In order to be efficient and productive in any laboratory, there must be a system of organization in place. There is equipment to be maintained and calibrated, reagents to be ordered and inventoried, samples to be analyzed and data to be managed, reviewed and stored. A contract laboratory has many other special considerations to be made. There are client confidentiality and proprietary issues, sample tracking and client expectations to be met. Although it is a challenge, a contract laboratory can meet and exceed customer expectations while also meeting deadlines, maintaining compliance, preserving data integrity and delivering high quality laboratory service. This is made possible by employing simple time saving efficiency techniques that will aid in maintaining an organized laboratory and keepin an operation running smoothly. Implementing organizational techniques saves time overall and helps reduce redundancy and waste, while serving to lower operating costs. A well-organized laboratory shows clients that the service provider cares about their products and is well prepared to serve each client’s needs in an orderly and efficient manner.
In the pages that follow, I’d like to offer a number of efficiency tips for contract laboratories to employ in order to serve their clients better, as well as some suggestions for clients to consider when searching for and negotiating with contract laboratories.
Clients are very concerned about what is going to happen to their product when it arrives in a contract laboratory. They want to know what the lab’s sample-handling procedure is going to be from start to finish. They want to feel secure that their proprietary concerns will be dealt with in a professional manner. Sample tracking is a means of combining these considerations into a simple, smooth and organized procedure.
• Create a sample database. Upon arrival of a sample into the laboratory, it should be formally entered or logged into a sample receipt database. By documenting the receipt of the sample, the lab now has a record of it arriving for analysis. It has become part of the laboratory “system.”
• Provide samples with unique identification. Establish a system of identifying samples with unique generic symbols or numbers. By applying an identifier to a sample, the staff has a means of referencing each sample throughout the laboratory without compromising client confidentiality. The sample can be cross-referenced into any necessary equipment logbooks that could be reviewed by other clients.
• Formally release samples. After sample analysis has been completed, the sample should be formally released from the laboratory in the sample database. Notebook references could also be added for ease in data retrieval later.
Although it may seem a bit tedious to implement at first, the sample database becomes an invaluable resource for laboratory data management. It is easy to reference for determining the number of samples performed during a particular time period. This can aid in ordering laboratory supplies and reagents or calculating what percentage of lab work comes from a particular client. It serves as an up-to-the-minute record of ongoing and completed work within the laboratory. For laboratories employing many analysts, it can help to eliminate confusion about what work has been performed or not, while keeping samples from being unnecessarily performed in duplicate or not at all.
Equipment Maintenance and Calibration
Clients need to feel secure that any equipment used to analyze their products is properly maintained and calibrated. They also want to know that the equipment is operating optimally and that any data derived from use of a particular laboratory instrument is valid and accurate. It is the laboratory’s responsibility to maintain equipment, use only properly installed and calibrated equipment and record all equipment usage in the appropriate laboratory logbooks. It can become an amazing amount of information to keep track of, so here are some tips on keeping track of it all.
• Create an equipment database. It is essential to keep track of equipment maintenance and calibration. Developing an equipment database will help to keep this information organized in such a way as to be able to keep constant track of equipment that is due for maintenance or calibration. A spreadsheet format for this type of database works extremely well. The equipment can be entered with all serial numbers, date of last calibration and due date of next calibration.
• Update equipment database regularly. The database should be updated as additions of equipment to the laboratory are made and as maintenance and calibrations are performed. The database will be only as effective as it is accurate. What makes this extremely helpful is that, regardless of how many extraneous equipment logbooks there might be throughout the lab, or files of calibration data to be stored, the equipment database is a small and efficient summary that can be quickly accessed and used to schedule or plan equipment service.
• Plan and schedule equipment service. Upon making an entry or update in the equipment database, the spreadsheet can be used to update your laboratory planning calendar.
• Plan 12 months in advance. Obtain a large 12-month calendar and place it in a highly visible and accessible location in the laboratory. A formatted dry-erase board can work well, as it can easily be updated and reused. Mark on the calendar month by month to display what equipment is due for scheduled maintenance or calibration. In this fashion, lab personnel will know well in advance when to have outside service contractors scheduled or when to arrange their own schedules to perform the service themselves. The calendar can also be used to display project timelines, personnel vacations or other events, such as training. This is a cost effective and visible planning tool for laboratory personnel.
