DOCUMENT REVISION HISTORY PAGE - …documents.dmetrain.com/custom/1542/courses/Z90c0010/90c0010_rev… · DOCUMENT REVISION HISTORY PAGE ... Clarified scope of SOP. ... GHTF/SG2/N54R8:2006

DOCUMENT REVISION HISTORY PAGE

Document Number: Rev: Page:

90C0010 X 2 of 20 Title: Corrective and Preventive Action

Revision History Of Document

Rev

CO

Number

Description of Change

Author

Effective Date

FI 72 Implementation of a procedure identifying the MG 6/29/92 corrective action process.

A 319 Converted document to Word 6.0 format, revised G.P. 10/4/96 CAR and SCAR forms, added flowcharts, incorporated “Preventive Action” per new GMP’s

B 494 Corrected referenced documents. Added reference to G.P. 8/14/97 C/A as result of audits. Added response due date for internal C/A’s. Separated acceptable response from

audit close. Added reqm’t for attaching periodic supplier data. Added CAR & SCAR Logs.

C 709 Added requirement to evaluate “Effectiveness of C/A”. G.P. 8/19/98

D 1118 Added requirement for establishing a scheduled G.P. 12/06/00 effectiveness review date at the time of proposed C/A review. Added requirement for documenting the objective evidence used to evaluate the effectiveness of C/A or P/A. Added requirement for escalating

delinquent responses through successively higher levels of management. Established response time as 60 calendar days for CARs and SCARs. Revised format of CAR & SCAR forms. Clarified responsibilities for responsible manager. Clarified scope of SOP. Revised format of CAR & SCAR Logs. Added CAPA

Flowchart to procedure. Revised CAR & SCAR flowcharts.

E 1771 Revised section 5.2 to address situations where a G.P. 03-27-03 Supplier uses their own internal form to respond to a SCAR. Reduced the time for SCAR response from 60 to 30 days. Revised 5.2.2 to remove unverifiable requirements.

F 2044 Corrected SCAR Flowchart to match timeframe G.P. 09-23-05 specified in 5.2.1. Replaced references to figures 1 through 4

with actual form numbers.

ZOLL Form Number: 90A0001-A03 Form REV Level: J





Rev

CO

Number


Author

Effective Date

G 2635 Clarify “Purpose” (section 1) and “Scope” (section 2). Insert 90E0492 as an applicable document (section 3). Annotate and reference CAPA diagram as Figure 1 (section 4). Re-define and clarify CAPA diagram (Figure 1). Reference SOP 90F0030 in the definition of acronyms “CAR” and “SCAR” in Figure 1. Reference document 90E0026 (sections 5.1.1 and 5.2.1) when evaluating effectiveness of CAPA. Insert section 5.3 (Management Review).

S.G. 05-22-09

H 2782 Separate Service process from the MRB process – Update Figure 1 (Close Loop CAPA Process diagram) to remove reference to Nonconforming Material SOP during product service.

S.G. 04-19-10

J 3116 Remove block for form 90F0072-A04 from Fig 1. - Close Loop V.B. 08-31-12 CAPA Process with CAPA inputs and CAPA output flow chart.

K 3143 Clarified the 90C0010-A01 (CAR) and the 90C0010-A02 A.M. 10-12-12 (SCAR) forms based on feedback from the 2012 ISO Audit By adding definitions at the bottom of each form. Replaced the word “Lifecor” with “ZOLL” in the document. Updated Section 5.1.2 and 5.2.2 and the Internal C/A Flowchart and

the Supplier C/A Flowchart with language consistent with the definitions noted on forms 90C0010-A01 and 90C0010-A02.

L 3534 Removed QA and added Supplier QE to the SCAR process. L.P./S.H. 2-26-14 Added Supplier QE MGR and Purchasing Manager to Zoll Supplier Supplier Corrective Action Request Form.

M 3568 Add Risk Management, Device Recall and the MDR, Vigilance, MPR Reporting, Mandatory Notification SOPs as applicable documents and in Figure 1. Modified Figure 1 to reflect updated business model (removed form 90E0012-A01 and replaced Lifecor with Manufacturing).

