Your documented QMS is important, but is everyone still following their procedures properly? Processes can be improved continually, or they can degrade by being rushed, a little careless, or coming up with a shortcut that might or might not work but isn’t according to the process. How do we deal with these variances?
Innovative companies have a culture of improvement, which is not only vital in today’s economy, but is a foundational component of every ISO management system. Then it takes a structured method to ensure ongoing review of processes, or these forward-thinking groups are at risk of having their process control documents left behind during process creep. Sooner or later we all have to train a new person or have to pick up a task that we do infrequently. That’s when an up-to-date process document is critical – we’ve found that true in our own firm! The risk of having a document that got left behind during “process creep” is two fold: 1) inevitably some folks are still following the old method while others are doing it the new way, and 2) while the changes work well for the initiating department, they risk creating challenges for other departments affected by their decisions.
Addressing Process Creep At a strategic level, having regular multi-disciplinary leadership team meetings, that include leads from QA, sales, purchasing, engineering, production, QC and shipping, is critical. This kind of collaboration raises the entire team to understand risks, strengths, and potential changes as they are planned, and allows impacted groups to raise questions and risks that another team may not have considered. Similarly, document review teams should include representatives from all affected departments, to identify missing information needed to meet product and performance goals.
Once a change has been implemented, process-based audits (which review all the documents related to a department or function) allow the auditor to verify that decision trees and escalation criteria are accurately described in all documents; AND that information exchanged between departments retains all critical information to ensure consistent outputs and meaningful metrics.
When Creep Happens…Examples of cross-department impacts:
Receiving has access to the ERP that indicates inspection levels for incoming goods. If QC doesn’t have access to the same data, they may not know when an inspection is routine, or when it’s become high risk and therefore requires a higher sample size.
If final inspection occurs in two departments with different tools, and with different calibration frequencies, the risk is that some tools can go out of calibration.
When Engineering moves from internal prototype testing, to placing the first unit into production, the process validation criteria should have changed from variable monitoring of results to fixed accept/reject levels to ensure consistency of product output.
When management review is looking at performance metrics by department, but data for the same activity performed in different locations is co-mingled, efficiencies and delays are not visible
Process notes don’t get transferred to the next revision, so without a printed/stamped list of criteria to ensure consistency, process engineers may miss recording the key item to solve a dilemma when troubleshooting.
Vendor approval is a list of approved suppliers, with no written record of primary and secondary sources to balance ongoing supply chain delays, so a backup or new purchaser has no accurate information on lead times by vendor or by product/service type, or order minimums, and ultimately customer deliveries can be affected by an order placed a single struggling vendor.
Inventory in the system is limited to finished goods and high value raw material, but is missing available components - without this info Purchasing can place orders for components already available onsite, or launch production for items already in finished goods.
Evacuation drills and spill containment drills haven’t occurred after facility moves or staff changes – management assumes the process works as originally documented, but 50% of staff don’t know the process. Without timing the drills, and debriefing about hiccups, the risks grow.
Are your audits catching process creep? – We hope so. If you have more than 3-5 findings during an external audit, creep is happening! Contact us for auditor refresher training.