It is very distressing for an analyst to prepare a sample for testing, only to discover that the equipment needed for analysis has passed its calibration due date, and subsequently to find out that it will be two weeks before a service contractor can service the equipment. Planning ahead can prevent this situation from occurring. An equipment database spreadsheet is a smart planning tool.
A client needs to know that any documentation performed for its product will retain proprietary confidentiality. Clients want to be sure that all necessary documentation is being performed, but is not being viewed by competitors. Establishing and applying unique sample identifiers helps but does not eliminate the confidentiality issue entirely. The following suggestions can help labs protect confidentiality.
• Separate client data. Never allow data for one client to be even potentially viewed by another. Assigning a separate laboratory notebook for each client should prevent breaches of confidentiality. Ensure that there are no cross-references between notebooks assigned to different clients.
• Establish a common solutions notebook. Of course, there are times that the same solution is needed for different clients. For example, the lab may need to prepare a USP test solution for analyzing Client X’s product, but also need that same solution to analyze a sample for Client Z. Cross-referencing the solution preparation from one client notebook into another client notebook should not be permitted. Instead of preparing the solution twice, once per client, it is easier to have a generic laboratory notebook to document the preparation of commonly used laboratory solutions. The solution can then be referenced in both client notebooks from the generic notebook origin. Either client can freely examine the generic notebook without compromising the other’s confidentiality. This results in savings of both time and money for the laboratory.
• Implement a universal laboratory notebook format. Everyday notebook documentation for a client can be organized with minimum effort for maximum benefit later. It is best to develop a format that will be used by all laboratory personnel. This will speed up notebook review and auditing turnaround time. An established format enables the lab to retrieve data quickly, because all data will be presented in the same format, regardless of analyst, sample or client. Notebook review should also become more effective; a reviewer will more easily discover any data accidentally omitted by the analyst. Faster notebook review results in the notebook being available to the analyst sooner, permitting further testing for that client at a faster rate, while also giving the client an efficient and speedy turnaround time. It creates a time-saving effect on many levels.
• Establish a documentation standard. Determining what should be included in notebook documentation will surely differ from lab to lab. When it comes to documentation, with few exceptions, less is not more. Some might consider a lone entry in the equipment logbook to be the extent of necessary documentation regarding the equipment used, claiming that equipment usage data can be retrieved by searching logbooks by the date of analysis. That may be acceptable practice in some laboratories, but a contract laboratory should always focus on how best to serve its client. Would a client want to search every equipment logbook the lab may have in order to find the documentation it’s looking for? Or would the client prefer to be able to look at the laboratory notebook and find all pertinent data there, with cross-references to any equipment logbook also used for the analysis? Keeping the client’s interests in mind will help determine the format of the laboratory notebook documentation. Documenting all equipment used for analysis is good, but adding the calibration date for those instruments is better; adding the next calibration due date is better yet! Similarly, recording reagents and solutions used for the analysis is good, adding the CAS numbers is better, and adding expiration dates and any preparation references is better yet. If the lab records this information initially during an analysis, the client and data reviewer will be able to review the experiment and find the answers to questions that may arise, such as:
“Were fresh, non-expired chemicals used?”
“Was the equipment that analyzed my product in calibration?”
“Were correct instrument parameters used?”
Standardizing a detailed, organized and informative laboratory notebook format serves to give the notebooks within the laboratory a universal and efficient appearance while allowing a reviewer or client to locate data easily in the same place from notebook to notebook.
Keeping track of all chemicals and solvents used and stored in a laboratory can seem like a massive undertaking. There are typically hundreds of dry reagents stored in various locations throughout a laboratory, under different storage conditions. Solvents and acids and bases can fill a multitude of flammable cabinets and under hood exhaust cabinets. It is necessary, however, to immediately remove and dispose of expired chemicals, lest they be unwittingly used. It is also important to know what chemicals and solutions are being stored in the laboratory at any given time for safety purposes. There is an easy and effective way to maintain an accurate and current inventory of all laboratory chemicals and solutions that allows for easy identification of expired reagents and even promotes effective age rotation of chemicals.
