Quality Management within a laboratory involves managing the 12 Quality System Essentials according to the requirements stated in the ISO 15189 standard. Initiatives like SPLITA and SLMTA have made great strides in improving laboratory quality and helping laboratories work towards accreditation in resource-limited settings e.g. Sub-saharan Africa. Since this means using available resources to meet the requirements, most of the processes are completed manually. Quality management in developed countries like Australia and the USA has the advantage of automated systems and software, accreditation can be easier to achieve.
The advantages of a manual quality management system
1. Enables better understanding of the quality system requirements
My experience mentoring laboratories using manual methods gave me a better understanding of the requirements of the quality management system standard, as they were not already embedded in a pre-built system.
2. Requires less resources
Less resources are required for upfront procurement of the system and ongoing maintenance. However it can be argued that too many resources are expended in implementing and maintaining manual systems.
The disadvantages of a manual quality management system
1. Tedious and time consuming
Manual quality management systems are highly tedious, with highly skilled laboratory staff spending a lot of time managing the system that could be spent elsewhere.
2. High risk of error
Apart from being highly tedious, this way of doing things is also highly prone to error. A good example is document control which involves manually inputting document control features, managing document versions as well as keeping records of document acknowledgement as versions change. Another example is handling of non-conformities which involves having a hard copy form where all non-conformities are recorded including the root cause analysis and the corrective action.
3. High volume of paper records
Management of paper documents and records-Think current and obsolete controlled documents, all completed forms (records) that have to be stored in files until the stipulated document retention period is over. Storing paper copies requires a lot of physical space which laboratories may not have.
What is a Quality Management Software
A Quality management system software (QMSS) is a technology product or business system, that organisations use to record, report and analyse processes. The software can be generic or customised to specific industries, most organisations seeking certification and/or accreditation to quality based ISO standards can use a QMSS. It automates the quality management processes to overcome some of the cons of manual systems. A typical QMSS has the following functions but can be customized according to customer needs:
Management of Non-Conformities
Advantages of a Quality Management System Software (QMSS)
Quality Management software automate quality management functions leaving the team with more time to devote to other areas of laboratory operations including meetings to discuss continuous improvement.
1. Planning and scheduling
The QMSS allows quality management system tasks e.g. equipment maintenance, document review and audits which are fairly regular tasks to be scheduled. This pro-active approach to quality management where important tasks are planned and assigned to relevant people also increases the chances of tasks being completed on time.
The QMSS can be configured to alert users via email before due date of completion of task, when the task becomes due and also when a task is overdue. Laboratory staff are often busy with day to day laboratory work and these email alerts are critical to ensuring tasks do not get forgotten.
3. Records Management
Managing quality and technical records can be a daunting task, manually this involves having folders for each element e.g. equipment folders would hold all the information about the equipment and all the service records for that equipment. Other records would include staff records of training and competency, temperature monitoring charts, records of validation/verification of new tests and pre-acceptance checks on reagents. Apart from being cumbersome, often offices can become too small to hold all these records over time. There is also a risk of the loss of records to fire or other elements. QMSS can hold records indefinitely and ensure their safety through things like backup servers and use of the cloud to host the system.
Using a QMS it is easy to search for a record using a keyword and that record can easily be retrieved. Imagine trying to find a non-conformity record about Gram stain reagents and you do not remember when that Non Conformity (NC) happened. This would involve flipping through pages and pages on NC reports to locate the correct one. Using a QMSS typing the word Gram would bring up all the Gram NCs and the search is more streamlined.
5. Review of documents and records
Management Review is an important element of quality management. To avoid moving paperwork from one person to another and from lab to office etc. , the report can be uploaded to the QMSS and assigned reviewers. The QMSS makes these reviews very easy, merely assigning that review to the relevant manager means the manager will get a notification and access that record to review from the comfort of their office. Quality personnel no longer have to spend time looking for these managers who are often busy in meetings outside their office. Management review reports can be easily compiled as information is all in one place.
6. Monitoring and reporting on Key Performance Indicators
The QMSS which can be configured to produce graphs, charts and trend analysis reports for key metrics. This gives visibility over the operations in the laboratory and allows managers to view and monitor key metrics. Reports can be exported to excel, pdf or other means such and further analysed as required.
Challenges in acquiring Quality Management Software Systems
Quality Management Software are clearly important in simplifying quality management for laboratories and other organisations seeking certification and/or accreditation to various standards, however there are still some challenges with having QMSS especially in resource limited settings
Cost– Most of these systems are quite expensive, depending on how many users the system is expected to support. Building a QMSS as with building any system requires software development expertise as well as expertise in the subject matter
Internet availability and speed-Most of the systems are hosted in cloud or local servers, internet connection is required to access the system, in remote settings where internet connection is not consistent nor available this would be a major hindrance
Hardware- Laboratories need computers to access the QMSS
System Maintenance-The systems have to be maintained to ensure they remain up and do not inconvenience the users when they need the system, as a bad system may be worse than no system.
It seems prudent to invest in Quality management software systems to make the implementation of QMSS easy on staff. It saves time so that this time can be invested in the important valuable skills that staff have been trained on to provide a quality result to the patient. The risk that is inherent in this process should give management the drive to look into suitable affordable QMSS for their organisations.