8 Steps to Killer Corrective Actions: Fix it once, fix it forever
Mistakes in manufacturing, and life, cost us many times the cost of doing it right the first time! Merely re-working or replacing product kills the profit margin. Therefore, it’s worth spending some time investigating and correcting the problem that produced the NonConforming Product (NCP) at the source.
ISO 9001:2015 deals with NCP in two places: in 8.7 it discusses containment, segregation, and mitigation; and in 10.2 Nonconformity and corrective action. Here are steps to help each Corrective Action (CA) be a once-only event.
1) React to the nonconformity, take action to control and correct it, and deal with the consequences (which you started per 8.7.1). Whether the NC was a customer complaint, an internal QC catch, or a finding from an audit, the actions are the same. Define if any other outputs may be affected, recall if needed, segregate defectives and decide whether to re-work or replace.
2) Assemble a cross functional TEAM & evaluate needed actions to eliminate the cause(s): Repeat NCP is a fast way to lose a good customer. Is this a one- off or a potential repeat? Can this type of error or event occur on another line or process? If so, it’s faster, cheaper and easier to fix it now. All change affects the team, so solicit input from all involved and get buy-in.
3) Evaluate the potential causes: A Fishbone (Ishikawa) or 5-whys diagram, used properly, can uncover the roots of that NC ‘weed.’ Don’t blame an employee; look for system weaknesses in: staff limitations; the machine program or clarity of process instructions; materials; equipment tooling, maintenance; measurement devices; output monitoring; production work environment, storage and shipping; and changes in supplier processes too. Data helps identify the most likely cause of the NC.
4) Decide on a corrective action: You’ve already corrected/replaced the NCP in step 1 – Here your actions are addressing the cause. With proper evaluation in step 3, the right corrective action should be obvious.
5) Implement the action: if the cause created a NC once, it could happen again, so don’t wait on this. Update instructions, re-train, re-supply, re-configure, without delay.
6) Evaluate the effectiveness of the action: Remember you’re checking to see if the CA prevented the same issue from recurring. So it will often take several runs or events to determine if you chose the right action.
7) Standardize the new process, method, material, tool, etc.: Update other QMS documents affected, including the risk register. Check references in other process documents, inspection info & associated audit checklists, training tools, etc. And then train staff to the new process.
8) THANK the team. Change is hard, so recognize all contributors, and share the results – Celebrate what improved!