Investigating Cause - Are nonconformance Investigation Procedures Followed?

In my last blog I discussed the importance of evaluating responsibilities in an investigation and the associated documentation required as supporting evidence. Today’s blog will discuss investigating root causes as it relates to following established protocol and procedures.

In any failure or nonconformance investigation, the procedure(s) that govern the process under investigation play a key role in the determination of root causes. Once a nonconformance has been obtained, the investigation procedures must be detailed enough to answer or address the following:

-What are the necessary steps to control product disposition?
-What are the required approvals?
-Timeframes for acquiring approvals and product disposition?
-Timeframes for actual investigation?
-Development of a plan of action

Nonconformance investigation procedures must clearly define product disposition and the necessary approvals for the actions taken. Depending on the nature of the nonconformance, the risk that the organization is willing to assume, as well as the governing procedures, product disposition may dictate: use-as-is, quarantine, scrap, or rework. Whatever option is selected, the rationale for this decision must be clearly evident and governed by departmental procedures. A decision to use-as-is, for example, should not be left to the discretion of individuals who are not authorized to make such decisions, nor provide the justification for such use.

Nonconformance investigation procedures must also dictate the timeframes for acquiring approvals as well as the disposition of the product. In any nonconformance investigation, time plays a critical role and any unnecessary or timely delays may result in loss of vital information critical to the investigation. Therefore, it is essential that the investigator or other applicable personnel adhere to the established timeframe requirements in order that the flow of critical information may be evaluated in a timely fashion.

Nonconformance investigations procedures must also establish some clear foundation for a plan of action. This plan of action is not required to be so prescriptive as to prohibit or hinder the normal investigative flow. However, it should lay the preliminary foundation for the way in which the investigation is to flow. Action plans may incorporate as appropriate, to retest or resample; responsibilities for evaluating the data; as well as the required approvals of the data.

Depending on the nonconforming product as well as the procedures governing such products, each company must evaluate its own process and procedures for nonconformance investigation and revise as necessary to ensure that they continue to operate in a consistent state of control.