QP 7_1_2A (Risk Management)(6 May 2014)

WEATHERFORD AEROSPACE, INC. 1020 E. Columbia Street610 W. Third StreetWeatherford, TX 76086

DOCUMENT NO. QP 7.1.2 Number of Pages 12

QUALITY PROCEDURE

RISK MANAGEMENT

AS9100C – 7.1.2REVISION LEVEL: A

REVISION DATE: 6 May 2014REVISED BY AND DATE APPROVED BY AND DATE

(Billie Cornelius, Production Quality Manager)

APPROVED BY AND DATE(Mason Sinclair, Quality Manager/Process Owner)

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TABLE OF CONTENTS

WEATHERFORD AEROSPACE, INC. Document No.: QP 7.1.2Revision Level: B

RISK MANAGEMENT Revision Date: 6 May 2014

Revision History 3

1.0 Scope 4

2.0 Authority 4

3.0 Responsibility 4

4.0 References 4

5.0 Terms and Definitions 4

6.0 General Requirements 5

7.0 Detailed Requirements 5

8.0 Records 9

9.0 Notes 9

10.0 Index 9

Appendix A. Current and Ongoing Risk Management Activity 10

Appendix B. Applying Preventive Action for Risk Management 12

REVISION HISTORY

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Rev. Details Date

NC Original Issue 12 May 2013

A Added: 1.2 Intent and 1.2 Applicability 6 May 2014Changed: “Director of Quality Assurance” to “Quality Manager”Added: To 1.1 “Note: Future risk management shall take the form of preventive action per QP 14-100 (shall be superseded by QP 8.5.3). Added Appendix A. Current and Ongoing Risk Management Activity.Added Appendix B. Applying Preventive Action for Risk Management

1.0 SCOPE

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1.1 Purpose: This procedure provides guidelines for managing existing risk to the achievement of applicable requirements, as appropriate to the product.

Note: Future risk management shall take the form of preventive action per QP 14-100 (shall be superseded by QP 8.5.3).

1.2 Intent: This procedure is intended to address AS9100C, Clause 7.1.2 requirements for risk management.

1.3 Applicability: This procedure shall apply to all Departments involved in the realization of product, to the extent indicated.

2.0 AUTHORITY2.1 The Quality Manager has interpretive authority over this document and the right to

resolve

3.0 RESPONSIBILITY3.1 The Quality Manager is the process owner for this procedure.

3.2 Department Managers shall apply this procedure, as required, to support product conformity.

4.0 REFERENCESAS9100C Quality Management Systems – Requirements

QP 14-100 Preventive Action (shall be superseded by QP 8.5.3).

5.0 TERMS AND DEFINITIONSCONSEQUENCE: Outcome of an event affecting objectives.

LIKELIHOOD: Chance of something happening.

RISK: Effect of uncertainty on objectives.

RISK CRITERIA: Terms of reference against which the significance of a risk is evaluated.

RISK IDENTIFICATION: Process of finding, recognizing and describing risks.

RISK SOURCE: Element which alone or in combination has the intrinsic potential to give rise to risk.

6.0 GENERAL REQUIREMENTS

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6.1 Weatherford Aerospace, Inc. (WAI) shall implement and maintain risk management including the:

a) Assignment of responsibility for risk management;

b) Definition of risk criteria;

c) Identification, assessment and communication of risks;

d) Actions to mitigate risks that exceed risk acceptance criteria; and,

e) Acceptance of risks remaining after implementation of mitigating actions.

6.2 Existing risk management activity forms an integral part of this document.

6.3 Future risk management activity shall be conducted per procedure QP 14-100 Preventive Action (shall be superseded by QP 8.5.3) using Form QA 1011 Preventive Action Form. See Appendix B.

7.0 DETAILED REQUIREMENTS7.1 Responsibility

7.1.1 Department Managers are responsible for conducting risk management for current risks in accordance with this procedure. Subordinate personnel may be tasked by Management to accomplish risk management.

7.1.2 Future risk management activity shall be conducted by Department Managers as preventive action per procedure QP 14-100 Preventive Action Procedure (shall be superseded by QP 8.5.3).

7.2 Risk Criteria7.2.1 Cause or Source of Risk

7.2.1.1 The cause or source of risk shall be identified in relation to the identified risk. Potential causes may be identified using FMEA, the Ishikawa diagram or other quality tools.

