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ISO 9001 is a quality management system of standards that assists organizations with ensuring that standards are met for service and quality, as well as statutory and regulatory compliance. The current standard is ISO 9001:2015 and is the international standard for quality management. One of central tenets of ISO 9001 is improvement.
Quality Management is an ever-changing process, requiring intentional review and continuous improvement. Every organization can always do better; purposeful evaluation of processes with the intent of looking for ways to improve can and will help drive positive change.
When an incident occurs, an ISO certified organization creates a corrective action. For example, a warehouse mislabeled a product, which was shipped to the customer. The incident must be investigated and a written plan for corrections is devised, helping to ensure that the incident is not repeated. However, this alone is a reactive approach – waiting to see if an incident reoccurs, versus actively working to ensure there is no recurrence.
By continuously auditing processes, documents, and procedures outside of a specific incident, the organization has taken a proactive approach to improvement. ISO quality management system uses a “Plan-Do-Check-Act” process for evaluating systems and seeking improvements:
Plan – Recognize an opportunity and plan a change
Do – Test the change
Check – Review the test, analyze the results, and identify what has been learned
Act – Take action based on what was learned from the previous step. If the change was unsuccessful, go through the cycle again.
In the case of the example above, the organization could implement regular audits/checks of the warehouse. This may include person-to-person interviews, order spot-checks, or product spot-checks. Another option may include on-site training for relevant personnel to ensure that team members understand the requirements. In addition, the organization should conduct at least one thorough audit annually.
In addition, the organization must look at other facets of the incident, not just the warehouse. To get to the root cause, they must look at the incident from all sides. This includes the order placement process and individuals involved, the shipping department staff and process, as well as the carrier and truck driver.
With this incident, let’s say the individual who mislabeled the product was a new employee who used the wrong labels. Some questions the organization might ask include:
- Was the order clearly received and understood?
- Who created the labels?
- Were the labels accurate and placed on the wrong product or were the labels incorrect and placed on the correct product?
- Who gave the labels to the individual who put the labels on?
- Were there multiple labels for multiple products, causing confusion?
- Are the products clearly labeled and stored correctly?
- What is the training process for the new employee?
- Who checks the work of the new employee?
- What is the flow of work that led to the labeling mistake?
- Were all parties authorized to do these activities as part of their job functions?
- Are all parties aware of their responsibilities, procedures and expectations?
- Who confirms that the product labels match the shipping paperwork?
- Why didn’t the driver confirm that the product matched the paperwork?
As you can see, there is much more to this incident than one employee making a mistake. A corrective action must look deeper into an incident. The purpose of continuous improvement must be considered with every incident and corrective action.
ISO 9001 requires that organizations look at issues from all sides, then create plans to improve processes, test the changes, analyze the effects of the changes, and take action. ISO certified organizations should take a proactive approach to processes, helping to prevent incidents from occurring, versus reacting to issues after they’ve arisen.
ChemCeed is an ISO 9001:2015 certified, woman-owned, minority-owned worldwide chemical supplier. For more information on our certifications, click here.