a quality system and clients well to seek recognition that it is accredited to the highest standards. This provides assurance that the laboratory is following quality practices, and that the results it produces are accurate and reliable. Good customer service provides:  valuable information for best patient care  valuable information to improve surveillance and other public health actions  a professional image for the laboratory. Customer service is an integral part of a quality management system. 154 Laboratory Quality Management System  13-3: Assessing and monitoring customer satisfaction Methods for In order to understand whether client needs are being met, the laboratory will assessment need to employ tools for gaining information. The laboratory needs to actively seek information from customers, rather than just waiting for customers to contact the laboratory with a complaint. Important information on customer satisfaction may be obtained using:  complaint monitoring  quality indicators  internal audit  management review  satisfaction surveys  interviews and focus groups. The monitoring of customer service and customer satisfaction is part of the continual improvement performed by the laboratory. Using When the laboratory is contacted about a problem, this can provide important assessment and helpful information. All such complaints should be thoroughly investigated, methods and remedial and corrective action taken. However, remember that received complaints may reflect only the “tip of the iceberg”, because many people do not complain. The laboratory cannot use received complaints as the only means of assessing customer satisfaction. Quality indicators are an objective measure of laboratory practices.Indicators can be developed that look at complaints, timeliness, patient refusals, and lost or delayed laboratory reports as examples. When these indicators are being monitored, information about customer needs and satisfaction will be acquired. When the laboratory conducts internal audits, some aspects of laboratory practice that affect patient satisfaction can be examined. Examples might include turnaround times—always of great concern to physicians or health care providers. All findings from these investigations should be very carefully reviewed by management and followed up with appropriate action. Laboratory Quality Management System 155  13-4: Customer satisfaction surveys Customer In order to actively seek information about how clients view the laboratory’s surveys service, it will be necessary to conduct surveys (paper-based or electronic) or to use interviews and focus groups. In this way the laboratory can address specific questions to areas of concern, and can look at areas not commonly covered by complaints or internal processes. ISO standards put a heavy emphasis on the importance of customer satisfaction; customer surveys are required in ISO 9001 standards for quality management systems. Any laboratory that implements a quality management system, whether accredited or not, needs to use some method for surveying clients in order to understand whether needs are being met. To be successful, surveys should be carefully planned and organized.Deciding which clients to ask to participate in a survey is important. Surveying health care practitioners is often easier than surveying patients. Laboratory staff can also be asked to participate in surveys and may offer good suggestions for streamlining operations to improve customer service. Any survey questionnaire should be pretested for clarity. When developing material, avoid leading and biased questions. Be sure to analyze the results in a timely manner and, when possible, provide some feedback to the group that has been surveyed. If the survey is to be conducted using interviews, the following tips can be helpful.  Write out all questions in advance, so that everyone is asked the same questions.  After asking some specific questions about their satisfaction with the laboratory, ask an open-ended question that allows customers to provide honest feedback. For example, ask how the laboratory could improve its service. Employing focus groups can be a very useful technique for gathering information on customer satisfaction. The process of a group discussion will often elicit comments and ideas from all the participants that might not otherwise surface. When conducting focus group discussions, consider the following:  assemble small groups of 8–10 people  include people with diverse backgrounds and laboratory needs  start by asking questions that build trust  develop a focus group guide for consistency between groups  ask open-ended questions—not “yes or no” questions. Summarize verbal responses in a written report that can be used by the laboratory as a tool to improve customer service. 156 Laboratory Quality Management System  13-4: Customer satisfaction surveys Successful When measuring customer satisfaction, whether by survey, indicators or audits, surveys identify much will be learned when the method is successful. This information and the opportunities for insights on customer service that it provides can be used to help the laboratory improvement identify opportunities for improvement (OFI).The OFI will lead to preventive and corrective actions. Information gathering must lead to change in a continual improvement process. Laboratory Quality Management System 157  13-5: Summary Summary Seeking customer satisfaction requires commitment from the laboratory management and staff. It is important to remember that technical competency is not the only goal for the laboratory. A programme for addressing customer satisfaction requires good planning, the development of appropriate monitoring tools, and the knowledge to apply the tools to gain usable information. Customers or clients of the laboratory include physicians and other health care providers, hospital and clinic staff, patients and their families, public health officials and the general community. Monitoring customer satisfaction requires some resources, primarily involving staff time. Managers need to ensure that these resources are available. Key messages  Meeting customer needs is a primary goal of the laboratory.  Everyone in the laboratory is responsible for quality and, therefore, for customer service.  An active quality management system ensures laboratories meet all client requirements. 158 Laboratory Quality Management System 14. Occurrence management  14-1: Overview Role in quality Occurrence management, or dealing management with laboratory errors, is important Organization Personnel Equipment systems in ensuring good service from the laboratory. It is one of the 12 quality essentials and must be addressed in laboratory quality management. Purchasing Process Information and control management inventory This chapter will describe and explain basic elements that are essential for developing an effective Documents Occurrence and Assessment occurrence management programme. records management Facilities Process Customer and improvement service safety Overview Occurrence management is a central part of continual improvement. It is the of the process by which errors or near errors (also called near misses) are identified process and handled.The goal of an occurrence management programme is to correct the errors in either testing or communication that result from an event, and to change the process so that the error is unlikely to happen again. Well-managed laboratories will also review their systems and detect process problems that could possibly cause error at some time in the future, allowing for prevention of these errors. Definition An occurrence is any event that has a negative impact on an organization, including its personnel, the product of the organization, equipment, or the environment in which it operates.All such events must be addressed in an occurrence management programme. 