Q: I would like to know the difference in application between Clauses 6.4.2 (Corrective Action) and 5.10 (Control of Nonconforming Product).
When you detect a nonconforming product, there is a nonconformity, and Clause 6.4.2 states the steps to correct nonconformities; I just see that in 6.4.2 b). Corrections for nonconforming product are detailed in 5.10.2 (am I right?). Is it possible to manage nonconforming product just as corrective action?
A: The primary discussion revolves around “product nonconformity” vs. “systemic” nonconformity.
Q1, 9th Edition, Clause 5.10, Control of Nonconforming Product relates specifically to the product(s) being manufactured by an organization. While Clause 6.4.2, Corrective Action could apply, it does not frequently enter the process for nonconforming product unless, as an example, a nonconforming condition is severe or extremely broad (1).
Corrective action for nonconforming product is normally referred to as a “disposition(2).” While this word “disposition” is not used in Q1, Clause 5.10, it has been used in relationship to nonconforming product in other quality management system requirements in regulated industries (e.g., U.S. nuclear industry).
In practice, if the word “disposition” may be used for Clause 5.10.2 as shown below, you will see that you are required to take one of these actions in order to meet Q1’s requirements for nonconforming product.
5.10.2 Nonconforming Product
“The organization shall address nonconforming product by performing one or more of the following:
a) repair or rework with subsequent inspection to meet specified requirements;
b) re-grade for alternative applications;
c) release under concession (see 5.10.3); and/or
<d) reject or scrap.”
* Excerpt from API Spec. Q1, 9th Edition
In this demonstration, disposition is a finite solution; whereas, corrective action would be a longer term solution requiring a root cause analysis (6.4.2c), including numerous other actions. Consider performing a root cause analysis on each and every nonconformance report written; your internal processes would soon come to a bottleneck.
Since nonconforming product may occur often (depending upon an organization’s processes and/or the process stability), dispositions allow an organization to process nonconforming conditions relatively efficiently.
However, when using this method, to be effective the organization would need to categorize each nonconformance report. Categorization could include, but not be limited to:
a) Type of disposition (see 5.10.2 above)
b) Type of observed nonconformity (why was the product nonconforming)
c) Citation (against what criteria were the product nonconforming; for example: drawing, specification, etc.)
d) Product type and other product information (product number, grade, diameter, etc.)
e) Machining or processing center
f) Inspection, measuring and monitoring equipment involved
g) Individuals involved, time of day, shift, etc. involved
h) Other relevant information
The purpose of categorization would be to collect and analyze nonconforming product data on a periodic basis in accordance with Q1, Clause 6.3, Analysis of Data. Collection of comprehensive nonconformity information would allow an organization to use different analysis techniques to optimize and deploy the results of the analyses performed against the established categorization codes (e.g., bar chart, radar diagram).
The analysis frequency would be left to the organization’s discretion; however, the following should be considered when establishing frequency:
a) Number of nonconformance reports to be analyzed
b) What quality objective (Q1, 4.1.3) is being measured
c) What key performance indicator (Q1, 6.2.1) is being measured
d) How the analyses results will be deployed for the management review process (Q1, 6.5)
Once a trend or trends have been identified, the requirements of Q1, Clause 6.4.2, Corrective Action should be implemented. Reason: the corrective action requirements outline the processes to deal with multiple / systemic nonconformities as shown, in part, in the following Q1 clause:
6.4.2 Corrective Action
“The organization shall maintain a documented procedure to correct nonconformities and to take corrective actions, both internally and within the supply chain, to eliminate the causes of nonconformities in order to minimize the likelihood of its recurrence. Corrective actions shall be appropriate to the effect(s) of the nonconformity encountered.
NOTE Corrective action can apply to both quality management system processes and nonconforming product trends.
The procedure shall identify requirements for:
a) reviewing a process nonconformity (including customer complaints)…”
* Excerpt from API Spec. Q1, 9th Edition
The corrective action process is meant to eliminate or at least mitigate the cause of a systemic nonconformity.
Footnotes:
(1) “Severe” or “extremely broad” is in the eye of the beholder; it could depend upon the following considerations as an example:
a) Cost of a product
b) Criticality of a product
c) Customer requirements
d) The breadth of the nonconformity (in other words, how bad is it?)
e) Other relevant factors
(2) Disposition: The power or liberty to control, direct, or dispose
— Bud Weightman
President, Qualified Specialists, International