7.2.1.2 Some current causes and sources of risk are identified in Appendix A.

7.2.1.3 Future cause or source of risk shall identified as the cause of potential nonconformity on Form QA 1011.

7.2.2 Likelihood7.2.2.1 The likelihood that a risk may occur, based upon the cause or source,

must be determined.

7.2.2.2 The likelihood can be ranked as shown in Table 1.

Table 1. Risk Likelihood Ranking

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Likelihood Description of Likelihood RankingAlmost Certain

Can be expected to occur in most circumstances; more than 75% chance of occurring; complex processes with minimal checks and balances; impacting factors outside WAI control.

5

Likely Will probably occur in most circumstances; 50-75% chance of occurring; complex process with some checks and balances; impacting factors outside WAI control.

4

Possible Might occur at some time: 25-50% chance of occurring; previous audits/reports indicate non-compliance; complex process with extensive checks and balances; impacting factors outside WAI control.

3

Unlikely Could occur at some time; less than 25% chance of occurring; noncomplex process and/or existence of checks and balances.

2

Rare May only occur in exceptional circumstances; simple process; no previous incidence of non-compliance.

1

7.2.2.3 The likelihood for some current identified risks is identified in Appendix A.

7.2.2.4 Future risk likelihood shall be identified as part of the potential nonconformity on Form QA 1011.

7.2.3 Consequences7.2.3.1 Consequences of risk reflect the severity of continued risk.

7.2.3.2 Consequences can be ranked as shown in Table 2.

Table 2. Risk Consequence Ranking

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Effect Description of Possible Consequence RankingHigh Process does not conform to Customer

requirements; product not acceptable.

Nonconforming product; requiring scrap or replacement.

On-time delivery does not occur; product is 5 or more days late.

3

Medium Process does not conform to Customer requirements; disposition required.

Nonconforming product; requiring rework or repair. Conformance achieved through significant hand-finish work.

On-time delivery does not occur; product is 2 to 5 days late.

2

Low Process conforms or acceptable to approved deviation.

Conforming product or product requiring minor hand-finish work prior to acceptance.

Delivery is on-time or does not exceed 24 hours.

1

7.2.3.3 The consequences of some currently identified risks are shown in Appendix A.

7.2.3.4 Future consequences of risk shall form part of the potential nonconformity identified on Form QA 1011.

7.3 Identification of Risk7.3.1 Risk may be identified through the following:

a) Analysis of Data

b) Audit Results

7.3.2 Some current risks have been identified and included in Appendix A.

7.3.3 Future risks shall be identified as potential nonconformities using Form QA 1011 Preventive Action Form.

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7.4 Assessment of Risk7.4.1 Risk shall be assessed based upon their criteria (cause, likelihood and

consequences).

7.4.2 The assessment of risk shall be used to determine whether a risk is acceptable or requires risk mitigation.

7.4.3 Risk may be assessed using the following table.

Table 3. Risk Assessment

ConsequenceRanking

Assessment

3 RM RM RM RM RM

2 A RM RM RM RM

1 A A A RM RM

Likelihood Ranking

1 2 3 4 5

Key:A – Acceptable (Low) risk. No risk mitigation required.

RM – Risk mitigation required.

7.4.4 The assessment of some current risks has been identified in Appendix A.

7.4.5 Future risk assessments shall be included as a part of the description for potential nonconformities using Form QA 1011.

7.5 Communication of Risk7.5.1 Current risks are communicated and mitigated as an integral part of QMS

processes.

7.5.2 Future risks shall be communicated through the use of Form QA 1011 Preventive Action Form.

7.5.3 Open and ongoing Preventive Actions shall be regularly reported as Management Review Input.

7.6 Risk Mitigation7.6.1 Assessment of risk shall identify the need for risk mitigation.

7.6.2 Future risk mitigation using Form QA 1011 shall take the form of:

a) Action needed to prevent potential nonconformity; and,

b) Action implemented to prevent potential nonconformity.

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7.7 Risk Acceptance7.7.1 Risks may be accepted based upon the assessment of risk and the results of

Table 3. and following risk mitigation that reduces both the likelihood and consequence of risk.

7.7.2 Future risk acceptance shall reflect the acceptability of the preventive actions implemented based upon the:

a) Results of action taken; and,

b) Review of preventive action effectiveness.