160 Laboratory Quality Management System  14-2: Sources and consequences of laboratory error Causes of Some of the common causes of error in the laboratory are easily identifiable, and laboratory error are also readily correctable. For example, some errors may occur because staff are unclear about who is responsible for carrying out a particular task, so it may remain undone.To prevent these types of errors, individual responsibilities must be clearly defined and communicated. Other errors occur when procedures are not written or followed, and staff are not adequately trained. Written procedures serve as a guide for all staff, and help to ensure that everyone knows what to do. It is essential to ensure that these written procedures are followed correctly. Staff need to be trained in how to conduct the procedures and, if this training is neglected, errors can result. There are many other sources of error in addition to these, which are frequently observed. While they often occur during pre-examination and post-examination processes, errors can occur throughout the testing process. Useful studies for understanding sources of laboratory errors include a retrospective data collection that found Australian pathology laboratories had a transcription error rate of up to 39%, and an error rate of up to 26% for analytical results.1 A report from the College of American Pathologists in collaboration with the Centres for Disease Control and Prevention Outcomes Working Group describes error stratification in the working process for clinical laboratories. In more than 88 000 defects, 41% were observed in the pre-examination phase of testing, 55% in the post-examination phase and only 4% in the examination phase.2 Pre-examination Some examples of pre-examination errors that are frequently seen include: errors  collecting the wrong sample;  mislabelling or failing to label the sample;  storing the sample incorrectly prior to testing, so that the sample deteriorates;  transporting the sample under conditions that damage the sample or that endanger staff and public safety;  damaging the reagents or test kits by storing them improperly. 1 Khoury M et al. Error rates in Australian chemical pathology laboratories. Medical Journal of Australia, 1996, 165:128–130 (http://www. mja.com.au/public/issues/aug5/khoury/khoury.html). 2 Bonini P et al. Errors in laboratory medicine. Clinical Chemistry, 2002, 48:691–698 (http://www.clinchem.org/cgi/content/full/48/5/691). Laboratory Quality Management System 161  14-2: Sources and consequences of laboratory error Examination A list of common errors that occur during the testing process include: errors  failing to follow an established algorithm (e.g. for HIV testing);  reporting of results when the quality control material tests out of range;  incorrect measuring of the sample or reagents (usually these are dilution or pipetting errors);  using reagents that have been improperly stored, or after their expiration date. Post-examination Many of the common laboratory errors occur following the testing of the sample, errors and some of these may be more difficult to detect. Common examples of these kinds of errors include:  making a transcription error when preparing the report;  producing a report that is illegible, usually caused by poor handwriting, but sometimes by damage to the report form;  sending the report to the wrong location, which often results in complete loss of the report;  failing to send the report. Consequences of The laboratory is a critical partner in all health systems, and it must perform its laboratory error functions well in order to help ensure good outcomes of health programmes and interventions. A failure in the laboratory role can have s significant effect, producing:  inadequate or inappropriate patient care  inappropriate public health action  undetected communicable disease outbreaks  wasting of resources  death of an individual. 162 Laboratory Quality Management System  14-3: Investigation of occurrences Occurrence A cycle of events reflects the process of occurrence management. When cycle includes occurrences are found, they must all be investigated to find the causes of the investigation problem. The investigation will help to identify the actions needed to correct the problem and to ensure that it does not occur again. All necessary communication must take place, including informing any health care providers whose clients are affected. Detecting Occurrences are detected through a variety of investigative techniques. occurrences Monitoring of complaints and satisfaction surveys will yield much information. Once the laboratory establishes and monitors quality indicators, deficits will be noted. The tools of external assessment, such as proficiency testing, external quality assessment, accreditation and certification processes, will be very useful in occurrence management. A very valuable tool is the internal audit, which can be performed at any time in the laboratory. The laboratory’s process improvement efforts will identify opportunities for improvement. It is the responsibility of management to review all the information that results from use of these tools, and to look for underlying patterns and potential causes for persistent or repeated error. Investigation involves gathering complete and detailed information about events that led to a problem, and a thorough analysis to determine all the factors that contributed to the problem occurrence. Root cause The most aggressive and complete approach to addressing occurrences is to seek analysis the root cause of the problem.This is more than just a thorough examination, but is a planned and organized approach toward finding not only the superficial causes of a problem, but also the deeper or core problems.With some occurrences, they are likely to reccur until such time as the true root causes are discovered and addressed. Wrong Cross- blood match Samples not group sample labelled at bedside given mislabelled Two patients  Major collected  transfusion Samples  reaction taken to Switched nursing samples station Laboratory Quality Management System 163  14-4: Rectifying and managing occurrences Correction of As a reminder, an occurrence is any event that has a negative impact on an occurrences organization, which includes personnel, product, equipment or the environment. There are several levels of action that may be undertaken to rectify occurrences, including the following.  Preventive actions involve a planned and organized evaluation of processes and procedures to identify potential error points, so action can be taken to prevent the errors from ever occurring. Preventive actions require planning and team participation.  Remedial action, or remediation, is the fixing of any consequences that result from an error. For example, if an erroneous result has been reported, it is essential to immediately notify all persons concerned about this error and to provide the correct result.  Corrective actions address the cause of the error. If a test was done incorrectly, resulting in an incorrect result, corrective actions sort out why the test was not performed properly and steps are taken so that the error does not happen again. As an example, a piece of equipment may have been malfunctioning, and the corrective actions would be to recalibrate, repair or otherwise address the equipment problem. Occurrence The laboratory should develop a system for prompt investigation of every management laboratory problem and error. The management process for dealing with errors process or occurrences involves several steps. 