3. 4. 5. 6. 7. 8. - rizzoassoc.com · Form QP‐5‐1, the Corrective/Preventive Action Report...

REFER TO THE CONTROLLED DOCUMENT LOCATED ON THE RIZZO EXTRANET FOR THE LATEST VERSION. COPIES PRINTED OR SAVED LOCALLY ARE UNCONTROLLED

Page 2 of 12 QP‐5, Rev. 8 July 23, 2013

QP‐5 Corrective Action, Preventive Action, and Continual Improvement‐Rev8\QP‐5 Rev 8 v21_0

© Paul C. Rizzo Associates, Inc., Proprietary and Confidential Work Product

TABLE OF CONTENTS

1. OBJECTIVE AND SCOPE ..................................................................................... 3

2. RESPONSIBILITIES ............................................................................................ 3

3. CPAR PROCESS FLOWCHART ............................................................................. 4

4. CPAR PROCEDURE .......................................................................................... 5

5. REVISIONS ..................................................................................................... 9

6. MONITORING .............................................................................................. 10

7. REFERENCES ................................................................................................ 11

8. CHANGE MANAGEMENT RECORD ...................................................................... 12





1. OBJECTIVE AND SCOPE

1.1. This procedure describes the methods used to process corrective and preventive actions and to document continual improvement opportunities.

2. RESPONSIBILITIES

2.1 The Originator is responsible for documenting any condition adverse to quality, health, safety, environmental (QHSE) issues, and/or preventive actions that they have identified on Form QP‐5‐1.

2.2 QHSE Management and Staff are responsible for:

2.2.1 Providing unique numbers for originated CPARs. 2.2.2 Logging CPARs into a database. 2.2.3 Classifying CPARs as Level 1, 2, 3 or 4 (see Paragraph 4.4.1) 2.2.4 Review CPARs to determine if a 10 CFR 21 or 10 CFR 50.55(e) screening is

required per QP‐8. 2.2.5 Reviewing open CPARs, notifying responsible managers of overdue

CPARs, and conducting follow‐up activities. 2.2.6 Review CPARs for closure. 2.2.7 Monitoring CPARs to determine if there are any trends.

2.3 The Responsible Manager is the Project Manager for project‐related CPARs or

the group or Business Unit Manager for other CPARs. Activities performed by the Responsible Manager include: 2.3.1 Determine underlying QHSE deficiencies and other factors that might be

causing or contributing to their occurrence. 2.3.2 Assign a CPAR individual (s) to ensure immediate corrective actions are

taken to mitigate consequences, develop a cause analysis (if required), develop corrective/preventive actions, and assign an expected completion date.

2.3.3 Manage staff to complete any corrective or preventive actions on a timely basis.

2.3.4 Respond to any corrective action overdue notices. 2.3.5 Communicate to QHSE staff if any changes to the CPAR are required,

including the expected completion date. 2.4 Business Unit Managers are responsible for allocating appropriate resources to

facilitate the timely completion of corrective actions.





3. CPAR PROCESS FLOWCHART

3.1 FIGURE QP‐5‐1: CORRECTIVE ACTION, PREVENTIVE ACTION, AND CONTINUAL IMPROVEMENT

FLOWCHART





4. CPAR PROCEDURE

4.1 ORIGINATING CPARS

4.1.1 Conditions Adverse to Quality, Health, Safety, Environmental (QHSE):

Form QP‐5‐1, the Corrective/Preventive Action Report (CPAR) may be initiated for any of the following conditions: a. Events that have caused or may potentially cause personnel injury,

illness and/or damage to assets, production or harm to the environment or third parties

b. Repetitive internal nonconformances (see QP‐4, Control of Nonconformances)

c. Internal audit finding

d. External audit finding (including audits of RIZZO by a client or audits performed by RIZZO of a supplier)

e. Finding resulting from a surveillance

f. Client complaint

g. Supplier nonconformance

h. Other (miscellaneous items not covered above)

4.1.2 Preventive Action: Form QP‐5‐1 may be initiated to document a

preventive action such as: a. Continual improvement opportunities

b. Identification of potential systemic problems

c. Management assessment of the QHSE Program

d. Client comments

e. Review of data regarding conformity to client requirements

f. Characteristics and trends including opportunities for improvement





4.2 Form QP‐5‐1 is used to document the condition adverse to QHSE, or preventive actions. Part 1 of Form QP‐5‐1 is completed by the Originator. Form QP‐5‐1 is then forwarded to QHSE Management and Staff.