7.7.3 Ongoing risk and risk mitigation activity is acceptable where the review of the preventive action effectiveness is recorded as ‘effective (closed)’.

8.0 RECORDS8.1 Records shall be maintained per QP 4.2.4 Control of Records.

9.0 NOTES9.1 None required.

10.0 INDEX10.1 Not required.

APPENDIX A. Current and Ongoing Risk Management Activity

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A.1 Contracts

Process: Contracts

Responsibility: Contracts Department

Description of Risk: Contracts may be accepted that exceed WAI capabilities.

Cause or Source of Risk: Single Reviewer (Estimator)

Likelihood Ranking: 5 – Almost Certain

Consequence Ranking: 3 - High

Assessment of Risk: RM – Risk mitigation required

Risk Mitigation: Independent review of Customer Purchase Orders (2 members of Contracts Department, 1 representative of the Quality Department, and 1 representative from the Engineering Department) to verify availability of processes, equipment and capabilities. Evidence of review with signatures on Form WA-80 Contracts Review

Communication of Risk: Requirement incorporated into procedure QP 7.2 Determination and Review of Customer Requirements. Method employs Figure 6.1.2 Contracts Risk Assessment, found in procedure QP 7.2.

Acceptance: Risk accepted with mitigation (Note: Acceptance may require additional resources to meet contracts).

A.2 Planning Process: Planning

Responsibility: Engineering Department

Description of Risk: Inspection operations (QC Inspect) in shop orders lack required inspection details (for example, inspection media, calibrated inspection devices, reference to required dimensional details).

Cause or Source of Risk: Limited number of Manufacturing Outline Planning Personnel (2)/ High volume of planning developed daily.

Likelihood Ranking: 4 - Likely

Consequence Ranking: 3 - High


Risk Mitigation: Independent review of manufacturing planning to ensure incorporation of required detail, with password protected acceptance of planning prior to printing required.

Communication of Risk: Requirement incorporated into procedure WA-5.2 Manufacturing Planning and Shop Order Software (WAI proprietary).

Acceptance: Risk accepted with ongoing mitigation.

A.3 Purchasing Process: Purchasing

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Responsibility: Purchasing Department

Description of Risk: Purchase Order lacks sufficient detail to ensure conformity of purchased products to requirements.

Cause or Source of Risk: Limited number of Purchasing Agents (1) available/depth of knowledge available.

Likelihood Ranking: 4 – Likely

Consequence Ranking: 3 – High


Risk Mitigation: Independent review of Purchase Order by Quality Department Personnel required to ensure incorporation of required product and service requirements.

Communication of Risk: Requirement incorporated into procedure QP 7.4 Purchasing Procedure.


A.4 Manufacturing Process: Manufacturing

Responsibility: Scribe Department

Description of Risk: Incorrect tool use due to similarity in scribe tools available (for example, left and right hands, -1 vs. -2).

Likelihood Ranking: 3 – Possible

Consequence Ranking: 3 – High


Risk Mitigation: Incorporation of Manufacturing Verification operation into Shop Order instructions to ensure proper tool is used. Verification of appropriate tool use by Lead Scriber or designated Scribe Department Personnel.


APPENDIX B. Applying Preventive Action for Risk ManagementB.1 Preventive Action may be employed for risk management provided all requirements are

addressed.

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B.2 Procedure QP 14-100 Preventive Action (shall be superseded by QP 8.5.3) shall be used.

B.2 The instructions for using Form QA 1011 Preventive Action Form are as follows:

B.3.1 Potential Nonconformity shall include:

a) Description of Risk

b) Likelihood of Risk

c) Consequence of Risk

B.3.2 Cause of Potential Nonconformity shall include:

a) Cause or Source of Risk

B.3.3 Action Needed to Prevent Potential Nonconformity shall include:

a) Risk Mitigation

B.3.4 Action Implemented to Prevent Potential Nonconformity shall include:

a) Risk Mitigation

b) Communication of Risk (in other words, internal communication using appropriate documents)

B.3.5 Results of Actions Taken shall include:

a) The results of the risk mitigation activity

B.3.6 Review of Preventive Action Effectiveness shall include:

a) Acceptance based upon results of risk mitigation

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Documents

QP 7_1_2A (Risk Management)(6 May 2014)