1. Establish a process to detect all problems, using the tools that are available. Remember that problems may go undetected unless there is an active system for looking for them. 2. Keep a log of all problem events that records the error, any investigation activities and any actions taken. 3. Investigate the cause of any problem that is detected and carefully analyze the information that is available. 4. Take the necessary action (remedial and corrective)—if the problem is detected before the error actually occurs, take preventive action. 5. Monitor and observe for any recurrence of the original problem, keeping in mind that there may be a systemic problem. 6. Provide information to all those who need it, and to those who are affected by the error. 164 Laboratory Quality Management System  14-4: Rectifying and managing occurrences Responsibilities The responsibility for monitoring for occurrences belongs to everyone in the laboratory. It is important, however, that someone be designated as the person responsible for marshalling the energies and activities of all staff into an effective management process. In many instances, this is the responsibility of the laboratory director, laboratory manager or quality manager. Laboratory Quality Management System 165  14-5: Summary Summary Occurrence management is an integral component of laboratory quality management. It establishes the methods for finding errors and preventing them from occurring again, and also seeks to identify potential errors and prevent them from happening. The laboratory should employ an active process for occurrence management and take a positive approach. Make an effort to detect problems as early as possible, and then take immediate remedial and corrective action. Be proactive and see opportunities to identify potential error, thus preventing an occurrence. Finally, keep good records of all problems, investigations and actions taken. Key messages The difference between a quality-managed laboratory and laboratories with no system in place is that the quality laboratory detects the problem, investigates and takes actions. 166 Laboratory Quality Management System 15. Process improvement  15-1: Continual improvement concept Role in quality Process improvement, one of the management 12 quality system essentials, establishes Organization Personnel Equipment system a programme for helping to ensure continual improvement in laboratory quality over time. This continual improvement of the laboratory Purchasing Process Information and processes is essential in a quality inventory control management management system. Documents Occurrence and Assessment management records Facilities Process Customer and improvement service safety Historical W. Edwards Deming is one of the originators of the concept of continual basis improvement, the primary goal of a quality management system. Beginning in the 1940s, he worked with manufacturing and industrial processes, and introduced many of the tools used in quality improvement efforts; his ideas and concepts are used today to produce reliable, quality laboratory results. Deming outlined 14 points for quality, many of which can easily be applied to the laboratory. For the purposes of this discussion, two of his points are particularly important: 1. Create constancy of purpose for improvement. The message here is that there is a need to be constantly working toward making the process better. 2. Improve constantly and forever. This statement points out that continual improvement will always be a goal. Perfection is never achieved, but we try to get as close to it as possible. Process improvement is something that is never finished, but rather continues on “forever”. Deming’s The Deming Plan-Do-Check-Act (PDCA) cycle shows how to achieve continual PDCA improvement in any process. cycle  Plan—identify the problems and the potential sources of system weakness or error. Decide on the steps to be used to gather information. Ask the question, “How can you best assess the current situation and analyze root causes of problem areas?” Using the information that is gathered through these techniques, develop a plan for improvement.  Do—implement whatever plans have been developed—put the plan into action. 168 Laboratory Quality Management System  15-1: Continual improvement concept Plan Act Do Check  Check—this refers to the monitoring process. It will be important to assess the effectiveness of the action taken, using focused review and audit processes. If the system weakness is complex, a pilot study may be needed in order to understand all the complexities. After “checking”, revise the plan as required to achieve the improvements needed.  Act—Take any corrective action that is required, and then recheck to be sure that the solution has worked.This cycle is a continuous process, so the laboratory will begin again with a planning process to continue the improvements. This is the continual improvement process and, in the laboratory, this process is applied to all procedures and processes that are a part of the path of workflow. ISO process ISO 15189 [4.12] describes a very similar set of activities for achieving continual for continual improvement in the laboratory. These are outlined as follows: improvement  identify potential sources of any system weakness or error;  develop plans to implement improvement;  implement the plan;  review the effectiveness of the action through the process of focused review and audit;  adjust the action plan and modify the system in accordance with the review and audit results. Laboratory Quality Management System 169  15-2: Tools for process improvement What is process A process is a series of actions or operations contributing to an end. In every improvement? case, inputs (patient samples) are turned into outputs (patient examination results) because some kind of work, activity or function is carried out. Process improvement is a systematic and periodic approach to improving laboratory quality and the inputs and outputs that glue these processes together. It is a way of solving problems. If there is a problem, however hard to describe, one or more processes needs to be improved. Conventional Many useful techniques have been developed to use in process improvement, and tools for some have been discussed in other chapters of this handbook. For example, both improvement internal and external audits will identify system weaknesses and problem areas. Participation in an external quality assessment is another useful tool; it allows for comparing laboratory performance to that of other laboratories. Management review of all information gathered through these activities should be conducted. In addition, there should be management reviews of the laboratory records on a regular basis; for example, quality control, inventory management and equipment maintenance. These reviews will provide useful information about areas for improvement. Quality plan Monitoring Monitoring Monitoring Quality Internal audit External audit Quality control assessment Opportunities for improvement Quality goal Using information from these reviews and from audits, and through the process of monitoring the organization’s customer complaints, worker complaints, errors, near errors or near misses, opportunities for improvement (OFIs) will be identified. These OFIs will be the focus for corrective action. 