PFI-QA-SOP-09(0) Corrective Actions

STANDARD OPERATING PROCEDURE FOR CORRECTIVE ACTIONS

PSALMS FOOD INDUSTRIES LIMITED

ISO ISO ISO ISO

9001:2015 22000:2005 14001:2015 17025:2017

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 PFI-QA-SOP-09(0) Corrective Actions

1.0 Approvals

The signatures below certify that the procedure has been verified and accepted and
demonstrates that the signatories are aware of all the requirements contained herein and
are committed to ensuring their implementation.

Name Position Signature Date

Prepared by

Verified by Manager – Quality Control

Approval Chief Executive Officer

2.0 Amendment Record

This procedure is reviewed annually to ensure its continuing relevance to the Psalms Food
Industries Limited systems and the process that it describes.

3.0 Distribution List

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 PFI-QA-SOP-09(0) Corrective Actions
 Manager – Commercial
 Manager - Production
 Manager – Operations
 Manager – Sales
 Manager - Marketing
 Manager – Quality control
 Supervisors – Production, Sales, Marketing and Accounts.

4.0 Purpose

The purpose of this procedure is to provide guidance in the process of identifying,

evaluating, recording, investigating, correcting the causes of, and determining the
disposition of nonconforming processes, services, and work products (hereafter referred to
as nonconformance).

The cornerstone of corrective actions is written and retrievable records of actions taken
and follow-up monitoring to determine that corrective actions have been performed,
documented, and found to be effective.

5.0 Scope

This procedure applies to PFI Ltd work products and processes. This procedure directly
concerns the company’s quality assurance program.

6.0 Responsibility

6.1 Managers

6.1.1. Take action to control and correct nonconformance when they occur.

6.1.2. Ensure that corrective actions are performed, implemented, and

communicated.

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 PFI-QA-SOP-09(0) Corrective Actions
6.1.3. Review corrective actions that have been taken and approve or
recommend if further corrective actions are needed.

6.1.4. Complete appropriate sections of nonconformance and corrective action

records for systematic problems.

6.1.5. Facilitate the corrective action process.

6.1.6. Initiate corrective actions when needed, i.e. As a result of

complaints/feedback, nonconformance, audit results, management review, or other
findings.

6.1.7. Monitor corrections and corrective actions for trends, effectiveness, and
timely completion.

6.1.8. Maintain all records generated during corrections,

corrective actions and their investigation(s), including objective evidence of actions
taken

6.2 Supervisors

6.2.1. Initiate and/or participate in the completion of corrective actions.

6.2.2. Complete appropriate sections of the nonconformance and corrective
action records

7.0 Definitions

 Correction - action taken to render the work product acceptable for use by
eliminating the detected nonconformity.
 Corrective Action - The steps taken to eliminate the root cause(s) identified by a root
cause analysis.
 Deficiency – an alternate term used to describe a non-conformance.
 Nonconformance – A non-fulfillment of a specified or implied requirement of the
quality management system or of a quality work product.
 Observation – a perceived or detected abnormality or anomaly that is not out of
conformance to a specified or implied requirement; yet could possibly become a non-
conformance if not acted upon or can be improved upon.
 Preventive Action: Steps to mitigate or remove the underlying cause of a
nonconformance.
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 PFI-QA-SOP-09(0) Corrective Actions
 Root Cause(s) – The underlying reason (i.e. cause) that results in a nonconformance.
 Root Cause Analysis – A systematic method of problem solving that identifies the
root cause(s) of non-conformances.

8.0 Reference documents

ISO 9001:2015

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 PFI-QA-SOP-09(0) Corrective Actions

9.0 Process

9.1 Process flow diagram

Identify
nonconformance

Record

Investigate / Evaluate

Yes or No

Corrections only

NO
YES

Make correction
Root cause analysis

Develop corrective /
preventive action
plan Cycle until nonconformance
Record
does not recur

Implement plan

Evaluate during
internal audit &
Management review
Monitor effectiveness

Close out

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 PFI-QA-SOP-09(0) Corrective Actions

9.2 Identify nonconformance

9.2.1. Nonconformance can occur at various places within the quality system and
technical operations. Examples include customer complaints, unacceptable quality of
products, instrument problems, environmental problems that affect products,
purchased materials for use, staff observations, management reviews and audits.

9.2.2. Processes, services, and/or products considered to be nonconforming may be

identified in the following ways:

 Incoming product from suppliers

 Services provided by external sources (i.e. service contractors)

 Processes producing unacceptable results or products.

 Internal or External Quality Audits.

9.3 Review of Nonconformity

9.3.1. When a nonconformity occurs, the laboratory must take action to control and
correct it with actions appropriate to the effects of the nonconformities encountered.

9.3.2. A review of the consequences of the nonconformity is performed to determine

if a Correction or Corrective Action is warranted.

9.4 Correction

9.4.1. If a minor nonconformance is detected where a product was not affected but
absolute compliance to a statement of intent or clause of a standard was not met on
basis of objective evidence, it can be recorded as a correction only with
rectification actions recorded and closed.

9.4.2. An obvious trend in a repeated minor nonconformance can escalate it to a

corrective action.

9.5 Root Cause & Corrective Action

9.5.1. Once a nonconformance that impacts PFI product, processes, or service is

detected an evaluation of the need for action to eliminate the cause(s) will be
performed.

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9.5.2. The company determines if similar nonconformities exist or could potentially
occur.

9.5.3. An investigation to determine the root cause(s) of the problem will be initiated
in order to determine an effective corrective action.

9.5.4. Often the root cause is not obvious, therefore careful analysis of all potential
causes of the problem is required. Areas to investigate can include:

 Customer requirements

 The samples or sample specifications

 Methods and/or procedures

 Staff skills and training

 Consumables and/or vendors used

 Equipment and its calibration

 Environmental problems

9.5.5. Once the root cause has been determined potential corrective actions shall be
identified.

 Decide what can be done to prevent the problem from recurring.

 Determine how the solution will be implemented.

 Define who will be responsible for implementation.

 Evaluate the risks of implementing the solution.

9.5.6. The corrective action(s) most likely to eliminate the problem and to prevent a
recurrence shall be selected for implementation.
9.5.7. Changes required as a result of the investigation shall be recorded and
implemented (i.e. procedure revisions, training, resumption of work where it was
stopped due to the nonconformance, etc.)
9.5.8. The Management Representative closes the corrective action when there is
objective evidence that the actions are completed and effective.

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9.6 Monitoring for Effectiveness

9.6.1. Corrective actions that are implemented must be monitored to determine if

they are and/or continue to be effective.

9.6.2. The Managers can keep a completed action report open for a specified time to
monitor effectiveness, and then close the issue once it has been determined to be
effective.

9.6.3. Once an action report has been closed its effectiveness can still be determined
with an audit in the area affected by the original nonconformance.

9.6.4. In the event a corrective action is found to be ineffective, a new

nonconformance report will be initiated with a different root cause investigation to
determine why the first corrective action was not effective, if the true root cause was
determined, and to evaluate and identify the best corrective action to implement and
record.

9.6.5. This additional corrective action must also under go monitoring to determine its
effectiveness

9.7 Recording Correction(s) and Corrective Action(s)

Record nonconformance, investigation, correction, corrective action information in

nonconformance report.

10.0 Records

10.1. Nonconformance Reports

10.2. Notes created during Root Cause investigation(s)

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