Title: 1.1 Engineering Design Journal
Course: ATEP - Biotechnology Module B > Section: Course Safety and Training

1.1.1 Design Journal

Documentation in a lab notebook is an essential skill for any biotechnician. The Food and Drug Administration's (FDA) handbook states, "If it isn't written down, it wasn't done." Documentation details vary from lab to lab but it is essential for one or more of the following:

- to record what an individual has done and observed
- to establish ownership for patent purposes and other legal uses
- to establish criteria used to evaluate a finished product or the process to make it
- to trace the manufacture of a product
- to create a contract between a company and consumers and/or between a company and regulatory agencies
- to prove that a procedure was done correctly
- to adhere to, evaluate, and develop standard operating procedures (SOP)

1.1.2 Engineering Design Journal

Good lab work is worthless without documentation, and careful documentation can turn an erroneous result or a failed procedure into a valuable learning experience by providing essential details needed for trouble-shooting. Furthermore, in industry, laboratory notebooks are legal documents. They are used to determine patent rights, product quality, liability, and to verify the accuracy of information. Notebooks are treated as if they might be used in a court of law at any time, and you can, in fact, be called upon for questioning about your notebook in court.

An important part of this documentation process is to record what equipment and materials were used, and to show that the equipment and materials were validated and used in the correct manner. Companies must be able to produce documentation for audits by government regulatory agencies to prove that Good Manufacturing Practices (GMPs) were followed. If the material in the notebooks was not entered legibly, or information is missing, companies may be fined or the company may be held liable for damages in a product lawsuit. In research and development labs, the same careful documentation is necessary to establish rights to valuable patents. The value of a well-kept notebook cannot be overstated.

1.1.3 Design Journal Guidelines

Each team will maintain a design journal from which the final presentation for this course will be derived.

General rules for writing good journals are:

- Write all parts of your lab notes and observations in ink. Writing with pencil is forbidden in the lab. If you make an error, draw a single line through it and enter your correction in clear and legible writing. If you discard data for any reason, you must justify your decision to do so immediately and in writing.
- Write legibly. Remember, supervisors, and possibly lawyers, will be reading your notebook. If they cannot read your writing, your work is essentially nonexistent, or they can easily misinterpret an important detail about your work.
- If you tape materials such as a graph, a manufacturer’s specification sheet, or instrument readout into your notebook or onto a form, tape all four sides. Then write "NWUI" ("No writing under insert") on the tape, your initials, and the date.
- Keep your records factual, concise, clear and complete in all aspects.

Below is an example of an excellent journal entry

More specific rules can be found  in the document titled Engineering Design Journal Guidelines to set up your own notebook.

1.1.4 Evaluating Your Team's Journal

Design Journal Rubric

In Module A, you studied and applied the Informed Design Process in the Technology Park to produce and isolate insulin. Review this process below.

In Module B, you will perform this same process and capture the design process in the Engineering Design Journal. The Design Journal Rubric seen in the image below will be used to score your team's journal entries and end of course presentation. Use this rubric for guidance on what should be recorded in your journal.

Design Journal Check

Your instructor will check your journal several times throughout the course using the rubric below. Be sure your journal notebook is always up-to-date and follows all journal guidelines.

1.1.5 Your Engineering Notebook

Using the Notebook Guidelines, set up your team's notebook. By the end of this activity, your notebook should include:

1. Book Cover
2. Table of Contents
3. Engineering Journal Guidelines (taped in)
4. Engineering Design Journal Rubric (taped in)
5. Design Journal Check (taped in)
6. Your first entry of what you accomplished today