170 Laboratory Quality Management System  15-2: Tools for process improvement When conducting audits or evaluating laboratory records, it is important to have a goal or standard of performance. Therefore, quality indicators will be needed and will have an important role to play. The plan leads to the goals; OFIs, which are the result of monitoring, lead to the creation of a new plan, with the process leading to continual improvement. Newer tools New ideas for tools to use for continual improvement continue to come from the manufacturing industry. Two of these new tools are now being used in laboratory quality improvement. 1. Lean is the process of optimizing space, time and activity in order to improve the physical paths of workflow. This tool of industry is applicable to laboratories, and many laboratories are currently engaged in creating a lean system. Lean analysis may lead to revised processes and changes in laboratory floor plans. This should save time and financial resources, as well as help to reduce errors in the path of workflow. 2. Six Sigma is also a concept that has come to us from the manufacturing industry. This consists of a formal structure for project planning in order to implement change and improvement. In Six Sigma, the focus is to move toward reducing error to very low levels. The processes that are described in Six Sigma are define, measure, analyze, improve and control. These are similar ideas to those already discussed. The Six Sigma concept applies a very structured method for achieving these processes. (This chapter will not explore Six Sigma in depth; it is included here so that participants will become familiar with the term. See Chapter 15 reference list for sources of Six Sigma information.) Laboratory Quality Management System 171  15-3: Quality indicators Reminder: It is often useful to consider a number of definitions in order to make very clear What is quality? what is meant by a term such as quality. Philip Crosby, in his essays on quality management from the 1960s, defined quality as “conformance to requirements, not as ‘goodness’ or ‘elegance’”. What is a quality Established measures used to determine how well an organization meets needs indicator? and operational and performance expectations is a good working explanation of a quality indicator. Quality indicators are addressed in ISO 9001 and ISO 15189 documents. ISO 9001 [5.4.1] requires that quality objectives should be measurable. Thus, the objectives or indicators must be quantifiable or otherwise capable of analysis, allowing for an assessment of the success of the quality system. ISO 9001 [8.4] more specifically requires collecting and analyzing specific information or data upon which one can determine effectiveness and continual improvement. Some of the indicators that are required to be considered include customer satisfaction, conforming to customer requirements for products, counting the number of preventive actions addressed, and ensuring that suppliers are providing materials that will not adversely affect quality. ISO 15189 [4.12.4] states that the laboratory shall implement quality indicators to systematically monitor and evaluate the laboratory’s contribution to patient care. When the programme identifies opportunities for improvement, the laboratory management shall address them, regardless of where they occur. Also, it is stated that laboratory management shall ensure that the medical laboratory participates in quality improvement activities that deal with relevant areas and outcomes of patient care. Purpose of quality Quality indicators are information that is measured. The indicators: indicators  give information about the performance of a process  determine quality of services  highlight potential quality concerns  identify areas that need further study and investigation  track changes over time. 172 Laboratory Quality Management System  15-4: Selecting quality indicators General In selecting quality indicators for measuring performance, Mark Graham Brown, guidelines a leading expert on performance measurement, suggests the following useful guidelines.1  Fewer are better; that is, do not try to have too many quality indicators, as tracking becomes difficult. Few laboratories can effectively address more than five or six indicators at a single time.  Link the indicators to the factors needed for success. Choose the quality indicators that relate to areas that need correction in order to achieve good performance; select those that will be most meaningful to the laboratory.  Measures (indicators) should be based around customer and stakeholder needs.  Measures should look at all levels of the laboratory; if possible, include indicators that will evaluate function at the top management level, but also flow down to all levels of employees.  Measures should change as the environment and strategy changes. Do not stick with the same indicators over long periods of time.  Base the targets and goals for the measures on rational values, rather than values of convenience. They should be established on the basis of research rather than arbitrary estimates. Developing Quality indicators—also called metrics—are the specific targets that are regularly successful examined using objective methods, in order to determine if the goals of compliance indicators are being met. When developing quality indicators an organization should ensure the following.  Objective—the indicators must be measurable, and not dependent on subjective judgements. It must be possible to have concrete evidence that the event (or indicator) either occurs or does not, or that the target is clearly met.  Methodology available—be sure that the organization has the tools needed to accomplish the necessary measurements. The laboratory must have the ability to gather the information. If the data or information collection requires special equipment, then make sure the special equipment is available before starting.  Limits—the laboratory will need to know the acceptable value, including the upper and lower range, before starting measurements. Determine in advance the limits of acceptability, and at what point a result causes concern. Also consider what action will be required. For example, how many delayed reports per month would be considered acceptable? How many would be considered as requiring corrective actions? How many would require immediate revision of the action plan? 1 Brown MG. Baldridge award winning quality: How to interpret the Baldridge criteria for performance excellence. Milwaukee, ASQ Quality Press, 2006. Laboratory Quality Management System 173  15-4: Selecting quality indicators  Interpretation—decisions must be made as to how indicator information will be interpreted before beginning measurements. Know in advance how to interpret the information that has been collected. For example, if you are monitoring completed requisitions to see if they are correct, you need to know how many samples you have examined, if they have come from multiple sources or all sources, and whether they are for only one type of sample or all sample types.  Limitation—the organization should understand exactly what information is being provided by the indicator, and be clear on what is not being determined by the measurement of a particular indicator. For example, if collecting the number of accidents or errors, do you know if all are being reported?  