The purpose of this project was to explore writing for a new audience. Writing assignments are usually directed towards the professor teaching the course, but this time assignment was directed towards our previous co-op employer. We used a method of analysis called activity theory, which analyzes the interactions between different components of a group of people. Drawing on my time working there, I analyzed the various methods of communication used and drew conclusions to their effectiveness, as well as pointing out methods where communication was hindered rather than helped.
The Writing Genres of Process Developement at Acorda
After each bout of toxicological production, the Process and Formulation Department at Acorda Therapeutics would lose a day just to fix mistakes. During the six months I was on co-op, we wasted nearly a week of company time and money because of these errors. While the immediate reason for why this happened is obvious to those involved, the underlying cause is harder to see. In order to pinpoint its origin, the Process and Formulation Department is analyzed through the lens of activity theory.
Activity theory is a form of system analysis that models the components of a system and examines the relationships between each component. Activity theory is applied to activity systems: an ongoing community of interacting people sharing a set of tools with a common goal (Kain and Wardle 2012). The ways in which Process and Formulations succeeds will be analyzed with how it fulfills a variety of Activity Theory principles, through their successful internal communication through text messaging and emails. The ways that failures occur shall be analyzed by exploring the frequent issues when utilizing laboratory notebooks and batch records, two genres of documentation overseen by the Quality Assurance Department.
An activity system with has six characteristics. The system must be ongoing, meaning it has existed before the analysis and will continue to exist; object-oriented with a long-term goal shared by its constituents; historically conditioned, with its current status being a result of its history; interrelated, where a change in one part affects others; accomplishing its goals through the use of tools; and, finally, a system is defined by its human interactions (Kain and Wardle 2012). By having people interact, the system benefits by allowing a multitude of roles, traditions, and viewpoints. These differences and interactions within the activity system result in contradictions. These aren’t necessarily arguments or problems, but tensions regarding the current state of the system. This culminates in the dynamic nature of systems: activity systems can and will change in order to relieve these contradictions, resulting in a more efficient and productive community (Engeström 2001).
Process and Formulations
The goal of Acorda Therapeutics is to “develop therapies that restore function and improve the lives of people with neurological disorders” (Acorda Therapeutics n.d.). The therapy we work on is creating effective, fast-acting inhalable forms of medicines. Analysis began by modeling the department as an activity system, shown in Figure 1. The bottom row of the triangle form the social basis of the system (Kain and Wardle 4). The rules are the explicit and implicit guidelines that members have to follow. The community is the organization the system belongs to, helping define the object and goal (Kain and Wardle 2012). The division of labor is the way the tasks are broken up amongst employees to achieve the object. All of these rely on tools to complete the task. While tools encompass the physical machinery used to make the medicine, they also include the modes of communication.
We use a variety of communication methods within the department. The fastest is text messaging. Some examples from my time at Acorda include “Hey would you mind sending over the ACI data when you get back?” (Robert Kuhn, personal communication, August 25, 2016), “We’re good to spray” (Robert Kuhn, personal communication, November 4, 2016), and “The water coming out of the heat exchangers is a very reassuring brown. And by reassuring I mean not that good.” (Jakub Konkol, personal communication, September 14, 2016) These examples show that the messages are brief, to the point, and informal. This is one fundamental aspect of the genre: a level of trust and intimacy (since you have their personal cell phone number) allowing the genre to also be an outlet for humor. Another aspect is that a text message is sent as a result of urgency and temporality. After a day or even an hour, the text message no longer holds relevance. The ephemeral nature of the text results from a mutually understood frame of reference. When it is sent, both parties know what the text message refers, even when the subject is not explicitly stated. However, as the parties forget the context over time, the message loses meaning. This is part of the genre’s purpose: to exist as a momentary conduit of knowledge.
For less urgent messages that require permanency and extra functionality, the department utilized emails. There is an understanding that employees are not always able to check their mailbox, so sending an email has the caveat of knowing they might not see it instantly. Additionally, an email needs to embed context within the message, since the receiving parties aren’t always on the same page. However, by requiring the message to have context, the genre makes emails remain relevant. Additionally, emails are more versatile than text messages. It is possible to send files from one person to another. It is also not uncommon to string together multiple ideas or thoughts in an email, something that is unconventional in text messages where a single message normally encompasses a one idea. The rules of emails are simple, even though not explicitly stated, as employees quickly receive examples from their more well-versed colleagues.
The success of communication within the department can be attributed to each genre having a purpose within the system, and their rules being easy to identify. We quickly learn when it is appropriate to text a coworker or email them, decreasing confusion and frustration. By adhering to the genre conventions, coworkers will know what to expect when they receive a message and put themselves in the right frame of mind to analyze it. Some deviation is tolerated per situation, but by restricting the use of a genre to the original purpose creates an effective group. By having simple rules that were easy to understand without being explicitly told, the communication process was seamless between coworkers. However, the rules in the other genres were not so easy to grasp.
