QP1040 Nonconformanity and Corrective Action

Policy:             Harrington Signal Inc. shall take action whenever necessary to eliminate nonconformities (nonconformance) in its QMS and prevent their recurrence. Corrective actions shall be appropriate to the effects of nonconformities encountered.

Purpose:         To outline the responsibilities and methods for identifying causes of nonconformities in the QMS, initiating corrective action(s), and performing follow-up to ensure that those corrective action(s) have been effective in eliminating the nonconformities.

Scope:             This procedure applies to all QMS nonconformities, whether identified during Internal Quality Audits or Management Reviews, by way of customer feedback, or by Management in general.

Responsibilities:

The Quality Manager is responsible for ensuring that corrective actions are accurate, understood, and implemented effectively and for reporting on corrective actions taken at Management Review Meetings.

All Managers are responsible for completing and following up on corrective actions for their respective areas.

All Employees are responsible for investigating and recording the cause(s) of nonconforming conditions when those tasks are assigned to them and for implementing corrective actions determined by this process.

Definitions:    CAR – Corrective action request (or report).

Conform – Be in agreement; act according to prevailing standards or customs.

Correction – Action taken to rectify/repair a known nonconformity.

Corrective Action – Act of eliminating the root cause of a known nonconformance, defect, or other undesirable situation to prevent its recurrence.

Nonconformity – output not conforming to a standard or specification; something that falls outside of defined critical limits; also known as “nonconformance” and includes complaints.

Root cause – Ultimate, or initiating, cause of an effect; usually identified through an exercise known as “root cause analysis”.

Procedure:

1.0         DETERMINING THE NEED FOR Corrective Action

    1. Variances between planned and actual performance of products or processes are easier to resolve if they’re identified before they become serious. An occasional variance, or nonconformity, may or may not be cause for concern: it has to be analyzed in context to determine if it requires simply a correction or if corrective action is needed.
    2. While actions may be taken to rectify or mitigate short-term problems, Quality Management (QM) and the affected Department Manager(s) shall give consideration to preventing their recurrence – or preventing similar potential problems from occurring in other areas – by making systemic changes to processes (i.e., taking corrective action).
    3. Many nonconformities are of a “lesser” nature. Harrington Signal Inc. needs to know they exist and should note them (see QP1030 CONTROL OF NONCONFORMING OUTPUTS), but it does not necessarily have to act on them beyond a correction. However, when analysis reveals a pattern or trend of nonconformities – or even a potential trend or non-random event – a corrective action is in order.

2.0         Initiating Corrective Action

2.1       Corrective actions are taken in response to found nonconformities. Requests for corrective action may result from:

·      Internal Quality Audits ·      Testing or inspection results
·      Management Reviews ·      Process reviews
·      Management, in general ·      Nonconformance reviews
·      Customer complaints or returns
    1. When it is determined that a corrective action is required, such action shall begin with entering a CAR/RMA. Every CAR/RMA/MRBA shall include a description of the problem, observation, or nonconformance and indicate when and where it was observed.
    4. The Quality Coordinator will work with key employees to investigate the cause, deal with the consequences, and/or take the necessary action(s) to correct and eliminate the recurrence of the problem, assign a target completion date, and notify the Quality Manager of the activity. The Quality Coordinator shall update the corrective action report accordingly.

3.0         Investigating the Cause

    1. Depending on the nature and scope of the situation under investigation, the Manager should enlist the aid of other employees or departments and form a team to investigate and address the problem. The team shall investigate the problem and attempt to determine the underlying (root) cause or causes and if similar nonconformities exist or could potentially occur with other outputs.
    2. In investigating root cause, the investigator should keep in mind that the apparent cause is rarely the root cause. It is often of value to identify the apparent cause and the contributing causes.[1] Further analysis using this process can lead to the root cause of the problem. Utilization of the 5-Why method: asking the question “Why?” five times, each time following up on the previous answer will aid the investigation into root cause.
    3. Any observations, measurements, and the results of the investigation on the CAR/RMA.
    4. The identified root cause(s) and recommended corrective actions shall be recorded on the CAR/RMA.

4.0         Taking Corrective Action

  1. Following the investigation, the Quality Coordinator shall review the results and consult with the appropriate employees to determine what corrective action(s) may be taken to eliminate the root cause of the problem.
  2. The Team will define the corrective action and a target date for its completion. The Quality Coordinator shall update CAR/RMA accordingly.
  4. The Quality Manager shall periodically (e.g., weekly) review the status of open corrective actions with Department Managers to help ensure actions are appropriate and are completed in a timely manner.
  5. If necessary, the person responsible for taking action shall update the risks and opportunities determined during planning,

5.0         Verification and Closure

  1. Quality Management shall ensure the integrity of the QMS during changes. The Quality Coordinator shall review the effectiveness of corrective actions taken and determine the appropriate follow-up or verification required. NOTE: To accurately judge the effectiveness of some corrective actions, one should allow them to work for a suitable period of time. The Quality Manager may elect to leave some CARs open for a period of time after corrective actions are taken to evaluate their reoccurrence.
  3. If it is determined that the corrective actions taken were ineffective, a new  CORRECTIVE ACTION REPORT shall be generated. NOTE: Ineffective corrective actions can result from improper or inaccurate root cause analysis. If so, a new nonconformance report and/or corrective action should be opened to correct the root cause analysis defect.

Effectiveness Criteria:

  • Closure of corrective actions in a timely manner
  • The problem requiring corrective action does not recur

[1]One commonly used technique is known as “The Five Whys”.

Revision History:

Revision Date Description of Changes Approved By
0.0 07/03/17 Initial Release Jim Theesfeld
1.0 8/17/18 Digitized version Todd Gifford
2.0 9/25/2020 Correct positional titles and responsibilities Todd Gifford