SAP Quality management in manufacturing - Food safety and Quality Audits

[Balaramaswamy]

1. Objective 
A food safety and quality audits are a systematic processes for checking of a food manufacturing facility
process systems to ensure that food is manufactured with good quality and safety. Food safety includes
to have the efficiency and the accuracy of the product. cGMP Guidelines (Current Good manufacturing
practices) and GAMP guidelines (Good automation manufacturing practices) helps in maintaining the
FDA regulatory requirements.

2. Food safety and Quality Audits with SAP QM

Food Safety Audits can be categorized into following sections and we can discuss every step and how SAP
QM plays role in the process of documentation.

1. Equipment Audit
2. Process Audit
3. System Audit

Equipment Audits - Equipment Audits include how we validate the Equipment and what are the key
critical points that are to be validated for the food safety of the product. For example, if we Observe a pH
meter, we need to have proper documentation and validation of the pH meter for having the right pH
value to achieve the right quality product. If the pH meter is not calibrated it can lead to producing
defective product and can cause food safety issues.
Metal detector validation is the critical validation which should be documented in any Food safety plan
as metal detector validation plays a key role in identifying any metals and any foreign particles in the
food product.

SAP QM role in the Equipment Audit

SAP QM plays a key role in Equipment Audit and where you can perform the preoperational checks, if
you have plant maintenance you can use different inspections with QM integrations. But if you have SAP
QM and not Plant maintenance, you can create 89 inspections and with inspection points functionality
to have date and time stamp and inspect the Equipment and record the results before doing any
operations on the Equipment to ensure safety and efficacy of the product. Creation of the inspection lots
should be automatic to avoid any manual intervention, you can do it weekly open and closing the lots or
you can do it monthly depends on your business requirement and the frequency.
You can also do a line audit to check if any issues are with the line and record in SAP QM to ensure
everything is good and good to go.

If any issues are found, you can create a Quality notification and send it to the maintenance team or to
the QA managers to address the situation and close the notification loop to avoid the issues during the
operation.
SAP also provides the digital signature functionality by inputting user id and password to comply with 21
CFR PART 11

Process Audit

Every Food manufacturing facility will have different processes and each of them need to be
documented properly. These processes need to be documented step-by-step which includes the R&D
process and the scale up process that was performed in the plant.
Processes include Pre weighing; how much you have to weigh on the scale and the weight needs to be
documented and needs to match with what was defined in the food safety/quality plan.
After the pre weigh process you move to a Blending process, in which you mix all the ingredients in the
right proportions and document at every level including mix speeds and time.
After Blending process, Batch process which includes various steps, in which you make the product and
confirm that all the specifications are met and documented.
Once the Food is manufactured, you move to the packaging process which includes various steps which
includes packing the product and having the code dates printed.

SAP QM role in the Process Audit

SAP QM is a great tool for the process audits for the Quality and operations team. In every process
discussed above we can record the results and document them. In SAP QM we can develop inspection
plans with 03 and 04 inspections, I prefer using 04 inspections for all the processes so that users can be
in the same screen and monitor the process easily. We can segregate the inspection plan operations with
different operational levels. we also have the functionality to create the lot up on the release of the
process order which helps in maintaining one inspection plan and it helps a lot in maintenance of the
master data, you can also set up with inspection points functionality so that you can inspect the lot any
number of times. Based on the business requirements you can have the stock postings set up for the
inspection lots. In the inspection lot, you can check the specifications, inspection methods which can
help in recording the results so that user knows if the product is complying and what standard operating
procedures, he can use to confirm compliance to specification.
For the pre weigh process, you can document the weights, you can also integrate the scales with SAP QM
while recording the results and make sure the weights that are defined the specifications are complying
in what we are recording the actuals and have the digital signature of the QA to ensure right quantities
are in place with the right values are recorded.

In the Blending process inspections, you can take the samples and record the results and make sure the process is intact and without any deviations. If any deviations that are found create Quality Notifications
to be addressed with corrective and preventive action (CAPA).
Like the Blend process, you can also record the results in the Batch process and document the same in
SAP QM and ensure process is intact and compliance with the food safety plan.
After the product is produced, we need to ensure that it is in compliance with all the specifications,
inspections and passed all the metal detection requirements which is extremely critical in the process to
ensure we do not have any foreign objects in the food Product.

System Audit

System audits play a crucial role as we rely on these systems for maintaining our inspec􀆟ons, so we need
to conduct a thorough audit for the system to ensure if meets the GAMP guidelines (Good automation
practices) and complies with FDA guidelines.
During the implementation of SAP QM at various phases we need to ensure the system validation is
completed and audited. After we configure the system, we need to ensure Configuration controls are in
place and documented. Every testing phase needs to be approved and documented to ensure the right
flow of the process is in place. Data loads should be validated before loading to ensure all the data is
intact and in compliance with regulatory requirements.

SAP QM role in the System Audit

SAP QM helps the auditors to have a glance of the recording, QA managers/Auditors can verify the
results of the recordings with date and time stamp, with process orders, batches, and inspection lots tied
to the Quality notifications that got created for any deviations and that they are properly closed and
documented before releasing the product. Data that is available in the SAP QM can also be used to plot
the graphs and check if there is any deviations or corrections that can be done before releasing the
product. You can also monitor the product if it is on hold and check why the product is on hold and
ensure all the issues are resolved or if any defects exist for the product. Integration with other SAP
Modules/ Systems is the beauty of SAP QM, 21 CFR part 11 helps in safeguarding the data by using the
digital signatures.

3 Conclusion

SAP QM is powerful tool and can be used extensively in maintaining the quality and safety of the
product. SAP FIORI helps the users to have more user-friendly screens and can be installed in
Tablets/IPAD. Super users can easily maintain the master data and can be easily rolled out. Users can
harmonize their data and have consistency and comply with the FDA regulations.

4 References
GAMP guidelines for 21CFR PART11