Posted by Zosi Team
- Perform Thorough Risk Assessments
Preventing foreign material in your production begins with robust risk assessments of your delivery and storage areas, production lines, building and facility perimeter. Don’t rush and be sure to pay attention to the details. Potential risks include loose floor aggregate, caulking in the ceiling or wall panels, overhead lights, nuts, bolts and screws in equipment, plastic or glass dials and plastic covers, chipping utensils and employee gloves, hair or jewelry. Consider areas of your perimeter where measures may be necessary to prevent foreign material contamination from cross contaminating interior areas. Record all potential foreign material contamination hazards.
- Assess Risk Likelihood, Severity and Detectability
With your list created, it’s time to score each potential hazard. Consider using a simple scale of one to five. First, consider the likelihood of the hazard from happening. A higher likelihood means a higher score. Once finished, it’s time to score each item again. This time consider how severe the problem would be should the hazard occur. It is also recommended to assess the detectability of the potential foreign material hazard. The detectability scale would be from low if it is detectable such as a 1 for metal if you have metal detection in place to high if it is not detectable such as a 5 for wood or plastic. The multiple the risk x severity x detectability to generate a risk priority number. This number represents the total risk for each hazard on your list. Higher risk hazards should be prioritized to establish mitigation measures.
- Perform Integrity Checks
Now that you’ve scored each risk, you should denote the frequency with which your team should assess them. For example, you might conduct integrity inspection checks once monthly for items scored between as low risk, weekly for items scored as moderate risk, daily for items scored as high risks.
- Define Standard Operating Procedures (SOPs)
How will you conduct each integrity check? What will you do if an integrity check fails? Thoroughly document these guidelines, otherwise known as standard operating procedures (SOPs) for each of your integrity checks. Note that it is okay to have identical SOPs for multiple checks. Always remember to include recordkeeping requirements!
- Delegate Responsibility
Conducting integrity checks as quickly as possible is never a one-man show. Instead, assign the responsibility of integrity checks to members across production, quality and maintenance staff. Checks should always be performed by the same staff although teams should be rotated periodically. These individuals must be familiar and trained properly in their respective SOPs.
- Internally Audit
Schedule and perform regular internal audits to ensure integrity checks are properly conducted and documented, including required corrective actions. Beyond this scheduled time, be sure to perform audits when you procure new equipment, build a new area or change the locations of certain machinery.
- Train Your Team
Foreign material control training helps your entire team understand how to prevent, detect, and respond to foreign material contamination. Zosi Learning offers online, self-paced solutions to assist you in developing a better understanding of foreign material control prevention methods, their limitations, and how to employ them in your facility.
Foreign Material Control