There are two genres that you work with in the laboratory: the laboratory notebook and the batch record. The laboratory notebook is a logbook in which a scientist or engineer writes data, observations, purpose, and procedure for experiments. The primary purpose of the genre is to create an archive of experiments future researchers can examine and use to guide their experiments. The other purpose is to leave accountability. Every page has to be signed by three people: the person running the experiment, a coworker to verify that the information on the page is true, and finally by a legal witness that verifies the document was properly signed.
Laboratory notebooks are legal documents with a set of rules governing them. The issue is that the primary users of notebooks in Process and Formulation Development were new employees, all of whom did not have knowledge of these rules. Oftentimes they were only stated after a bad habit was formed. One example is pasting figures into the notebook, where you initial and date half on the figure and half on the page. This way if it falls out, it will be obvious the page is missing something. What we were never told is the notebook number and page number must also be on the figure itself. When I found out, the hundreds of figures made had to be filled in. This time could have been saved had I known of this rule. Another time loss is handing the notebook to Quality Assurance department for validation. Emails had to be exchanged to find out who had it last, whether we could get it or not, who was using it and so on. Its purpose as an archive was arguable since access was neither reliable nor fast. At one point, we filled a lab notebook and handed it off to Quality Assurance, but then found we needed it again to get access to data for a presentation. Trying to get the notebook back from Quality Assurance took several weeks before it was found and returned. Similar issues plagued the use of batch records.
The genre of batch records had a more focused role than lab notebooks. These are step-by-step instructions for the production of the inhalable medicine. Each step had two boxes for signatures: one for the person who completed the step and another for someone to verify the step was completed. Some steps had spaces to write down other information. This document was only used in the manufacture of medicine, making accountability fundamental. The company needed these to show the medicine was created to specification.
Similar to lab notebooks, batch records follow rules that were never made clear to us. One example of a failure was with a test performed on the medicine. Three trials are run in an aerodynamics test, with the sheet in the record only providing space for three tests. Unfortunately, sometimes the test is invalidated. One time the test was incorrectly performed, so a member Quality Assurance told us to cross out the values and redo that trial. At a later date, the mistake was repeated. Remembering what was said last time, the values were crossed out and the trial repeated. A few days later we were told by a member of Quality Assurance we cannot rerun failed trails, rather write an explanation why this test failed. The difference between the answers given made trusting either source difficult. Another series of tests for particle size required five successful trials. The machine used for this test is finicky, where sometimes thirty trials had to be run before finally get five trials within specification. As instructed, we took the five valid trials and added them to the batch record. Two weeks later, Quality Assurance tells us we need each trial, not just the passing ones. Fixing this mistake took two days by itself. The last significant misunderstanding of rules dealt with error correction. Whenever an error is made, it must be crossed out, initialed, and dated with a description of the error written. The only example given of a valid description is “EE,” or entry error. After signing all of our errors with “EE,” Quality Assurance told us to be more specific since technically all errors are “EE”s. However, they did not offer us any more information as to what is acceptable. The issue remained unresolved.
Communication within the department was successful. Everyone understood the purpose of each genre and the rules regarding them, resulting in a team that worked well together. The problems arose when dealing with Quality Assurance where they assume we know the rules for writing according to their style. Whenever they tried to correct us, no explanation was given so it may be followed, simply that this is the correct way. Additionally, different people gave different answers. This resulted in friction between the departments and lost time. The best solution would be to create a meeting where Quality Assurance meets with Process Formulation and Development and teaches us the rules of writing in laboratory notebooks and batch records, along with time to answer questions and clarify. Having a meeting will answer the most common questions for using these genres and get everyone comfortable with core ideas. Next, they should provide a detailed reference guide that will answer less common questions. Having the rules physically written down will also decrease ambiguity. Finally, Quality Assurance should assign someone as the trusted authority who can advise fringe cases and clarifications. This way, no matter the circumstance, the rules can be followed. By following the rules, company time will be saved.
Acorda Therapeutics. (n.d.) About Acorda. Retrieved from https://www.acorda.com/about
Engestrom, Y. (2001). Expansive learning at work: Toward an activity theoretical reconceptualization. Journal of Education and Work, 14(1), 133-156. DOI 10.1080/136390800200287
Kain, D. & Wardle, E. (2012). Activity theory: An introduction for the writing classroom. Retrieved from http://www.academia.edu/493321/Activity_Theory_An_Introduction_for_the_Writing_ Classroom