Certificate of Analysis – Incoming Certificate
This document will show you how to manage and store the quality certificate from the vendor. Certificate of Analysis plays an important role in the Pharmaceutical industry. COA ensures the GxP practices have been followed during the Production of the goods. In this scenario of procurement of goods from the Vendor, the vendor is expected to provide the Quality certificate along with goods sent with it. if the vendor fails to provide the certificate, the system has been configured in a way that it will allow the goods to be received and perform an incoming inspection. At the time of usage decision if the Quality certificate is not attached to the received goods then the system won’t allow stock posting to be done. The system also has been configured that the incoming Quality Certificate is attached along with the purchase order item and stored in the Content Repository and viewed whenever required.
Note: Assuming that the Configuration from Procurement side is already present and 01 inspection type is assigned to material in the material master.
The following configuration needs to be done before goods can be received with COA.
- Define the Control key for procurement – the control key is used to define the Document Control, Source inspection Control, Checks to be performed during the procurement,
Here in this control key,
As this document is illustrating the COA Scenario, the certificate required checkbox will ensure that the certificate is provided along with the delivered goods and the Release Required checkbox ensure that the supplier relation must be released before any procurement takes please i.t it will check the Quality info Record, in that it will check whether the vendor is blocked or not. and the Release Date for the Vendor.
2.Define Certificate Type:
The Certificate type specifies the further processing, whether you require certificate per GR item, Cert. per PO Item,
The checkbox Certificate check required will show a yes or no in the purchase Order data during the MIGO( Post goods movement ), to specify whether the vendor has provided the certificate or not.
There is a provision of sending a reminder & escalation to the Vendor if they have failed to provide the certificate along with the goods sent. Once the reminder date has been reached using QC55 the reminder mail will be triggered to the vendor(the standard function module QM_CERT_REMIND will be triggered ).
Control Without Certif with the config shown in the above screenshot will ensure that even if the Certificate is not provided at the time of GR, then also the further processing can be carried out but the usage decision can be halted till the certificate status is updated as stored and inspection in QC51 transaction.
3. Define content Repositories
you need to define the Content Repository, a content repository is a place the incoming Quality certificate will be stored.
NOTE: make sure that the Content repository name is 2 characters long only
4. define Link for object repository
The link for content repository needs to be maintained, the created content repository is assigned to the business object and document type as shown in the below screenshot. The object type and the Business object help is provided by the SAP in the Documentation.
5. Certificate check at the time of GR and status reflection in the inspection lot and Certificate
Assuming that the PO is created and has been released, so during the goods movement, the Certificate Check required indicator will be shown in the purchase order data.
The certificate receipt yes or no status can be seen reflected in the certificate receipt using QC51 transaction.
In this scenario, as we can see that the vendor has failed to provide a certificate along with the goods sent, you can see the same getting reflected in the certificate status.
you can still proceed with the result recording but the usage decision cannot be done as you can see from the inspection lot status that CTCM ( certificate confirmation missing is still there
if you try to do usage decision the following pop-up will be thrown saying that the certificate confirmation is missing, also the same can be seen from the inspection lot status CTCM( Certificate Confirmation Missing )
6. Attaching the Quality Certificate and Archiving it
go to QC52 transaction, enter the purchase order number and the item number., the following certificate will be reflected.
open the certificate then go to archive Original path as shown in the below screenshot.
Specify the file path of the PDF version of the Certificate and document type as shown in the below screenshot and then click on Transfer. After Clicking on transfer the Document will be transferred to the Content management Repository which we have maintained in the configuration
Update the certificate status manually after attaching the incoming quality certificate from the vendor in the same transaction QC52.
To view the attached certificate against the purchase order item, go to the path Edit > object Links
“OAAD” transaction and click on technical search in the Documents Box and then enter the Business object & document type, execute it and then a pop-up will come for the certificate number. Enter the certificate number and view the document.
After the status of the Quality, Certificate has been updated, the status of the inspection lot can be seen updated with CROK ( certificate received OK )
you can now further proceed with the processing of the inspection lot with usage decision without error.
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I hope this document will be helpful. The additional configuration can be done as per the requirement of the Quality certificate from the vendor. This process helps in making the usage decision whether the received product/material can be kept or sent back to the vendor if the Quality requirement is not as stated.