L.F. 07-30-14

N 3870 Moved section 5.3 to 5.4. Inserted section 5.3 to address the 2015 FDA 483 observations 2, 3, and 6 (ZOLL action item 3) to require the collection of distributor incident & DMEPOS complaint data, and as such, apply appropriate statistical analysis of the collected data. Added 90C0014 SOP and GHTF/SG2/N54R8:2006 in section 3 (Applicable documents). Updated CAPA flowchart to include distributor incident & DMEPOS complaint data.

S.G. 04-29-15

R 3896 Moved section 5.4 to 5.5. Inserted section 5.4 to address 2015 FDA 483 observations 3 and 6 to require the statistical analysis of ZMC’s complaint and service data. Updates the risk ranking table in 5.3 to include severity levels 4 & 5. Clarified that analysis in 5.3 is performed by RA.

A.P. 05-29-15






Rev

CO

Number


Author

Effective Date

S 3910 Updated Section 5.4 to reflect that the risk and/or rate method can be utilized for the Monthly review of ZMC service and complaint Data.

A.P. 06-10-15

T 3959 Combined Section 5.3 and 5.4 to describe the periodic review of ZMC complaint and service data. Removed the periodic review of distributor data based the FDA’s recommendation for ZMC to investigate all Distributor Incident/Complaint files, made during a Regulatory Meeting between ZMC and FDA on 07/13/2015. Updated Figure 1 to remove Distributor Incident/Complaint data as an input to the CAPA SOP as this will now be captured via the Complaint Handling SOP.

A.P. 08-31-15

U 4002 Added language to section 4 to clearly define when a formal CAPA is required and when it is discretionary. Added reference to 90E0021-A12 process interaction diagram. Updated 5.1.2 to specify the closeout meeting date for corrections to 483 observations and warning letter items and a minimum of 2 years for retroactive reviews. Added section numbering to Section 5.3. Added new sections 5.3.3 SPC Evaluation and 5.3.4 Failure Mode Review. Clarified process for starting a formal investigation based on the periodic review of complaint and service data in Section 5.3

G.P. 01-13-16

V 4236 Removed 90E0011 System Problem Reporting as an applicable J.K. 04-05-16 Document, source of quality data acronyms, and Figure 1 Close

Loop CAPA Process with CAPA Inputs and CAPA Output diagram as SPR’s are not a required CAPA input.

W 4300 5.1.2. Responsible Department Manager: Added requirement to

ensure re-training is conducted as a corrective action for CARs initiated due to a product malfunction caused by inadequate execution of a process.

TEL 04-25-16

W Amendment Deleted blank 5.3 step, moved 5.4 up to 5.3 and 5.5 to up to 5.4. TEL 05-16-16

X 4733 Updated Figure 1 to include External Audits and FDA 483 Warning And ISO 13485 Nonconformities as inputs to the CAPA process

JLD 2-16-17


ZOLL Document Number: 90C0010 Page 5 of 20 Corrective and Preventive Action REV X __________________________________________________________________________________

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1.0 PURPOSE

This procedure describes the process for ensuring that prompt and effective corrective or preventive actions are taken when an analysis of quality data, disposition of nonconforming material by ZOLL’s Material Review Board, or an observation identifies the needs for Corrective or Preventive Action (CAPA).

2.0 SCOPE

The scope of this procedure is to encompass all sources of quality data as input to the CAPA process at ZOLL (see Figure 1) as well as provide a mechanism for the review of CAPA data.

Further, internal and supplier corrective action procedures (CARs and SCARs respectively) are detailed in this document. Other sources of quality data, other than CARs and SCARs, have their own respective procedures that also serve as input to the CAPA process (see Figure 1).

