Writing and establishing process control procedures is

Writing and establishing process control procedures is a proactive measure designed to prevent nonconformities from occurring. By defining the standard method of operation, setting control limits, and outlining monitoring activities, these procedures aim to ensure process stability and capability. This action directly addresses potential causes of failure before they happen, which is the fundamental definition of preventive action. It is a cornerstone of a quality management system that focuses on building quality into the process rather than inspecting it in after the fact.

A. Disposition: This refers to the decision made regarding a nonconforming product or material (e.g., scrap, rework, accept-as-is), not the creation of a procedure.

B. Notification: This is the act of informing relevant parties about a quality issue or event, which is a communication step, not a process control development activity.

D. Corrective action: This is a reactive measure taken to eliminate the cause of a detected nonconformity to prevent its recurrence, whereas establishing procedures is proactive.

1. Gryna

F. M.

Chua

R. C. H.

& DeFeo

J. A. (2007). Juran's Quality Planning and Analysis: From Product Development Through Use (5th ed.). McGraw-Hill.

Page 216

Section 8.6

"Preventive Action": The text states

"Preventive action is directed toward removing the causes of potential quality problems... Examples of preventive action include... process control." This directly links the establishment of process control to preventive action.

2. Breyfogle III

F. W. (2015). The Certified Quality Engineer Handbook (4th ed.). ASQ Quality Press.

Page 81

Chapter 6

Section II.A.4

"Corrective and Preventive Action (CAPA)": The handbook defines preventive action as "action taken to eliminate the causes of a potential nonconformity

defect

or other undesirable situation

in order to prevent occurrence." Establishing a documented

controlled process is a primary method for preventing potential nonconformities.

3. International Organization for Standardization. (2005). ISO 9000:2005 Quality management systems — Fundamentals and vocabulary.

Clause 3.6.4

"preventive action": Defined as "action to eliminate the cause of a potential nonconformity or other undesirable potential situation." Writing and establishing process control procedures is a direct implementation of this principle

as it seeks to control a process to prevent undesirable situations (nonconformities) from arising.