Must have quality control features for process manufacturing ERPs

Today’s manufacturing disciplines are both complex and largely quality driven. These assertions are particularly accurate when applied to ERP platforms, and more importantly, those that relate to systems involving quality control (QC) processes.

Although one may believe that ERP systems should ‘always’ suggest QC processes as part of a selection evolution, as a practical matter, quality capabilities typically differ in utility from brand to brand; usually based on operational scale and/or price. Consequently, we thought we’d discuss various ERP QC ‘must haves’, and what they’re likely to mean for the average-sized process manufacturer.        

Why is quality control important for process manufacturers?

Before we get to the heart of the matter, it should be noted that there is a significant difference between ERP for discrete manufacturing versus process manufacturing, since the two types utilize dissimilar levels of quality management. Regardless, however, each production type creates finished goods as a final business goal, after first merging various sub-elements.

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However, where the engagement of ERP-driven process manufacturing involves active quality validation throughout a particular production chain; discrete manufacturing usually doesn’t, since these manufacturers typically purchase sub-components on the basis of baseline quality, previously validated by one or more third-party supply-chain providers. This is the reason that process-based manufacturing is sometimes referred to as ‘recipe-making’, rather than discrete producers who simply assemble lists of sub-components, and why the former evolution represents a much more daunting QC challenge.

For example, pharmaceutical manufacturing requires constant quality monitoring throughout the manufacturing chain, since the product evolution involves various chemical, and/or synthetic elements that demand attention to shelf-life, or other counter-indicative substances. If a process step is missed or mis-qualified, an entire batch can be lost, triggering the loss of thousands of dollars, or worse, sick patients who rely on whatever product may be required.

Key quality control features your ERP should include

1. Confirm that the ERP QC system is able to deliver procedural instructions, track events, measure them properly, then archive related results - as an old quality saying goes; “if it's not written down, the event never took place." Consequently, and in the case of ERP quality control for process manufacturing specifically, an ability to define and account for all steps from the delivery of raw materials, to finished goods is a critical capability.

2. Ensure that the enterprise quality management system is able to define and apply an active process priority method – this suggestion particularly applies to flow-monitored substrates, elements, and compounds typically used during the creation of pharma-based products. This requirement will also serve as a direct support mechanism in the event that regulatory or policy-based investigative is necessary after the fact.

3. Ensure that the system is capable of delivering active rules/policy enforcement – today’s process manufacturing, and its necessary ERP quality management modules, must be compliant, and responsive to a host of applied regulatory, state, national, and/or international standards. This requirement must apply throughout the creation and production of any ‘recipe’ that may ultimately be sold to the public.  

Obviously, these three suggestions are only a small sample of the type of requirements necessary to employ a proper ERP QC system, but you should get the point pretty quickly.