Using paper for your batch records has advantages. Paper acts as a bookmark for a process or a physical baton of responsibility. Paper is easy, it’s well accepted, and by sticking with paper batch records you won’t have to deal with any CFR 21 Part 11 electronic signature nuances.
Plus, paper is “cheap,” right?
Some estimate that the actual cost of paper is about $3.75 USD per pound when you include costs of printer maintenance, toner, and storage. Depending on where you live, that’s comparable to the cost of a pound of lean ground beef.
The truth is, analyzing the cost this way is insufficient.
What are the real costs of paper processes? And how can you tell when it’s the right time to adopt an electronic batch record solution?
Here are the seven signs you may be ready to move past using paper and begin manufacturing using electronic batch records. If three or more of the following apply to you, it may be cost effective for your business adopt a manufacturing execution system powered by electronic batch records.
- Missing Manufacturing Data. It is not uncommon that only 3 out of 10 paper batch records are completed without errors. The trouble with paper batch records is that often the errors in the production record are discovered after the fact. The more time that passes between occurrence and when the error is noticed, the costlier the missing data becomes.
- Production Operations is a “Black Box.” Some manufacturing processes may take days or even weeks to complete a batch. The frustration for operations management is that with a paper record all they know is when the record was issued and when it has been completed. This lack of visibility into the manufacturing process, due to poor access of data, usually has a negative impact on training when the complete process remains unseen.
Consider how much time you spend digging through paper to get a periodic “feel” for the state of your operations. If you want to get rid of the black box and understand where you are in the process, then you may benefit from a paperless, real-time solution.
- Lack of Automated Controls. You want to pull data straight off the equipment and remove simple errors. The truth is, humans are good at some things; computers are good at other things. You are trying to find the optimal balance between both to get the best out of your workforce.
- Slow Data is Giving You a Headache. Slow data forces operations into decision making that is reaction-based rather than strategic-based. If under purchasing is a problem due to unrelieved inventory, or over purchasing is a problem because you want to avoid under purchasing—the large WIP, and quarantine inventory is costing you tens of thousands, especially for manufacturers striving to establish lean operations. The solution with paper is to implement excessive secondary verification and manual reviews. It seems, however, that despite double checking, errors are still getting through.
Is this lot expired?
Has this lot of material or sub-assembly been released?
Has this previously released lot of material been quarantined and (attempted to be) removed from the floor?
Has this serial number already been consumed?
If you find yourself struggling to answer these questions, slow data is definitely giving you a headache.
- Cost of Operations. What is your current burn rate in salary paid against work inefficiencies directly generated from paper processes? Manually entering data, the workflow of chasing down errors when missing or out-of-spec information is discovered, double (or even triple) data entry, using spreadsheets on a shared drive as a makeshift database. For companies that are rapidly growing manual processes such as these are not scalable.
- Quality is seen as a Bottleneck. Paper often results in multiple manual reviews, several during production, and then again when they are bundled as a completed production record. (It takes HOW long to review a batch record?) Operations disengages from product quality, and Quality has an increased pressure to “Be faster.” If Quality reviews are a bottleneck, you have likely outgrown paper production records.
- You’re ready to Start SPC and Trending Optimization. Have you caught yourself looking for ways to identify critical manufacturing trends? Which vendors are over or under filling your raw materials? Which equipment seems to be the bottleneck and how often is the night shift outperforming the day shift?
Questions like these can be answered with the data you are already generating. Paper adds extra cost in the time required to collect, digitize, and analyze the data. By the time you have actionable insight hopefully it is still relevant in your fast-moving business