Presentation—the organization must decide how to present the information in order to fully display its value. Some information is best presented in a table, whereas other information might be best shown by a longitudinal graphic bar or in text. Presentation of information is important when looking for trends that predict future outcome.  Action plan—before beginning the use of an indicator, the laboratory should have some idea of what to do if the indicator shows that there is a problem. Also decide how to collect the information, who will collect it, and how long it will be collected.  Exit plan—because making these measurements takes time and resources, there should be a plan as to when to stop using a particular indicator and replace it with another. Generally, this is done when the original indicator shows that the operation is working and stable. When developing quality indicators, be sure to engage the bench-level staff— those who do the work have a clear understanding of the tasks and outcomes. The planning process is best done in groups rather than by the quality manager alone. By engaging the people who actually do the work, the opportunity for success improves. Characteristics Good quality indicators (also called metrics) have the following characteristics: of good quality  measurable—the evidence can be gathered and counted; indicators  achievable—the laboratory has the capability of gathering the evidence it needs;  interpretable—once it is gathered, the laboratory can make a conclusion about the information that is useful to the laboratory;  actionable—if the indicator information reports a high or unacceptable level of error, it is possible to do something about the problem identified;  balanced—consider indicators that examine multiple aspects of the total testing cycle in the pre-examination, examination, and post-examination phases;  engaging—indicators should examine the work of all staff, not just one group;  timed—consider indicators with both short-term and long-term implications. 174 Laboratory Quality Management System  15-4: Selecting quality indicators The laboratory produces much information, but all the things that can be measured are not necessarily informative. As an example, a computer can analyze data in a variety of ways, but this does not always mean that the information is useful for continual improvement activities. Mark Graham Brown warns, “Many organizations spend thousands of hours collecting and interpreting data. However many of these hours are nothing more than wasted time because they analyze the wrong measurements, leading to inaccurate decision making”.1 Some examples All laboratories should consider implementing a process for using a set of of quality indicators which cover pre-examination, examination, and post-examination indicators issues, as well as patient care systems. A 2005 study of medical laboratories carried out in the United States showed the most commonly monitored indicators in use at that time were related to proficiency testing, quality control, personnel competencies, turnaround time, and patient identification and its accuracy.2 Most common indicators tracked (%), 2005 Patient identification Result turnaround time Competency of personnel Quality control Proficiency testing 40 60 80 100 It is important to note that, ideally, quality indicators used in health care should be linked to patient outcomes. However, this is very difficult with laboratory indicators because patient outcome is dependent upon a complex set of circumstances, including age and underlying illness, stage of illness, stage of diagnosis and stage of therapy. Therefore, laboratories often use quality indicators other than health outcomes of patients. 1 Brown MG. Using the right metrics to drive world-class performance. New York, American Management Association, 1996. 2 Hilborne L. Developing a core set of laboratory based quality indicators. Presented at Institute for Quality in Laboratory Medicine Conference, Centers for Disease Control and Prevention, Atlanta, GA United States, 29 April 2005 (http://cdc.confex.com/cdc/ qlm2005/techprogram/paper_9086.htm). Laboratory Quality Management System 175  15-5: Implementing process improvement Essentials for Regardless of the technique used, continual improvement requires action from implementation the people within the organization. Some of the necessary steps are important management roles, and others require the entire laboratory staff for success. These essential factors and steps include:  Commitment from all levels of the laboratory staff. Improvement requires continual awareness and activity. This is a full-time task and requires dedicated staff time.  Careful planning so that goals can be achieved. Before action plans are implemented, there is much to consider: root causes of error; risk management; failures, potential failures and near misses; costs, benefits and priorities; and the costs of inaction.  An organizational structure that supports the improvement activities.  Leadership—top management must be engaged and supportive.  Participation and engagement of the people that normally perform the tasks being addressed.These are the staff most likely to know and understand what is done on a regular and daily basis, and without their participation, improvement programmes have little opportunity for lasting success. Planning When undertaking and implementing action plans for quality improvement, there for quality are a number of factors to consider. improvement  What are the root causes of error? In order to correct errors, it is important to identify the root causes, or underlying causes, of the problem.  How will risk be managed in the laboratory? Risk management takes into account the trade offs between the risk of a problem, and the costs and effort involved in fixing it.  Failures, potential failures and near misses are categories into which laboratory problems fall. Failures are most commonly identified, as a failure in the system will usually be immediately obvious. Failures need to be addressed as a part of continual improvement. However, a good process improvement programme will try to identify potential failures, which are not so obvious, as well as near misses (those situations where a failure has almost occurred).  Any process improvement programme must take into account the costs of making changes, the benefits of making the changes and the priorities for action. These decisions relate to the concept of risk management.  Finally, it is important to consider the cost of inaction, or failure to take action. What will be the cost, in money, time or adverse effects, of not correcting a problem in the laboratory quality system? Role of leadership Early on, Deming observed that quality managers working without the clear, active, and open participation of top management cannot succeed in implementing continual improvement. Sustained leadership must come from the top. 176 Laboratory Quality Management System  15-5: Implementing process improvement Good leadership fosters the culture for improvement, including:  openness—the process must be understood by all and there must be a recognition that all laboratory staff will have good ideas to help with improvements.  commitment—it must be clearly communicated that there is support for the process and that improvements will occur.  