• Create a reagent database. Formally enter solvents and reagents into a database as they arrive in the laboratory for use. Document the date received, manufacturer and lot number for each individual item and container. Assign and record the expiration date as required leaving a blank space for later entry of the date when the reagent is physically removed from laboratory inventory. Although this is initially a tedious process, ensure that all reagents present in the laboratory are entered into the database.
• Provide reagents with a unique identification. Establish a system of identifying reagents with unique symbols or numbers for each item and container, incorporating the date received into the identifier. Apply a highly visible label to the outer surface of the reagent bottle, listing the unique identifier, expiration date and a designated space to record the date when it is opened. Once the tedious chore of initially assembling the inventory is completed, the lab will recognize the benefits of having an up-to-the-minute chemical inventory of the entire laboratory with all pertinent manufacturer information, including expiration dates and lot numbers. Recording the unique identifier given to each reagent container can replace recording the lengthy manufacturer and lot number information in laboratory notebooks. If the unique identifier system incorporates the date received, it is easy to keep multiple bottles of a chemical or solvent rotated by age. The oldest regents can be easily identified and then used, before opening a newer bottle.
• Physically remove expired reagents from inventory. Routinely check the reagent database for expired reagents. As reagents expire or are used to completion, they must be removed from laboratory inventory and the date of removal recorded in the database. This must be done to ensure that the database only contains reagents currently stored for use in the laboratory. The database can also be used to check quickly against the material safety data sheet (MSDS) file to ensure that it is up to date.
The reagent database efficiently organizes and maintains a lot of information for a minimal amount of initial effort. Larger laboratories may decide to maintain several individual databases to organize reagents by composition (dry chemicals and solvents) or by toxicity. The database should suit the laboratory’s needs in order to be effective.
Client Organizational Tips
It can sometimes be difficult to interpret what a client expects from a contract laboratory. It is ideal for a laboratory to establish and maintain a conscientious rapport with clients from initial contact onward, to keep in step with them and fulfill their needs. A client’s needs would be better met if the client was as prepared as it expects the laboratory to be when negotiating and engaging a laboratory for services. The following tips can help clients better prepared themselves for working with a contract lab.
• Personally visit the contract laboratory. Clients should take a good look at the facility that might be handling their products. Meeting the people involved with the laboratory and taking time to talk with them provides a great opportunity to begin an interpersonal relationship with the laboratory personnel and to get a “feel” for them. Ask them questions and observe them as they respond. This may be the the best opportunity to ascertain whether or not their facility is right for the project. Check any equipment that might be used for the product and inspect it for cleanliness and maintenance. If the laboratory is qualified and capable, the staff will welcome and respect your inquiries and concerns. This may be the only real chance a laboratory will have to personally interact with the client and demonstrate their qualifications.
• Negotiate with the laboratory manager. Often during the negotiation process, a client or the laboratory may be represented by non-scientific employees from their respective organizations. These representatives may not fully appreciate the critical details that a laboratory must have in order to fulfill a client’s needs. Either party might not be fully aware of the laboratory’s capabilities, costs and turnaround times. They might be under-informed as to what data the laboratory requires in order to perform an analysis. This has the potential to become a distressing situation for all involved. To prevent such problems, the contract laboratory should be represented in all aspects of negotiation by personnel from within the contract laboratory itself. The laboratory manager is the best qualified person to determine a laboratory’s capabilities and to give an accurate estimate of the costs involved and the timeline in which the testing is expected to be completed. This will help enable the laboratory to fulfill client obligations to the client in the quickest, smoothest and most organized manner possible.
• Provide clear, detailed and complete expectations and instructions. Ideally, a client will provide the contract laboratory with detailed instructions describing the analysis to be performed with clear specifications. An adequate quantity of product sample, clearly labeled, with any necessary identification or hazard information should be provided along with product MSDS for safety and waste handling purposes.
• Provide a Project Contact. There should be a client project contact available for questions the contract laboratory might have and any arrangements for returning remaining product sample following the analysis. The contact should be highly knowledgeable about the product and be available for fairly easy and swift contact with the laboratory.
When a contract laboratory is able to receive instructions, updates and responses to questions or concerns from its client, it is able to provide the highest level of quality service. If clients are difficult to reach or slow to respond to laboratory inquiries, the laboratory will not be able to provide quick or efficient results.