3.0 APPLICABLE DOCUMENTS

90C0010-A01 Corrective Action Request (CAR)

90C0010-A02 Supplier Corrective Action Request (SCAR)

90C0010-A03 Corrective Action Request Log

90C0010-A04 Supplier Corrective Action Request Log

90C0014 Failure Modes, Effects, and Criticality Analysis Procedure

90C0023 Device Recall SOP

90C0052 Risk Management

90E0002 Quality Audit SOP

90E0012 Receipt and Evaluation of Product Complaints SOP

90E0021-A12 ISO 13485:2012 Process Interaction Diagram: Clause 8.5 – Improvement

90E0026 Sampling Inspection and Statistical Techniques SOP

90E0492 Corporate Quality Council SOP

90E0549 MDR, Vigilance, MPR Reporting, Mandatory Notification SOP

90F0030 Nonconforming Material SOP

GHTF/SG2/N54R8:2006 Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices


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4.0 CAPA OVERVIEW

A formal CAPA is required in the following circumstances:

Nonconforming material is identified in finished goods stock per 90F0030.

Nonconforming material has a Severity Level >= 4 per 90F0030.

Periodic data analysis of supplier/part number calculates a severity and occurrence level (SOL) >= 8 per 90F0030.

Periodic data analysis of top-level BOM part number/defects per month calculates an SOL >= 8 per 90F0030.

Periodic data analysis of complaint data calculates the rate of a reported problem exceeds the upper rate threshold per 90C0010 and a subsequent SPC analysis/failure mode review by RA identifies the need for a formal investigation.

Periodic data analysis of service data calculates the rate of a reported problem exceeds the upper rate threshold per 90C0010 and a subsequent SPC analysis/failure mode review by RA identifies the need for a formal investigation.

A product malfunction has directly caused or contributed to a patient death or serious injury.

Management review identifies the need for a formal CAPA per 90E0492.

An external audit finding or observation has been issued (FDA 483, warning letter or ISO 13845 Nonconformity).

A CAPA is discretionary in all other situations.

Figure 1 identifies the various sources of quality data that serve as key process inputs to the closed loop CAPA process and which result in a controlled quality change output. A description of each quality data type and the associated ZOLL procedure number is provided.

ZOLL Document Number: 90C0010 Page 7 of 20 Corrective and Preventive Action REV X _______________________________________________________________________________________________________________________________________________________________________________________________________________________

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Supplier

Manufacturing

Incoming Inspection

90F0029 SOP

Work Order and In-process Assembly /

Inspection / Test

Various internal SOPs

Incoming Inspection Test

Report

90F0029-A01

Unsatisfactory Condition Report

90F0030-A02

Outside Zoll Manufacturing

Product Service

90F0072 SOP

Complaint?

Complaint Report Form

90E0012-A01

Receipt and Evaluation of Product

Complaints

90E0012 SOP

CAR Form

90C0010-A01

SCAR Form

90C0010-A02

Y

N

AuditsQuality Audits

90E0002 SOP

Audit Report

90E0002-A02

CAR Form

90C0010-A01

SCAR Form

90C0010-A02

SCAR Form

90C0010-A02

Nonconforming Material

90F0030 SOP


90F0030 SOP


Disposition Form

90F0030-A01


Disposition Form

90F0030-A01

Service Report

90F0072-A03

CAPACorrective and

Preventive Action90C0010 SOP

QUALITY

DATA

INPUT

QUALITY

CHANGE

OUTPUT

Investigate Root

Cause

Determine Corrective

Action

Re-training Only?

Training Log

Effectiveness Review

Sampling Inspection and

Statistical Techniques

90E0026 SOP

Y

N

Change Requests and Change Orders

90A0023 SOP

Risk Assessment Acceptable?

N

Y

Design or Process Change?

N

Implement Change

Change Order and

Training Log

Design and/or Process

Verification or Validation

Pass

Y

N

Close Loop CAPA Process

ZOLL

Routine Service

Management Review

Corporate Quality Council

90E0492 SOP

And/Or

And/Or

Y

Risk Management90C0052

Device Recall Procedure90C0023

Does substantial risk

to already distributed product exist?

MDR, Vigilance, MPR Reporting, Mandatory

Notification SOP 90E0549

Is Complaint

Reportable?