opportunity—a good leader will ensure that all staff have the opportunity to participate in the process. Participation in Always remember that top management, quality managers and consultants do the process not know everything that the bench-level staff know, and often are not aware of all of the staff’s tasks. It is vital to engage all bench-level staff in the process improvement programme, as their knowledge and support are also essential. Furthermore, when staff know they can make a difference, they will benefit the laboratory by pointing out potential problems that can be avoided. Continual improvement requires both leadership and engaged team participation. The following steps show how to plan quality improvement activities: Quality  use a timeline and do not take on more than can be accomplished within a improvement timeframe; activities  use a team approach, involving bench-level staff;  use appropriate quality improvement tools;  implement corrective or preventive actions;  report quality improvement activities, findings and corrective action progress to management and also to laboratory staff. 2008 2009 ID activity I II III IV I II III IV 1 Specimen collection—haematology 2 ELISA turnaround time 3 Physicians complaints—AFB smears 4 QC of chemistry instruments If possible, design a study so that results can be statistically measured. Use available information to select a topic for study, for example:  customers' suggestions or complaints  identified errors from occurrence management programme  problems identified in internal audits. Consider as a guideline to have no more than one project every six months. Retiring a Use a quality indicator only as long as it provides useful information. Once it is quality indicating a stable and error-free operation, select a new quality indicator. indicator Laboratory Quality Management System 177  15-6: Summary Continual The process for continual improvement includes: improvement  identification of the problem;  analysis of the data and the processes;  determination of the root cause of the problem;  generation of ideas for solutions. The quality cycle Plan Each step is essential to keep the quality cycle cycling Act Do CHECK Continual improvement is the core of quality management, but it requires commitment, planning, structure, leadership, participation and engagement. Key  Quality counts—it is a very important goal for any laboratory. messages  Continual improvement is an outcome of an active laboratory quality management system. 178 Laboratory Quality Management System 16. Documents and records  16-1: Introduction Role in quality The management of documents and management records is one of the 12 essential system elements of the quality system. The Organization Personnel Equipment management system addresses both use and maintenance of documents and records. A major goal of keeping Purchasing Process Information documents and records is to find and inventory control management information whenever it is needed. Documents Occurrence and Assessment management records Facilities Process Customer and improvement service safety Documents Documents provide written information about policies, processes and procedures. and records— Characteristics of documents are that they: what are the  communicate information to all persons who need it, including laboratory staff, differences? users and laboratory management personnel;  need to be updated or maintained;  must be changed when a policy, process or procedure changes;  establish formats for recording and reporting information by the use of standardized forms—once the forms are used to record information, they become records. Some examples of documents include a quality manual, standard operating procedures and job aids. Records are the collected information produced by the laboratory in the process of performing and reporting a laboratory test. Characteristics of records are that they:  need to be easily retrieved or accessed;  contain information that is permanent, and does not require updating. Some examples of records include completed forms, charts, sample logs, patient records, quality control information and patient reports. Information is the major product of the laboratory, so manage it carefully with a good system for the laboratory’s documents and records. 180 Laboratory Quality Management System  16-2: Overview of documents Documents include all the written policies, processes and procedures of the laboratory. In order to develop laboratory documents, it is important to understand each of these elements and how they relate to each other. What is a A policy is “a documented statement of overall intentions and direction defined policy? by those in the organization and endorsed by management”.1 Policies give broad and general direction to the quality system. They:  tell “what to do”, in a broad and general way;  include a statement of the organizational mission, goals and purpose;  serve as the framework for the quality system, and should always be specified in the quality manual. Although there are national policies that affect laboratory operations, each laboratory will develop policies specific to its own operations. What is a Processes are the steps involved in carrying out quality policies. ISO 9000 [4.3.1]2 process? defines a process as a “set of interrelated or interacting activities that transform inputs into outputs”. Some examples of laboratory inputs include test requests, samples, and requests for information. Examples of laboratory outputs include laboratory data and reports of results. Using these examples, one process might be how to transform a test request (input) into a test result (output). Another way of thinking about a process is as “how it happens”. Processes can generally be represented in a flow chart, with a series of steps to indicate how events should occur over a period of time. What are Procedures are the specific activities of a process (ISO 9000 [3.4]). Procedures are very procedures? familiar to laboratorians—a procedure is easily described as the performance of a test. A procedure tells “how to do it”, and shows the step-by-step instructions that laboratory staff should meticulously follow for each activity. The term standard operating procedure (SOP) is often used to indicate these detailed instructions on how to do it. Job aids, or work instructions, are shortened versions of SOPs that can be posted at the bench for easy reference on performing a procedure. They are meant to supplement, not replace, the SOPs. 1 CLSI/NCCLS. A quality management system model for health care; approved guideline—second edition. CLSI/NCCLS document HS1-A2. Wayne, PA, NCCLS, 2004. 2 ISO 9000:2005. Quality management systems—fundamentals and vocabulary. Geneva, International Organization for Standardization, 2005. Laboratory Quality Management System 181  16-2: Overview of documents Document A good way to represent the relationship of policies, processes and procedures hierarchy is as a tree. The policies are represented by the roots, and they form the base for all the other parts. The processes can be viewed as the trunk of the tree, representing a series of steps or flow of actions through the laboratory.The leaves of the tree can be thought of as the procedures; there will be many procedures in the laboratory for accomplishing the activities or the work. The quality manual is the overall guiding document that defines the quality system through policies established by the laboratory. Next in the hierarchy of documents are the processes, the sets of activities. Procedures either flow from processes, or make up a part of a process; these will generally be described as SOPs. Work instructions or job aids are shortened versions of SOPs. Finally, forms are used to record results; when completed, they become records. Why are Documents are the essential guidelines for all of the laboratory operations.Some of documents the important documents that every laboratory should have include: important?  