4.3 QHSE Management or Staff logs accepted CPARs into the appropriate database

and assigns a CPAR number. CPAR numbers are assigned in sequence in the format of “XXX‐YY,” with XXX starting at 001 each year and YY being the last two digits of the year.

4.4 QHSE Management or Staff completes Part 2 of the CPAR form.

4.4.1 QHSE Management or Staff is responsible for evaluating the documented QHSE issue/condition and classifying it according to the following:

Level 1 – Recommendation/Continual Improvement Opportunity

Level 2 – Low Impact Condition Adverse to QHSE

Little or no potential for worker injury.

No impact on NPP facilities.

Limited or no potential environmental impact.

No potential for breach of NPP security.

Administrative issues only

Level 3 – Medium Impact Condition Adverse to QHSE

Moderate potential for worker injury.

Potential impact on NPP facilities that are not considered to be safety related.

Potential for local environmental impact.

Some potential for breach of NPP security.

Issues require significant rework.

Level 4 – Significant Condition Adverse to QHSE

Serious potential for worker injury.

Potential impact on a nuclear safety‐related structure, system, or component.

Potential for widespread environmental impact.

NPP security breach has moderate to high potential.

Issues have resulted in non‐conservative errors in a delivered document.





4.4.2 The condition adverse to QHSE is evaluated to determine if a 10 CFR 21 or 10 CFR 55.55(e) screening is required per RIZZO Procedure QP‐8, and the appropriate box is checked in Part 2 of Form QP‐5‐1. A screening is required for the following types of conditions:

A departure from the technical requirements defined in a Client procurement document or specified in early site permit information, a standard design certification or standard design approval (either by RIZZO or a sub‐tier supplier)

Deviations that could be a breakdown in the implementation of the RIZZO QHSE Program

Deviations that could be a breakdown in a sub‐tier supplier’s QHSE Program

Deviations, identified during receipt inspection, from the technical requirements in procurement documents for basic components received from a sub‐tier supplier

QHSE Management or Staff forwards any deviations requiring screening to the Business Unit Manager for further processing per RIZZO Procedure QP‐8.

4.5 The Responsible Manager assigns an individual(s) to ensure immediate

corrective actions are taken to mitigate consequences, develop a cause analysis to evaluate the cause (required for Level 2, 3, and 4 CPARs), develop a Corrective/Preventive Action Plan, and assign an expected completion date.

4.5.1 Level 2 and 3 CPARs require an apparent cause analysis. The cause

analysis should consider generic implications of the identified issue on other related items or activities, and determine underlying QHSE deficiencies and other factors that might be causing or contributing to their occurrence.

4.5.2 Level 4 CPARs require a root cause analysis and are required to include

actions to prevent recurrence.

4.5.3 Where the corrective or preventive action identifies new or changed hazards or the need for new or changed controls, proposed actions shall be taken through a risk assessment prior to implementation.





4.5.4 Any corrective or preventive action taken to eliminate the causes of actual and potential nonconformity(ies) shall be appropriate to the magnitude of problems and commensurate with the QHSE risk(s) encountered.

4.5.5 A Corrective/Preventive Action Plan (Part 3 of Form QP‐5‐1) is required to be developed within 30 days after Part 1 of Form QP‐5‐1 is signed by the originator, unless an alternative schedule is agreed upon by the Responsible Manager and QHSE Management.

4.5.6 The Responsible Manager signs and dates Part 3 of Form QP‐5‐1. The

form is then submitted to QHSE Management or Staff.

