Different types of testing
Laboratories are divided into three types: first-, second- and third-party testing.
First-party testing
This is where a manufacturer or supplier has internal systems wherein it tests and verifies the quality of its own product.
Second-party testing
This is testing performed by a buyer, user, retailer, etc. For example, it can be a client who has bought some products that are produced by an external factory and the contract between them states that the customer monitors the quality of the products supplied to them. Alternatively, it could be a governmental organisation that wants to monitor the quality of a product offered to citizens, or a party that buys products for the benefit of others and owns a laboratory.
It could also be an entity that leases its trademark for the benefit of others, and that entity owns a laboratory to verify that the products on which its trademark is placed conform to the specifications stipulated in the contract agreed between the supplier and themselves.
Third-party testing
This is an independent laboratory that does not follow any party and invokes its results in the event of a difference in viewpoints between the laboratory and the client. For example, a government agency may want to monitor products sold in the market to citizens, so it resorts to a ‘neutral’ laboratory far from the authority of the service provider. This type of laboratory is frequently used if results are likely to have a significant impact on public or societal issues in terms of health, environment, safety and/or economics.
Technical requirements
Documentation and equipment
Your lab must include a quality manual that documents its practices and the specific steps taken to ensure quality testing. The manual must contain or refer to documentation that describes and details the laboratory’s implementation of procedures covering all technical requirements. This will illustrate the correct methods for carrying out specific tasks and should be used during training and as a general reference guide.
It’s important to ensure your equipment is fit-for-purpose, but you must also make certain to properly manage your tools, otherwise you may find that results are inaccurate and time consuming regardless of their propriety.
Before equipment is installed, you must verify that all physical requirements (electrical, space, doors, ventilation and water supply) have been met. After the equipment has been installed, the following details must be addressed before putting the equipment into service:
- Assign responsibility for performing the maintenance and operation programmes
- Develop a system for recording the use of parts and supplies
- Implement a written plan for calibration, performance verification and proper operation of the equipment
- Establish a scheduled maintenance programme that includes daily, weekly and monthly maintenance tasks
- Provide training for all operators; only personnel who have been trained specifically to properly use the equipment should be authorised as operators.
Sampling
When it comes to sampling, there are several important pieces of information a laboratory must collate.
The first step in the process of obtaining the sample is the request for testing. The laboratory must make available a test request form that specifies all the information that will be needed for proper handling and reporting, each sample being clearly labelled. The laboratory should also establish rejection criteria; if samples are rejected these should be recorded in the logbook and include all pertinent details.
It is crucial that the technician handles the sample appropriately and this may need to be adjusted depending on the nature of the sample. Storage is also a vital consideration; written policies should be developed and include the following information:
- Description of what samples should be stored
- Retention time
- Location (consider ease of access)
- Conditions for storage, such as atmospheric and temperature requirements
- System for storage organisation – one method is to store samples by day of receipt or accession number.
Some samples can be quickly discarded, while others may need to be retained for longer periods. Monitor stored samples and do not keep them for longer than necessary, as refrigerator and freezer space may be limited. Sample freeze/thaw cycles must be monitored, as samples may deteriorate under these conditions. The laboratory is also responsible for ensuring that disposal of all laboratory waste is handled safely.
The transportation of samples must also be considered. Such regulations come from several sources, including national transport regulations from the International Civil Aviation Organization (ICAO), as conveyed by the International Air Transport Association; rail and road traffic agencies and postal services.1
Management and organisational requirements
The main element for a successful quality management system is efficient leadership and the company’s systems must be structured and organised with its quality goals in mind. It is important to note, however, that the quality management system is an on-going activity that requires continuous improvement and adaptation.
A quality management system outlines the specific responsibilities of managers. Management must be responsible for establishing the policies and processes of the quality system, ensuring all policies, processes, procedures and instructions are documented. They are also responsible for making sure that all personnel understand the necessary documents, instructions and their duties, and must provide them with the appropriate authority and resources to carry out their role.
Laboratory leaders must be fully committed to the implementation of the system, and will need vision, team building and motivational skills, good communication techniques, and the ability to use resources responsibly. The structure of the organisation should be clearly defined and this should be reflected by a functional organisational chart, with a clear assignment of responsibility.
Preparation for such systems is key; the lab leader should create a plan which clearly maps out timeframes, who is responsible for each activity and who will be managing the workflow, as well as the use of human and financial resources.
As components of the quality management system are put in place, processes for monitoring will be needed to ensure that the system functions properly and that benchmarks and standards are being met.
Duties in the lab
Management is charged with providing a quality manual that describes the quality management system. The quality manual outlines how policies are established and communicated to the staff and laboratory users.
Laboratory directors have principal responsibility for setting up an organisation that can support the quality system model. They are responsible for developing policies, assigning responsibility to the appropriate persons, ensuring resources and reviewing the organisational aspects of the system for optimal functioning of quality processes. They must ensure that staff follow the quality policies outlined in the quality manual.
Quality managers assist in developing policies, planning and implementing the quality management system. They are usually responsible for many of the implementing and monitoring processes and must communicate all aspects of the quality management system processes to the laboratory director or head of the laboratory.
Laboratory staff are responsible for understanding the organisational structure of the laboratory, including where authority and responsibility are assigned. The laboratory staff will follow all of the quality policies in their daily work routine.
Financial requirements
Financial information is typically the most important aspect for the interested stakeholders. It will also serve as a means to measure the financial projections against actual financial information if the feasibility study is implemented.
Several financial statements should be included in the proposal. An income statement, cash flow statement and balance sheet will indicate the viability of the new business. All expenses should be included in the financial projections.2
Marketing plan
Having a strong marketing strategy is imperative, not only in terms of how you plan to capture the market but also how you intend to grow. This can be divided into the four Ps – product, price, plan and promotions.
Examples:
- Offering long-term contract packages
- Express analysis fees
- Widening your laboratory’s scope of analysis
- Via the website, social media and events.
This is an important factor to understand as it may be necessary to include in the financial pro forma when considering direct and indirect costs.
Finally, be aware of who your demographic is, as your service area is an important choice and can dictate your offering.
About the author
Abdelrhman Youssef is a Chemist and Microbiologist working for Intertek Testing Services – Caleb Brett Egypt Ltd – Agriculture Laboratory. Youssef graduated from Alexandria University with a Bachelor of Science in (Major) Chemistry and (Minor) Physics. Prior to his current role at Intertek, he worked as a Quality Control Chemist for a pasteurised liquid egg plant. He has experience in inspection, manufacturing, auditing processes and instrument calibration and has specific knowledge of quality improvement principles.
References
- ISO 15194, In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation
- Hass KB. (2008). The Business Analyst as Strategist: Translating Business Strategies into Valuable Solutions. Vienna, VA: Management Concepts