Laboratory Personnel Organization
A contract laboratory analyst must be able to perform a wide variety of tasks in a minimal amount of time. Being educated, trained and competent is certainly of major importance, but the ability to perform in an efficient fashion is just as critical. The contract laboratory analyst must be able to keep the laboratory maintained with much order and little time.
• Take full advantage of lull time. Labs shouldn’t permit the luxury of sitting back and taking it easy when workloads are lighter than usual. Staff should take advantage of any extra time to prepare for future work. Everyday routines can also provide small blocks of time to be used for smaller tasks or for larger ones that could be performed in stages. Use the hour in which a sample is sitting in an oven to review databases for upcoming expiration dates approaching and update the laboratory calendar. While waiting for system suitability results, file papers from the accumulating stack on the desktop or set up the pipette washer. Use larger blocks of time to wash glassware requiring specialty cleaning procedures, or to order laboratory supplies.
• Communicate frequently with supervisor or lab manager. Supervisors and managers can provide information about upcoming projects to analysts in order to prepare the laboratory in advance. Potential supplies, equipment and vendors can be located and researched in advance of a project arriving for analysis or even prior to negotiations between the client and laboratory. Analysts are highly suited to aid supervisors and managers in selecting vendors, reviewing client requests or other activities. Analysts can perform more effectively when they are kept informed and can serve to relieve managers of certain duties.
• Don’t wait until the last minute. Never allow the laboratory to run out of critical or commonly used supplies before placing a replacement order. Don’t wait until after a sample is prepared to ensure that any equipment required for analysis is operational. Don’t begin a tedious experiment at the end of the day. Don’t let every piece of glassware in the laboratory get used before washing.
An analyst should keep regular laboratory items in a state of readiness in order to be organized and efficient. Keep glassware and other items clean, without allowing used vessels and expired sample preparations to pile up and clutter bench-tops. Dispose of expired solutions and reagents regularly. Through consistent effort, there should never be an expired solution or reagent in laboratory inventory. Staff must use slow periods to their best advantage. Keep an ongoing “shopping list” of supplies that are used regularly in the laboratory, with corresponding vendor information, prices and part numbers to save time when ordering.
Due to the nature of a contract laboratory, there is always something new to look forward to. New product samples, new clients, new methods of testing and often new instruments are added to the laboratory. The laboratory manager must stay on top of all developments. It’s not easy, but laying down a good groundwork will enable the manager to boost efficiency and organization in the lab.
• Keep analysts informed and prepared. An analyst’s best line of defense is to know what is coming so that he or she can prepare for it. It is an analyst’s worst nightmare to suddenly receive a new sample unexpectedly and then discover that a reagent necessary to perform testing is not immediately available from a supplier and will be on back-order for several weeks. If the analyst had been better informed, he or she would have been able to plan for the analysis and make arrangements to have the required supplies in the lab prior to the arrival of the sample, resulting in the analysis being performed in a timely manner. Lack of preparedness in a contract laboratory does not attract repeat business. Because the laboratory manager is the relay between the client and the laboratory; communication with analysts must be effective in order for the laboratory analyst to be effective as well.
• Become part of the project negotiation process. Typically, the laboratory manager has the most insight as to laboratory costs and capabilities, as well as the scientific experience to extract any necessary information from the client. The lab manager can help to prevent financial losses from underestimating laboratory overhead costs. The manager’s expertise can also serve to help attract clientele to a contract facility if it is properly incorporated into business and sales departments.
• Remain close to the laboratory. Although laboratory managers might maintain office space outside of the lab, they need to have a physical presence within the laboratory. There is probably no reason to “haunt” the analysts while they are working, but frequent, brief visits to the laboratory should become a daily habit. Even a short visual observation of the analysts at work will give the manager a general idea of their performance and provide frequent opportunities to offer advice. Establishing a regular presence in the lab will also demonstrate to the analysts that the manager is available to them. Often, more information is shared and communication is more effective through brief, frequent and spontaneous encounters than in longer scheduled meetings.
The phrase, “organized laboratory,” need not be a misnomer. It is an achievable goal even for a busy contract laboratory. Success in the contract laboratory is a result of integrating many factors and systems together at once and is dependent on everyone involved, even the client. Efficiency and time savings will increase by maintaining a clear flow of communication, combining tasks and using the limited time available to its maximum potential. With persistence, planning, and some initial hard work, any laboratory can be an organized and smoothly operating facility.