4.6 Notification for conditions adverse to QHSE is conducted by the Responsible Manager.

4.6.1 Any individuals impacted by the condition adverse to QHSE shall be

notified. 4.6.2 The Responsible Manager shall notify the client in the event of a project‐

related condition adverse to QHSE that could impact the results of the work. Other conditions will be reported to the Client per the client contract.

4.6.3 If a condition is determined to have a potential effect upon the safety of

a nuclear facility, the Client and NRC (or other regulatory authority, if different from the NRC) will be notified in accordance with 10 CFR 21, 10 CFR 50.55(e), or other applicable regulations and RIZZO Procedure QP‐8.

4.7 Once established, the Corrective/Preventive Action Plan is implemented. The

Responsible Manager is responsible for implementing immediate actions or corrections, to contain the problem until permanent changes can be implemented.

4.8 Overdue Corrective Actions are reviewed by QHSE Management, and brought to the attention of the Responsible Managers. 4.8.1 If a Corrective Action is open more than 60 days after the expected

completion date, QHSE Management shall escalate the issue to the appropriate Business Unit Manager and Responsible Manager to address





the timelines of the actions. If deemed necessary, QHSE Management is empowered to issue a stop work order to the project or subcontractor.

4.9 Upon completion of the actions described in the Corrective/Preventive Action

Plan, the Responsible Manager shall notify the QHSE Management or Staff. 4.10 Prior to closure by QHSE Management or Staff, the following shall be verified:

Actions taken are appropriate to the magnitude of the problems and the QHSE impacts encountered

The condition has been corrected, as required

Corrective actions have been implemented, as required

Occurrence or recurrence of the condition is prevented. Effectiveness may be evaluated based on the results of any one or combination of the following:

A review of completed documents

Follow‐up surveillance or audit

Interviews

Work observations

Trending of performance

Monitoring of performance metrics

4.10.1 If the corrective or preventive actions are not effective, the CPAR is returned to the Responsible Manager for further investigation and processing.

4.10.2 After the items listed in Paragraph 4.10.1 are verified, QHSE Management

or Staff describe the verification/follow up action(s), provides the actual completion date, checks the appropriate box to indicate whether the corrective actions are effective, and signs and dates Part 4 of

Form QP‐5‐1. 4.10.3 The completed Form QP‐5‐1 is maintained as a quality record in the

Quality Assurance files per RIZZO Procedure QP‐25. 5. REVISIONS

5.1 If it is determined that details of the finding, cause analysis, corrective/ preventive action are incomplete or inaccurate, Form QP‐5‐1 shall be revised.





5.2 If the correction/preventive actions are unable to be completed by the expected

completion date, the Responsible Manager is responsible for providing written notification to QHSE Management, including a description of the reasons for the extension request. QHSE Management shall review requests and evaluate based on the documentation provided. These extension requests and approvals shall be filed in the QHSE files per QP‐25.

5.3 Revised Form QP‐5‐1 shall be designated by R# placed as a suffix to the CPAR

number where “#” is equal to the revision number. 5.4 Superseded versions of Form QP‐5‐1 shall be voided. Documentation of

superseded versions of Form QP‐5‐1 are maintained in the QHSE files per QP‐25.

5.5 If audits, surveillances or other monitoring activities performed subsequent to CPAR closure indicate that the preventive or corrective actions were not effective, a CPAR may be reopened. Alternatively, a new CPAR may be initiated.

6. MONITORING

6.1 QHSE Management and Staff shall maintain a database of CPARs and periodically review the database for repetitive/systemic problems.

6.2 CPARs may be classified based on the following categories, or additional

categories if deemed appropriate:

Act of nature

Document control

Equipment malfunction

Failure to follow procedure

Human error

Insufficient planning/scheduling

Procedure insufficient

Supplier nonconformance

Training inadequate

Unanticipated field conditions





Work plan deficiency

Other

6.3 CPARs shall be evaluated on a quarterly basis to determine if there are any

trends in CPAR classification. 6.4 If deemed necessary, corrective actions shall be initiated for repetitive/systemic

issues described in CPARs.

