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Siegfried Schmitt, PhD, is principal consultant withÂ PAREXEL, Siegfried.Schmitt@parexel.com.
Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.
Q. During a recent audit, we received an observation relating to our incoming goods inspection process in the warehouse. Our current procedure requires us to check for damage and to assure the correct goods are received. We currently do not have a detailed description on how to perform this task, as we find this would be far too complicated to describe. Can you recommend a solution for this?
A. What you describe is often observed during audits. Let us first analyze why this is the case. Warehouse personnel are usually very experienced and therefore know what to look for when goods are delivered. This experience is shared with new staff members, albeit often on an informal and on-the-job basis. This is not to say that these persons do a bad job, but as you learned from your audit, this process has to be described in sufficient detail, and it must be documented.
As there will be many different types of packaging for the wide variety of goods that are delivered to a warehouse, you may find it difficult to provide a detailed enough description in your instructions procedure, without it becoming too complex and unwieldy. There are solutions for this, which are a combination of instructions, check lists, and training materials.
The instructions need to detail what to check, for example:
• Before unloading:
- Correct license plate of the delivery vehicle
- Correct name of delivery company
- Delivery papers complete and correct
- Interior of the delivery vehicle clean, no odors/smells,
dry (no condensation or puddles), and deliveries orderly
stacked (not a jumble)
• During unloading:
- Correct handling of goods
• After unloading:
- Any signs of damage
- Any signs of tampering
- Correct labels
- Correct amounts
- In case of wooden pallets, correct treatment stamps applied.
The above are just typical examples that are often second nature to seasoned staff, which can be detailed on a check list as an attachment to the procedure. Now this still does not provide all the detail your inspectors were looking for. Let us look at the check for the correct license plate of the delivery vehicle. The instruction could be like this:
• The warehouse operative documents the vehicle’s license plate. To do so, the operative must go to the vehicle and record the plate number on the form.
• Confirm that his or her license plate corresponds with the information provided by the shipping company. In case of discrepancy, stop the process and report a deviation.
Now let us take another example: ‘looking for any sign of damage.’ It is difficult to describe in words, what is in reality a visual impression. Therefore, it is best practice to prepare photographs of any kind of damage. These are then annotated and explained. Such a photo library is an excellent training tool; and in fact, this is where this library should be placed.
This training material can be updated each time a new kind of damage is observed. Of course, version control should be maintained. For example, if the operator has to check a carton’s outer package for damage, there may be a superficial cut or tear. The extent of the damage determines acceptability or not. The warehouse operative will document on the check sheet the type of damage and whether this is acceptable or not. The easiest way to do so will be to compare the observed damage against the photo library and document the reference number from that library. In case of doubt, a picture should be taken and appended to the check sheet. This minimizes ambiguity in the process. Following such an approach-which leverages instructions, check sheets, and picture training materials-should provide you with a solution that is easy to follow, well documented, and above all, compliant.
Vol. 31, No. 9
When referring to this article, please cite it as. S. Schmitt, "Checking Incoming Goods," BioPharm International 31 (9) 2018.