Y

Y

N

N

N

External Audit

FDA 483 Warning Letter or

ISO 13485 Nonconformity

Figure 1: Close Loop CAPA Process with CAPA Inputs and CAPA Output.


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SOURCES OF QUALITY DATA - ACRONYMS (FIGURE 1) CAR: Corrective Action Request – generated when an analysis of quality data, disposition of

nonconforming material by the Material Review Board (per 90F0030), or an observation identifies the need for Corrective or Preventive Action (see 90C0010 – Corrective and Preventive Action SOP).

SCAR: Supplier Corrective Action Request – generated when an analysis of quality data,

disposition of nonconforming material by the Material Review Board (per 90F0030), or an observation identifies the need for Supplier Corrective Action (see 90C0010 – Corrective and Preventive Action SOP).

AFR: Audit Finding Report – generated when the results of an internal or supplier audit

indicate areas / activities or areas for improvement (see 90E0002 – Audit SOP). CRF: Complaint Report Form – generated when any written, electronic, or oral communication

alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution (see 90E0012 – Complaint Handling SOP).

ZOLL Document Number: 90C0010 Page 9 of 20 Corrective and Preventive Action REV X _________________________________________________________________________________

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5.0 RESPONSIBILITIES AND PROCEDURES

Each ZOLL employee has the authority to, and responsibility for, initiating corrective or preventive action, through QA, when a quality problem or potential quality problem is identified.

5.1 Internal Corrective Actions

5.1.1 Quality Assurance

When an analysis of process or work operation, disposition by ZOLL’s Material Review Board (see 90F0030), review of quality records (including trend analysis), or observation identifies the need for investigation and corrective or preventive action, Quality Assurance is responsible for:

Communicating in writing the need for corrective or preventive action via a Corrective Action Request (form 90C0010-A01) to the manager of the responsible department with a response due date (usually 60 calendar days from issue date).

Assigning a number and logging the CAR in the Corrective Action Request Log (form 90C0010-A03).

Reviewing CAR responses for adequacy.

Escalating delinquent responses through successive levels of management until an acceptable response is received.

Indicating in the CAR Log the receipt of an acceptable response.

Resubmitting the CAR in the event of insufficient response.

Upon receipt of an acceptable response, determining and recording the planned date for a review of the effectiveness of the corrective or preventive action.

Evaluating the effectiveness of the corrective or preventive action at the scheduled time using any statistical technique defined in 90E0026.

Documenting the objective evidence upon which the decision of the effectiveness was made.

Closing out the CAR after verifying the effectiveness of the corrective or preventive action.

5.1.2. Responsible Department Manager

The Manager of the department responsible for the situation requiring corrective or preventive action is responsible for:

Investigating and determining root causes, or potential causes for the stated deficiencies / non-compliances.

Determining effective corrective or preventive action.

Completing the Correction, Root Cause and Corrective Action portion of the CAR, indicating the projected completion date for implementation of the corrective or preventive action.

Signing, dating and returning the CAR to QA by the response due date.


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Implementing the corrective or preventive action by the projected completion date.

Ensuring re-training is conducted as a corrective action for CARs initiated due to a product malfunction caused by inadequate execution of a process.

*Note – for FDA 483 Observations or warning letter items ensure the correction encompasses the time period back to the 483 close-out meeting date. When a correction involves a retroactive review of data ensure the review start date is a minimum of 2 years in the past.

5.2 Supplier Corrective Action Requests

5.2.1 Supplier Quality Engineering

When an analysis of process or work operation, disposition by ZOLL’s Material Review Board (see 90F0030), review of quality records (including trend analysis), or observation identifies the need for supplier investigation and corrective or preventive action, Supplier Quality Engineering is responsible for:

Communicating in writing the need for corrective or preventive action via a Supplier Corrective Action Request (form 90C0010-A02) to the responsible supplier with a response due date (usually 30 calendar days from issue date).

Assigning a number to the SCAR and logging it into the SCAR log (form 90C0010-A04).