Quality manual—this is the overall guiding document for the quality system and provides the framework for its design and implementation. A laboratory is required to have a quality manual for ISO accreditation (the quality manual is discussed further in sections 16-3 and 16-4).  SOPs—SOPs contain step-by-step written instructions for each procedure performed in the laboratory. These instructions are essential to ensure that all procedures are performed consistently by everyone in the laboratory.  Reference materials—good reference materials are needed in order to find scientific and clinical information about diseases, laboratory methods, and procedures. Sometimes, there are difficult interpretive issues, for which references or textbooks will be needed. As an example, when examining samples microscopically for parasites, photographs and descriptive information can be very helpful. Written documents are required by formal laboratory standards, including those leading to accreditation. Standards generally require that policies and procedures be written and available. Most inspection or assessment activities include an examination of the laboratory’s documents. The documents are an important element on which the laboratory is assessed. 182 Laboratory Quality Management System  16-2: Overview of documents Documents are the communicators of the quality system. All policies, processes and procedures must be written, so that everyone will know the proper procedures and can carry them out. Verbal instructions alone may not be heard, may be misunderstood, are quickly forgotten and are difficult to follow. Everyone, both inside and outside the laboratory, must know exactly what is being done and what should be done at each step. Therefore, all of the guidelines must be written so that they are available and accessible to all who need them. Documents are a reflection of the laboratory’s organization and its quality management. A well-managed laboratory will always have a strong set of documents to guide its work. A good rule to follow is “Do what you wrote and write what you are doing”. What makes Documents communicate what is done in the laboratory. Good documents are: a good  written clearly and concisely—it is better to avoid wordy, unnecessary document? explanations in the documents;  written in a user-friendly style—it might be helpful to use a standard outline so the general structure will be familiar to staff and easily used by new personnel;  written so as to be explicit and accurate, reflecting all implemented measures, responsibilities and programmes;  maintained to ensure that it is always up to date. Accessibility The documents needed in the work process must be accessible to all staff. Persons managing samples should have the procedures for sample management directly available to them. Testing personnel will need the SOPs in a convenient place, and perhaps a job aid posted in clear view of the workspace where testing is performed. The testing personnel need immediate access to quality control charts and troubleshooting instructions for equipment. All staff must have access to safety manuals. Laboratory Quality Management System 183  16-3: The quality manual What is a quality The quality manual is a document that describes the quality management system manual? of an organization (ISO 15189). Its purpose is to:  clearly communicate information  serve as a framework for meeting quality system requirements  convey managerial commitment to the quality system. As the quality manual is an important guide or roadmap, all persons in the laboratory should be instructed on its use and application. The manual must be kept up to date, and responsibility for the updating should be assigned. Writing a quality Although ISO 15189 standards require that laboratories have a quality manual, manual the style and structure are not specified. There is considerable flexibility in how to prepare it, and a laboratory can construct the manual so that it is most useful and suited to the needs of the laboratory and its customers. When writing a quality manual, it is a good idea to use a steering committee. Because the quality manual needs to be tailored to the specific needs of the laboratory, each facility should carefully consider how to best involve those who are needed. Involve the policy makers for the laboratory. It is also essential to involve the bench technologists, to take advantage of their expertise and get their buy-in. The quality manual should state policies for each of the twelve essentials of the quality system. Also describe how all the related quality processes occur, and make note of all versions of procedures (SOPs) and where they are located. For example, SOPs are a part of the overall quality system. Although there are usually too many to include directly in the quality manual, the manual should specify that SOPs be developed and indicate that they be compiled in the SOP manual. Key points The key points to remember about the quality manual are: there is only one official version the quality manual is never finished—it is always being improved it should be read, understood and accepted by everyone it should be written in clear, easily understood language the quality manual should be dated and signed by the management. Developing a quality manual is a very big job, but it is also very rewarding and useful for the laboratory. 184 Laboratory Quality Management System  16-4: Standard operating procedures (SOPs) What is SOPs are also documents, and contain written step-by-step instructions that an SOP? laboratory staff should meticulously follow when performing a procedure. A laboratory will have many SOPs, one for each procedure conducted in the laboratory. Written SOPs ensure the following.  Consistency—everyone should perform the tests exactly the same way so that the same result can be expected from all staff. Consistency enables people who use laboratory results to observe changes in a particular patient’s results over time. If different laboratories use the same SOPs, comparisons of their results can be made; it should be emphasized that all laboratory staff must follow the SOPs exactly.  Accuracy—following written procedures helps laboratory staff produce more accurate results than relying on memory alone because they will not forget steps in the process.  Quality—consistent (reliable) and accurate results are primary goals of the laboratory, and could be considered as the definition of quality in the laboratory. A good SOP should be:  detailed, clear and concise, so that staff not normally performing the procedure will be able to do so by following the SOP—all necessary details (e.g. ambient temperature requirements and precise timing instructions) should be included;  easily understood by new personnel or students in training;  reviewed and approved by the laboratory management—approval is indicated by a signature and a date (this is important to ensure that the procedures being used for testing in the laboratory are those that are up to date and appropriate);  updated on a regular basis. Standardized It is a good idea to standardize the formats of SOPs so staff can easily recognize format the flow of the information. Headers are a very important part of the format. Below are examples of two different types of headers that could be used when writing an SOP.  