4-O system mandatory for recovery deviation by Jan. 1

4-O system mandatory in case of repair of deviation as of Jan. 1

SNA change in standards

When an inspection reveals that a company does not meet the standard, it is given the opportunity to remedy the deficiency. To correctly correct a nonconformity resulting from sampling, the company must look at the: Cause, Extent, Solution and Operationality. This is the so-called 4-O system.

The standards changes for the 4400-1 and 4400-2 are introduced through two adjustment reports (2021-271 and 2021-272-2) that are included in the new version of the Standards Manual as of 1-1-2022.

4-O system: what is it?

The idea behind the 4-O systematics is: identify the cause of the deviations found, perform full remediation and set up the organization so that the deviations will not occur in the future. As mentioned earlier, the 4-O system has four steps: Cause, Extent, Solution and Operationality. In a separate audit form, the inspector goes through these steps for each nonconformity to determine if the remediation is sufficient.

Whitepaper: Correcting deviations with 4-O system

Earlier we wrote briefly about applying the 4-O-system, but in the recently published white paper we discuss this method in more detail. On the basis of a practical example, we explain how companies can use the 4-O system for repairing deviations.