Reviewing SCAR responses for adequacy and completeness.

Notifying the Supplier in the event of delinquent, inadequate, or incomplete responses.

Indicating in the SCAR log the receipt of an acceptable response.

Upon receipt of an acceptable response, determining and recording the planned date for a review of the effectiveness of the corrective or preventive action.

Evaluating the effectiveness of the corrective or preventive action at the scheduled time using any statistical technique defined in 90E0026.

Documenting the objective evidence upon which the decision of the effectiveness was made.

Closing out the SCAR after verifying the effectiveness of the corrective or preventive action.

5.2.2 The Supplier’s authorized representative is responsible for the following:

*Completing the Correction, Root Cause and Corrective Action portion of the SCAR, indicating the projected completion date for implementation of the corrective or preventive action.

*Signing, dating and returning the SCAR to Supplier Quality Engineer by the response due date.

* Note: Suppliers may elect to document the corrective action investigation and response on their own internal forms. In these cases, the supplier’s form shall be attached to the Supplier Quality Engineer copy of the SCAR.


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5.3 Periodic Analysis of ZOLL Manufacturing’s Complaint and Service Data

ZOLL Manufacturing will monitor and analyze its complaint and service data files on a monthly basis to identify the need for formal CAPA investigations into reported problems. The CAPA investigation may be assigned to design engineering, manufacturing engineering, quality engineering, or regulatory affairs engineering. When an analysis of the data, performed by Regulatory Affairs, identifies the need for a formal investigation, Regulatory Affairs is responsible for coordinating the generation of a formal CAPA. In the event Regulatory Affairs makes the decision not to initiate a CAPA, the rationale shall be documented.

There are two independent methods of analysis: the Rate Method and the Risk Ranking Method. The Rate Method is applied to both the complaint and service data to perform this analysis. The Risk Ranking Method is also applied to complaint data, specifically to reported problems, to perform this analysis. All rates defined below are normalized based on patient days of use since the LifeVest system is a continuous monitoring system.

The results of the two methods of analysis will undergo further evaluation using SPC (Statistical Process Control) and a subsequent failure mode review, as required (See Section 5.3.3).

5.3.1 Rate Method

The methodology for the rate based analysis is modeled after the International Medical Device Regulators Forum (IMDRF) guidance document GHTF/SG2/N54R8:2006, in which an upper limit threshold is established based on the baseline rate, changes in rate are monitored, and investigations are initiated when the rate exceeds the upper limit threshold.

ZOLL Manufacturing will use the following formula to identify a change in rate that indicates the need for further evaluation to determine the need for a formal investigation.

> IB (IB > 0) and > IT

A Baseline incident rate (IB) and Threshold incident rate (IT) is compared to the


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rate of each reported problem in any given month. (IT) is a biased weighted rate for each reported problem in the preceding 3 and 6 months which facilitates the timely detection of a potential problem where the rate is increasing month over month. This formula is described in detail below.

1. The rate of each reported problem is established for the month under evaluation

2. The average rate of each reported problem is established for the preceding 3 months prior to the month under evaluation

∑

3

3. The 3-Sigma upper control limit (UCL) of each reported problem is established for the preceding 3 months prior to the month under evaluation

3 ∗

where, is the standard deviation of the rate of each reported problem for the preceding 3 months prior to the month under evaluation.

4. The average rate of each reported problem is established for the preceding 6 months prior to the month under evaluation

∑

6

5. The 3-Sigma upper control limit (UCL) of each reported problem is established for the preceding 6 months prior to the month under evaluation

3 ∗

where, is the standard deviation of the rate of each reported problem for the preceding 6 months prior to the month under evaluation.

6. The Baseline incident rate (IB) is then calculated as follows:

0.5 ∗ 0.5 ∗

Note: IB is an equally weighted rate for each reported problem in the preceding 3 and 6 months in order to provide an equal emphasis.

7. The Threshold incident rate (IT) is then calculated as follows:

0.2 ∗ 0.8 ∗

*Note: Zero data points are excluded in the above computations.