Complete standardized header—typically the standardized header would appear on the first page of each SOP. The standardized form makes it easy for staff to quickly note the pertinent information. Laboratory Quality Management System 185  16-4: Standard operating procedures (SOPs) TLM/MSH Microbiology Department Policy # MI/RESP/11/v05 Page 1 of 5 Policy & Procedure Manual Section: Respiratory Tract Culture Manual Subject Title: SPUTUM (Including Endotracheal Tube and Tracheostomy Specimens) Issued by: LABORATORY MANAGER Original Date: September 25, 2000 Approved by: Laboratory Director Revision Date: September 14, 2006 Annual Review Date: August 13, 2007  Reduced standardized header—this standardized form includes a smaller version of the header that would appear on all pages other than the first. TLM/MSH Microbiology Department Policy # MI/RESP/11/v05 Page 2 of 5 Policy & Procedure Manual Respiratory Tract Culture Manual Preparing There are a few things to keep in mind when preparing an SOP. Firstly, it is SOPs important to assess the scientific validity of the procedure.Then, when writing the procedure, include all steps and details explaining how to properly perform the procedure. The SOP should refer to any relevant procedures that may be written separately, such as instructions for sample collection or quality control. Finally, a mechanism should be established for keeping SOPs updated. SOPs should include the following information:  title—name of test;  purpose—include information about the test (why it is important, how it is used, and whether it is intended for screening, to diagnose, or to follow treatment and if it is to be used for public health surveillance);  instructions—detailed information for the entire testing process, including pre- examination, examination and post-examination phases;  name of the person preparing the SOP;  signatures of approving officials and dates of approval—it is necessary to follow the laboratory’s quality policy and regulatory requirements. Pre-examination instructions should address sample collection and transport to the laboratory, and conditions needed for proper sample handling. For example, instructions should indicate whether the sample needs a preservative, and whether it should be refrigerated, frozen, or kept at room temperature. Instructions should also reflect laboratory policies for sample labelling, such as requirements to verify more than one type of patient identification, to write the collection date on the sample label, and to make sure all information needed is included on the test request form. 186 Laboratory Quality Management System  16-4: Standard operating procedures (SOPs) Examination instructions should address the actual step-by-step laboratory procedures to follow and the quality control procedures needed to ensure accuracy and reliability. Post-examination instructions should provide information on reporting the results, including the unit of measurement to be used, the normal (reference) range, ranges that are life-threatening (sometimes called “panic values”) and instructions for how to deal with an urgent report. They should also include references to the published sources of the procedures, including published evidence that the procedures are scientifically valid. Manufacturer’s The instructions that manufacturers provide in their product inserts tell how instructions to perform the test, but do not include other important information that is specific to laboratory policy, such as how to record results, algorithms outlining the sequence of testing and safety practices. The manufacturer’s instructions may describe recommended quality control procedures for the test, but the recommendations may not be as comprehensive as protocols that a laboratory has put into place. Do not rely solely on manufacturer product inserts for SOPs. Use information from these inserts, but develop SOPs specific to your laboratory. What is a A job aid is a shortened version of an SOP. It is designed for use directly at the job aid? testing site. It should be placed in a visible location, and serves as a reminder of the steps that need to be completed. The job aid and the SOP must include the same instructions. If a job aid is distributed to sources outside the laboratory, ensure that the information illustrated matches that which is instructed in the SOP. External laboratory assessors often check to see if job aids and SOPs are in accordance. Job aids supplement—not replace—the SOP. They do not include all the details that are provided in the SOP. Laboratory Quality Management System 187  16-5: Document control Purpose of Documents, by definition, require updating. A system must be established for document managing them so that current versions are always available. A document control control system provides procedures for formatting and maintaining documents and should:  ensure that the most current version of any document is the one that is in use;  ensure availability and ease of use when a document is needed;  provide for the appropriate archiving of documents when they need to be replaced. Elements of A document control system provides a method for formatting documents so that document they are easily managed, and sets up processes for maintaining the inventory of control documents. In this system the laboratory will need:  a uniform format that includes a numbering system, to include a method for identifying the version (date) of the document;  a process for formal approval of each new document, a distribution plan or list, and a procedure for updating and revising laboratory documents;  a master log or inventory of all documents of the laboratory;  a process to ensure that the documents are available to all who need them, including users outside the laboratory;  a method for archiving documents that become outdated but need to be kept for future reference. Controlled All documents that are produced by and/or used in the laboratory must be documents included in the control system. Some important examples include:  SOPs—these must be up to date, showing the procedures that are in current use and, when work instructions or job aids are used, they must exactly match the SOPs for the tasks described;  texts, articles and books that are part of the documents referenced in a laboratory;  documents of external origin, such as instrument service manuals, regulations and standards, and new references (that may change over time). While establishing a document control programme, the following should be considered.  A system for standardizing the format and/or numbering—it is very useful Developing to have a numbering or coding system that applies to all documents created the document within the organization. Because documents are “living” and require updating, control system the numbering system should indicate the document version. - One suggestion for a numbering system is to use a letter for the type of document, then an incremented number for each of the documents of this type. All pages of the documents would contain the appropriate number. For example, B1, B2, B3, … for books ; T1, T2,... for official texts. A location code could be used, and would be useful for the master log or file. For example, “Book number 2, pages 188–200, on bookshelf 1” B2, 188–200, BS1. 188 Laboratory Quality Management System  16-5: Document control - Establishing a document numbering system can be a difficult and time- consuming process. If the laboratory already has an effective system in place, there is no need to change it.  Approval, distribution and revision process—control of documents requires that they be reviewed on a regular basis, with revision as needed, followed by approval and distribution to those who need them. The review and approval process is generally performed by laboratory management, and approval is indicated by signatures with appropriate d