7. REFERENCES

7.1. Title 10 of the Code of Federal Regulations, Part 21 (10 CFR 21), “Reporting of Defects and Noncompliance,” and Part 50, Section 50.55 (e), “Conditions of Construction Permits, Early Site Permits, Combined Licenses, and Manufacturing Licenses.”

7.2. RIZZO, QP‐4, “Control of Nonconformances.” 7.3. RIZZO, QP‐8, “10 CFR 21 Program Procedure.” 7.4. RIZZO, QP‐25, “Records Control.” 7.5. RIZZO, QP‐35, “Project Performance Review.” 7.6. RIZZO, Form QP‐5‐1, Corrective/Preventive Action Report (CPAR).

7.7. Health and Safety Executive (HSE), “Safety Assessment Principles for Nuclear Facilities”, United Kingdom Quality Standard, 2006 Edition, Rev 1.

7.8. International Atomic Energy Agency (IAEA) Safety Requirements No. GS‐R‐3, “The Management System for Facilities and Activities”, July 2006.

7.9. ISO 14001:2004, “Environmental Management Systems Requirements”

7.10. ISO 9001:2008, “Quality Management Systems”

7.11. OHSAS 18001:2007, “Occupational Health and Safety Standard”





8. CHANGE MANAGEMENT RECORD

REVISION NO.

DATE DESCRIPTIONS OF CHANGES/AFFECTED PAGES

0 01/24/2006 Original Procedure

1 04/25/2007 Revised Sections 3.0 and 5.0. Revised CPAR form.

2 02/07/2008 Added references to 10 CFR 50, Part 50.55(e) and QP‐8. Revised Paragraphs 5.2, 5.3, and 5.4. Added Section 10.0. Minor editorial changes throughout. Revised CPAR form.

3 03/28/2009 Revised Paragraph 5.6, Paragraph 5.7, Section 6.0 and Paragraph 8.4. Minor editorial changes throughout. Revised CPAR form.

4 08/31/2009 Added references to QP‐25. Deleted Section 2.0 and renumbered other sections. Revised Section 5.0. Revised Paragraphs 9.1 and 10.4. Added effective date to header.

5 03/30/2010 Revised Paragraph 4.11, Section 5.0, and Paragraph 10.3. Revised CPAR Form.

6 10/26/2010 Removed reference to NQA‐1‐2004 in Section 2.0. Revised definitions in Paragraphs 3.1 and 3.3. Revised CPAR Form and associated instructions in Section 4.0. Added reference to Procedure QP‐25 in Paragraph 7.5. Clarified documentation of continual improvement opportunities in Section 8.0. Clarified submittal of Corrective Action overdue notices in Paragraph 10.3.1. Deleted Figure QP 5‐1./All pages affected.

7 01/11/2012 Deleted reference to Quality Assurance Manual in Paragraph 2.2, added reference to QP‐35 in Section 2.5, and renumbered other paragraphs in Section 2.0. Identified CPAR Form as Form QP‐5‐1 in Paragraphs 2.6, 4.3, 7.4 and Sections 8.0 and 9.0. Described criteria for determining whether10 CFR 21 or 10 CFR 50.55(e) screening is required in Paragraph 4.3.3.1. Expanded discussion of closure activities in Paragraphs 4.3.5 through 4.3.7. Revised notification process in Section 6.0. Added Section 10.0 to address re‐opening CPARs and renumbered subsequent section. Added trending of CPARs in Section 11.2. Minor editorial changes throughout. All pages affected.

8 07/23/2013 Added flowchart and rearranged text to read like a procedure that can be followed per the flowchart. Added a description of responsibilities. Expanded CPARs to include health and safety and environmental incidents. Added a system for classifying CPARs. Added methods for emphasizing timeliness of corrective actions.

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