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5.3.2 Risk Ranking Method

The risk ranking method will identify the need for a formal investigation based on Severity and Occurrence Level of the reported problem codes in any given month.

Severity is an assessment of the seriousness of the effect of the reported problem and impact on the devices ability to perform its essential function. The essential function of the LifeVest is to appropriately detect treatable life-threatening arrhythmias and to administer an appropriate shock to treat the user. A severity ranking will be assigned to each of the reported problem codes on a scale of 1 to 5 per SOP 90C0014.

The Occurrence Level is an integer value corresponding to the rate of the reported problem. This integer value is ranked on a scale of 1 to 5 per SOP 90C0014.

, ,

where, , , are the corresponding rates of each reported problem in each of the preceding 3 months prior to the month under evaluation.

Risk Rank Value (SOL)

∗

An SOL >=8 indicates the need for further evaluation to determine the need for a formal investigation as shown in the table below.

RISK RANK Severity Level

1 2 3 4 5

Occurrence Level S O L

1

S

O

L

1 2 3 4 5

2 2 4 6 8 10

3 3 6 9 12 15

4 4 8 12 16 20

5 5 10 15 20 25

Does not trigger the need for further evaluation for SOL values < 8.

Triggers the need for further evaluation for SOL values >= 8.

5.3.3 SPC Evaluation

RA will evaluate the results of the Rate Method and Risk Ranking Method analyses using SPC when determining the need for a formal investigation. The SPC evaluation will utilize rates from the month under review and preceding 11 months.

OL SL


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If the SPC evaluation indicates any one of the following four criteria, a Failure Mode Review (See Section 5.3.4) shall be performed. The four criteria are:

The current rate is above the upper control limit The current and preceding 1 month’s rates are above the two sigma limit The current and preceding 3 months’ rates are above the one sigma limit The current and preceding 7 months’ rates are above the average

If the above SPC criteria are not met, the SPC evaluation indicates that the current failure rate is statistically consistent within the 12 month analytical period and as such, does not require a formal investigation.

5.3.4 Failure Mode Review

If the results of the SPC Evaluation meet any of the criteria listed in Section 5.3.3, RA shall perform a Failure Mode Review. The details of the associated complaint or service records are reviewed to confirm the increased trend is attributed to a common failure mode. If confirmed, a formal investigation is required.

5.4 Management Review

Management, with executive responsibility, reviews all sources of quality data serving the CAPA process in accordance with SOP 90E0492.


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Internal C/A Flowchart


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Supplier C/A Flowchart

Internal analysis, disposition, review, or observation

identifies need for Supplier Corrective/Preventative Action

SQE initiates SCAR form & enters in SCAR Log

Supplier determines correction, root cause and

corrective action

Response forwarded to QA within 30 days?

SQE notifies Supplier

SQE evaluates effectiveness of C/A or

P/A

SQE closes SCAR and updates SCAR log

SCAR forwarded to Supplier’s authorized

representative

Response acceptable?

Supplier determines correction, root cause and corrective action

SQE updates SCAR Log & establishes planned

effectiveness review date

Effective?

New SCAR initiated and entered in log. SQE closes original SCAR and updates

SCAR Log

No

No

No

Yes

Yes

Yes

Issue Date: Due Date: Responsible Group/Department:

Description of Discrepancy:

ZOLL QA Manager:

Correction:

Root Cause:

Corrective Action:

Projected Completion Date:

Resp. Manager Signature: Date:

Proposed C/A – P/A:

Acpt Rej

C/A Reviewed By: Date: Scheduled Effectiveness Review Date:

C/A – P/A Effective?

