Recipes, potency and batch records signed by two people
Mark a bill of materials as a recipe with its expected yield and batch steps. Each batch gets a batch record, filled as the work is done and verified by a second person. The order closes only when the record is complete. The yield and process loss are kept.
PLANSScale only
The problem it solves
- Batch records are filled on paper at the end of the shift and signed later.
- A reading outside its limit is noticed only at audit time.
- An active ingredient's strength varies from lot to lot, and the quantity is adjusted by hand.
- Yield losses come to light at month end.
How it works
- On the bill of materials, tick Recipe, set the Expected Yield (%) and add the Batch Steps. Each step has the instruction and what is recorded (such as temperature) with target, min, max and unit. It also says whether a second person signs off.
- For a component whose strength varies, tick Adjust for Potency on its BOM line; set the item's standard potency and each lot's measured potency.
- Confirm the production order: its Batch Record tab gets the recipe's steps. Press Adjust for Potency to scale those components to the lots reserved.
- Record each step as it is done: entering a value or a note marks it done with who and when. A value outside its limits is marked.
- A second person presses Verify on steps that need a sign-off. Mark the order done: it is refused while a step is not done or a sign-off is missing. Print the Batch Record PDF.
Everything it does
Recipe
- Recipe on the bill of materials, Expected Yield (%) 100 to start with
- Batch steps: Instruction, Record, Target, Min, Max, Unit, Second Person Signs Off
- Adjust for Potency on a BOM line; Standard Potency (%) on the item, 100 to start with; Potency (%) on each lot
Batch record
- Laid out from the recipe when the production order is confirmed
- Per step: Value, Note, Done, Done By, Done At, Sign-off Needed, Verified By, Verified At, Within Limits
- Verify needs the step recorded first, and by someone other than who recorded it
- A value outside its limits shows as not within limits; it does not block
Potency
- New quantity = planned quantity times standard potency over the lot's potency (average of the lots reserved)
- The order's chatter lists each adjusted component, its new quantity and the lot potency
Closing the batch
- Refused while a step is not done, naming the steps
- Refused while a sign-off is missing, naming the steps
- Yield Achieved (%) and Process Loss kept on the order when it is done
- Batch Record PDF from the production order: every step, the readings, who recorded and who verified
Who uses it
Production ManagerWrites recipes with their steps, limits and sign-offs.
SupervisorRecords each step of the batch as it is done.
Quality or a second supervisorVerifies the steps that need a second person.
Quality ManagerReads yields and batch records; decides on failed lots in quality control.
Where you use it
- Web: the bill of materials (Recipe, Batch Steps tab) and the production order (Batch Record tab, Adjust for Potency, the Batch Record print)
- Not on the shop floor terminal or in the SmartMy Manufacturing app
What you control
Settings
- Expected Yield: 100 % to start with, per recipe
- Standard Potency: 100 % to start with, per item
- Second Person Signs Off: per step, off to start with
Questions
Can the same person record and verify a step?
No. Verify is refused for the person who recorded the step; a second user must press it.Is this an electronic signature for regulators?
No. Each step records the user who recorded it and the user who verified it, with the time. It is not a password-confirmed electronic signature, and it has not been validated for any regulation.Can a batch be closed with a reading outside its limit?
Yes. The step is marked not within limits but does not block. Hold the lot in quality control and decide it through a non-conformance.How is potency applied?
Press Adjust for Potency on the order: components marked for it are scaled by standard potency over the measured potency of the lots reserved.Related features
PRODUCTION AND JOB WORKBills of materials, production orders and work ordersKeep each item's bill of materials with its components and the steps on your machines. A production order reserves the material, lays out the work orders step by step and puts the finished goods into stock at cost.PLANNING, QUALITY AND COSTQuality checks with sampling (AQL), held lots and non-conformanceCheck material as it comes in, each step on the floor, the finished product and goods going out. Each check has a sheet and a sample worked out from the lot. A failed check holds the lot, raises a non-conformance whose decision is approved, and a Rework decision makes the rework order.PLANNING, QUALITY AND COSTAs-built record of a lotPrint a record of exactly how a lot or serial number was made. It has the order and bill of materials, each component with its lot, and each step with its machine and time. It also has the operators, the rejects and the quality checks with their values.PLANNING, QUALITY AND COSTRecall list: forward to customers, back to suppliersPick a lot or serial number and see, in one list, every lot made from it and every customer who received them. Or go backwards: every component lot and supplier that went into it. Export the list and call the right customers.PLANNING, QUALITY AND COSTSupplier quality and certificates of analysisPrint a certificate of analysis for any lot from the checks it passed, with each test, its limits and the measured result. See which suppliers pass and fail your incoming checks, item by item.
See your shop floor on it.
Tell us what you make, how many machines and people you run, and how production is recorded today. We will set up a line with you and run a job on the terminal.