The Value of well-defined NCR and CAR

  • Author – Chad Henry | Account Manager Texas Quality Assurance

Introduction to NCR’s “Nonconformance Reports” & CAR’s “Corrective Action Reports”

When it comes to operational excellence, fundamentals of QMS “Quality Management System” are critical. I would argue that nonconformities and corrective actions are the foundations of an effective quality management system (QMS). They represent the “boots on the ground” problems of production and the efforts taken to resolve them. And when the overall purpose of NCR/CAR is lost in an organization, the quality management system (QMS) becomes ineffective, the excess paperwork becomes an obstacle to production, and can lead to resentment and eventually collapse of the QMS. Conversely, when the overall purpose is clear and internalized, the QMS functions as a structure for effective collaboration, continual improvement of the business, and objective success that extends past the scope of the QMS.

Background on NCR’s “Nonconformance Reports” & CAR’s “Corrective Action Reports”

The most widely used standards for QMS include API Q1, API Q2, and ISO 9001; and each standard uses the same definitions for a nonconformity as defined in ISO 9000:2015 (see below).

ISO 9000:2015

Requirement – “need or expectation that is stated, generally implied or obligatory”

Nonconformity – “non-fulfillment of a requirement”

ISO 9001 focuses proper identification, control, and appropriate actions based on the nature of the nonconformity (see below); but how they are identified, and the means of control, and the critical thinking required for appropriate actions are where a QMS either succeeds or fails.

ISO 9001:2015

“…shall ensure that outputs that do not conform to their requirements are identified and controlled…” Section 8.7.1

“…shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services…” Section 8.7.1

The API standards (Q1 & Q2) both focus on the same ideas: identification, control, and proportional corrective actions with an added specification to consider the relevant responsibilities and authorities necessary to carry out the procedure (see below)

API Specification Q1

 shall maintain (a) documented procedure(s) to identify… responsibilities and authorities for addressing nonconforming product. API Q1 5.10.1

“The procedure… shall include controls for…product identification…;taking action to preclude its use…; API Q1 5.10.1

“The procedure…shall include controls for … documented evidence supporting the nonconformity is available to facilitate the determination of the cause…” API Q1 5.10.1

API Specification Q2

“…shall maintain a documented procedure to define the controls for identifying, documenting, and reporting nonconforming service execution and SRPs …” API 5.10.1

“The level of response shall be proportionate to the severity of the nonconformity…” API 5.10.1

“The procedure shall include identification of related responsibilities and authorities for addressing the nonconformances” API 5.10.1

Why do NCR’s and CAR’s?

The fact of the matter is clear: the existence of a well-organized and clear standard does not make a great quality program. So, the real question, if the goal is to build an effective QMS, is this: How does one satisfy the standard with minimum effort and maximum impact? And, more specifically why can NCR/CARs be the key to success/failure?

Poorly executed NCRs can cause the following issues:

  • Improperly and inconsistently documented NCR/CARs are almost entirely useless they do not achieve their intended goal. Furthermore if the data is not complete nor trustworthy, then management cannot and will not take actions. If this is the norm for an organization, then NCR/CARs are just a “box to check” and a hindrance to effective operation.
  • If reporting among different locations/branches of the company are inconsistent, then locations/branches of the company will receive undue scrutiny from management. And, if an managers and supervisors fear that reporting problems will penalize their group, then reporting will be purposely avoided as managers try to cause their group to seem outstanding in comparison. 
  • If overly trivial information is considered and tracked it will obscure the real issues associated with production, will cause a lower quality of reporting, can bury the management with excess paperwork and will ultimately backfire as managers report less to avoid the hassle.
  • If NCR/CAR details are not consistent (associated P/N not linked, drawings not referenced, categorized improperly, the MGMT cannot make decisions well and the process bogs down.

Striving for clear standards of reporting and a clear definition of what constitutes an NCR is the goal and is a key step in building an effective QMS

The solution and recommended approach

Step 1: Define the scope

Remember an NCR/CAR must be a non-fulfillment of a requirement, which means that it must be linked to some written text. Using this as a guide, set up a meeting with all involved personnel and crowd source a decent body potential issues that can be reported using NCRs and think critically about what text (process procedure, policy, form, WI, etc.) is being non-fulfilled.

Example of Defect Codes:

  1. Used wrong material (deviation from WI)
  2. Missing shipping manifest for parts (deviation from procedure)
  3. Lack of signature for production step (deviation from WI)
  4. Equipment found (and used) out of calibration (deviations from procedure)
  5. Work performed by employee with expired training (dev. From Procedures)

Step 2: Define the methods of correction

This area is subject to interpretation and minor tweaking, but generally the following categories apply across all businesses:

Example of Disposition Codes:

  • Rework – taking action to eliminate the nonconformity prior to delivery and/or completion of the product
  • Scrap – discard the product or abandon the service to eliminate the detected nonconformity, products and services shall be precluded from use
  • Leave as is (concession) – authorize its use, execution, and release or acceptance under concession by a relevant authority, or by regarding the nonconformance
  • Education/Instruction – retrain involved employees and/or supplement with additional instructions to prevent the recurrence of a nonconformity.
  • Corrective Action – taking appropriate action regarding the effects and potential effects of the nonconformity, includes redress regarding products and services already delivered

Step 3: Document these examples specifically in the QMS procedure for reference.

By tackling as many grey areas and making them either black or white, the QMS becomes simpler, and significantly more effective. Also, because no one’s memory is perfect, the procedure will ensure that reporting is both consistent across locations, but will remain.

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