Yes No

Briefly describe objective evidence used to determine effectiveness:

Effectiveness Reviewed By: Date:

ZOLL QA Manager Signature: Date Closed:

Definitions: Correction: Is any action that is taken immediately to eliminate a nonconformity or undesirable situation that exists on paper and/or product. Examples of corrections include, but not limited to, rework, repair, resort, reprocess, or scrap. However, corrections do not address causes. Root Cause: Is identifying the actual base level event that built into a set of events leading to the nonconformity or undesirable situation. Several tools exist to perform an effective root cause analysis. One tool is the “5 Why” set of questions. By repeatedly asking the question “Why” (five is a good rule of thumb), you can peel away the layers of symptoms which can lead to the root cause of a problem. Very often the ostensible reason for a problem will lead you to another question. Although this technique is called “5 Whys,” you may find that you will need to ask the question fewer or more times than five before you find the issue related to a problem. Corrective Action: Is any action taken to remove the causes of an existing nonconformity or undesirable situation. The corrective action process is designed to prevent the recurrence of nonconformities or undesirable situations. It tries to make sure that existing nonconformities and situations don’t happen again. It tries to prevent recurrence by eliminating causes. Corrective actions address actual problems. Because of this, the corrective action process can be thought of as a problem solving process. To propose and implement an effective corrective action, the root cause must be identified.

ZOLL Form Number: 90C0010-A01 Form REV Level: D

ZOLL Corrective Action Request CAR Number:

Supplier Name:

ZOLL Part Number: PO Number:

Issue Date: Response Due Date:

Description of Discrepancy:

ZOLL SQE Manager: ZOLL Purch or Matl’s Mgr:

Correction: (To be completed by Supplier)

Root Cause: (To be completed by Supplier)

Corrective Action: (To be completed by Supplier)

Projected Completion Date:

Supplier’s Authorized Signature: Date:

Title:

Proposed C/A – P/A:

Acpt Rej

C/A Reviewed By: Date: Scheduled Effectiveness Review Date:

C/A – P/A Effective?

Yes No

Briefly describe objective evidence used to determine effectiveness:

Effectiveness Reviewed By: Date:

ZOLL SQE Manager Signature: Date Closed:

Definitions: Correction: Is any action that is taken immediately to eliminate a nonconformity or undesirable situation that exists on paper and/or product. Examples of corrections include, but not limited to, rework, repair, resort, reprocess, or scrap. However, corrections do not address causes. Root Cause: Is identifying the actual base level event that built into a set of events leading to the nonconformity or undesirable situation. Several tools exist to perform an effective root cause analysis. One tool is the “5 Why” set of questions. By repeatedly asking the question “Why” (five is a good rule of thumb), you can peel away the layers of symptoms which can lead to the root cause of a problem. Very often the ostensible reason for a problem will lead you to another question. Although this technique is called “5 Whys,” you may find that you will need to ask the question fewer or more times than five before you find the issue related to a problem. Corrective Action: Is any action taken to remove the causes of an existing nonconformity or undesirable situation. The corrective action process is designed to prevent the recurrence of nonconformities or undesirable situations. It tries to make sure that existing nonconformities and situations don’t happen again. It tries to prevent recurrence by eliminating causes. Corrective actions address actual problems. Because of this, the corrective action process can be thought of as a problem solving process. To propose and implement an effective corrective action, the root cause must be identified.

ZOLL Form Number: 90C0010-A02 Form REV Level: E

ZOLL Supplier Corrective Action Request SCAR Number:

CAR Number

Issue Date

Due Date

Area Requiring Corrective Action

Resp Group/Dept

Date Acpt Resp

Rec’d

Scheduled Effectiveness Review Date

Effectiveness Review Date

Date

Closed

ZOLL Form Number: 90C0010-A03 Form REV Level: B

Corrective Action Request Log

CAR Number

Issue Date

Due Date

Area Requiring Corrective Action

Supplier

Date Acpt Resp

Rec’d

Scheduled Effectiveness Review Date

Effectiveness Review Date

Date

Closed

ZOLL Form Number: 90C0010-A04

Form REV Level: B

Supplier Corrective Action Request Log

Documents

DOCUMENT REVISION HISTORY PAGE - …documents.dmetrain.com/custom/1542/courses/Z90c0010/90c0010_rev… · DOCUMENT REVISION HISTORY PAGE ... Clarified scope of SOP. ... GHTF/SG2/N54R8:2006