Employee not following Purchasing Process

T

texkb

#1
We recently had an employee who was trained on the purchasing process not follow the purchasing process. Our purchasing process requires that an employee fill out a request form with a detailed description or attached quote of what they want to purchase. The form also calls for the verification that the supplier they wish to purchase the goods from is on the approved supplier list. Once the form is completed the form is given to management for their review and sign off.

In this case the employee did not follow any of the steps in the process he simply just purchased the good. Lucky enough for us the supplier that he purchased the goods from was actually an approved supplier.

My question is what type of paperwork needs to be completed on this for ISO 13485? Does this just require an email to the employee reminding them of the process or does their need to be a CAPA completed for this?

Thanks
 
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qusys

Trusted Information Resource
#2
We recently had an employee who was trained on the purchasing process not follow the purchasing process. Our purchasing process requires that an employee fill out a request form with a detailed description or attached quote of what they want to purchase. The form also calls for the verification that the supplier they wish to purchase the goods from is on the approved supplier list. Once the form is completed the form is given to management for their review and sign off.

In this case the employee did not follow any of the steps in the process he simply just purchased the good. Lucky enough for us the supplier that he purchased the goods from was actually an approved supplier.

My question is what type of paperwork needs to be completed on this for ISO 13485? Does this just require an email to the employee reminding them of the process or does their need to be a CAPA completed for this?

Thanks
Did you also evaluate the effectiveness of the training in this case, considering that he did not follow the procedure?
What was the root cause for this issue?
As suggestion you could check if the process in place is "mistake proof" or not, and just in case consider to revisit if the risk is high.
hope this helps:bigwave:
 
#3
I think it might be a lot more complicated than that. Something I learned many, many years ago is that lack of performance comes from two factors; deficiency in knowledge, or deficiency in execution. The question should be; “Why did the person not follow the procedure?” If it is knowledge, then it indicates one thing, but execution indicates something much deeper. In many cases, where procedures are not followed, I have found there are barriers that restrict performance. Perhaps the forms are too complex, or not available, or maybe the approval time is too long (real or imagined). I would recommend you look at the process and ask what barriers are in place that give folks excuses to bypass expectations.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi,

The answers given above are good references on how to handle the investigation (to identify the root cause) and CAPA, so they hint that these should take place. To give a direct answer to your question, my opinion is that the case should be formally captured as a Non-Conformance (NC) and the procedure(s) your company has for handling these should be closely followed. I do assume NC issuing and handling procedures are in place and include some sort of investigation, root cause identification and CAPA implementation (including effectiveness verification).

One more thing - from my experience, many times the plain employee perspective entails that not following *any* defined procedure is easier than following the prescribed ones. Therefore, even if the procedures are quite user-friendly, not following procedures is many times a matter of motivation and/or attitude. Addressing these requires both looking into improving attitudes and motivation to follow procedures (which could be very difficult at times) and placing safeguards to ensure the process can't move forward so easily unless the procedure is followed (which could sometimes be tricky as well).

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#5
Our purchasing process requires that an employee fill out a request form with a detailed description or attached quote of what they want to purchase. The form also calls for the verification that the supplier they wish to purchase the goods from is on the approved supplier list. Once the form is completed the form is given to management for their review and sign off.
In this case the employee did not follow any of the steps in the process he simply just purchased the good.
Is the employee a purchasing function personnel ?
If he is, then he perhaps has seen the approved supplier list and went about action as the procedure going upto management for signoff etc., seemed cumbersome for him.
If he is an other department personnel then you have a big task of correcting the company purchasing process.
Please do clarify, as purchase department does actions based on a specific department requestor for goods or services.
 

harry

Super Moderator
#6
....................... In this case the employee did not follow any of the steps in the process he simply just purchased the good. .....................
You can simply refuse to pay!

Honestly, this is an indication that something is seriously wrong with your organization. It shouldn't happen unless your organization does not have basic financial control or check and balance.
 

kuyakut

Involved In Discussions
#7
I'm not really sure of your purchasing procedure. But difinitely there are some clauses in your procedure that for this specific amount of pruchase no need for department head to sign. Because it will be trouble some for a purchaser even below 100 dollars to get the signature of top management. As for approved supplier list , this list should come from purchasing because they are the one conductinmg an assessment. It may seen as a by pass on the purchasing process flow if any of the above clauses is not in your purchasing procedure.

Kuyakut
 
P

phloQS

#8
How can a single person simlpy order goods? Can he sign an order for your company? Which kind of goods did he order, production goods or just something for the office like paper with no influence on product quality? You can set up strict rules who is allowed to order in your company. This can be comunicated with your suppliers so just these persons can order.
This could be the corrective action in your case. I would suggest that you do a complete CAPA process in the way your copany has defined it.

Regards,
phloQS
 

RoxaneB

Super Moderator
Super Moderator
#9
Let's face it, Purchasing is a process that not everyone will see the value in. Having spent some time in the Procurement world, trying to help standardize their processes and improve their performance, it is important to recognize that there are several "types" of purchases.

Normal - This is the type of purchase that follows the purchasing process and all paperwork is completed accordingly. Lead time and requester need are aligned.

Urgent - This purchase type is needed because there is insuffient lead time to address the requester's need, but there is no impact to safety or production (i.e., shut down). Paperwork may follow later, however, there will be a push to expedite the item, ensuring it will arrive on time or when needed.

Emergency -This purchase type is needed now. Paperwork will follow later. The item is needed ASAP to address a possible safety, environmental or production(i.e., shut down) issue.

Then there is maverick spend. These are the purchases that do not adhere to the purchasing process and the three types above. These are also the purchases you want to focus on.

As others have said, knowing WHY the user has deviated from the process is important. However, I also recommend ensuring that there is some flexibility within your purchasing process.
 
D

Dudes

#10
All very good points made above.

Sometimes the worker didn't follow the process because he didn't feel it necessary. This is why, when I train people on new SOP/processes/... I always make a point of explaining them WHY it is important that the procedures are followed. Procedures are not here to make their work harder, but for a very specific reason (ensure safety, reliability, compliance, ...) If you can't find a good reason while explaining the procedure, then you should maybe rethink it. It is really needed?

Procedures should be built in such a way that the worker can understand why it is so important that they are followed and that the additional work created is bearable.
 
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