Facility & Monitoring Firm Guide to: Online Corrective and

Facility & Monitoring Firm

Guide to: Online Corrective and Preventative

Action (CAPA) Process

Issued January 22, 2015 Prepared by: ISS Program Management

Revision: v. 3.0 Authorized by: Director, Supplier Workplace Accountability

Replaces: 2.2 Worldwide Supply Chain Management

Page 2 of 21 File Name: Combined CAPA Guide for Facilities and Monitoring Firms

Table of Contents Introduction ..............................................................................................................................................3

Section A: Facility Guide: Online CAPA Submission Process .......................................................4

Section B: Monitoring Firm Guide: Online CAPA Review Process .......................................... 13

Appendix ................................................................................................................................................. 21

Acronyms:

Monitoring Firms (MF)

Program Manager (PM)

Corrective and Preventative Action Plan (CAPA)

For technical support issues contact [email protected]

mailto:[email protected]





Introduction

The purpose of this document is to provide instructions on how to submit a Corrective and Preventative Action Plan (CAPA) via iEnable. The CAPA process has been developed to enable documentation and tracking of each corrective action including monitoring firm feedback which may be used during follow-up audits. A summary of the process is outlined below:





Section A: Facility Guide: Online CAPA Submission Process For each CAPA submission the monitoring firm will evaluate the proposed action for the following components (See Appendix for more information):

Immediate Corrective Action Root Cause Long Term Preventative Action Preventative Action Team

The CAPA process is not considered as confirmation of actions taken or issues closed, verification of the actions will occur during the next onsite audit/ assessment. The CAPA may be completed by the facility in local language however if local language is used, the reviewer comments must also be in English.

I. Notification Within 24 hours of the audit report being finalized the facility will receive a notification (example below) from iEnable regarding the CAPA process and requirements.

From: iEnable – Intertek

Sent: Friday, February 07, 2014

To: Facility/MF/PM

Subject: Corrective Actions Due by March 7, 2014

07-Feb-2014

Good Food Facility – West Memphis, IL

Dear All,

Thank you for your on-going commitment to continuous improvement as a supplier to McDonald’s. As part of the enhanced Supplier Workplace Accountability (SWA)

program features an online CAPA is available for your submission. Your Corrective and Preventative Action Plans (CAPA) for any gaps identified during your recent

on-site assessment may now be completed in iEnable. A guideline for this feature is attached to this email.

Please note your Corrective and Preventative Action Plan (CAPA) submission is due by March 7, 2014. Thank you for your attention to this deadline. If you have any

questions or concerns related to the submission of your corrective actions please contact your Program Manager as below:

[email protected]

Note: The monitoring firm is reviewing for… completeness of plan the response is reasonable and considers the root cause of the non-compliance timely implementation of actions






II. How to access the CAPA

Step 1: Log on to iEnable at https://ienable.intertekconnect.com to see your “Self Service Portal”

(pictured below). Select the Corrective Actions button as shown.

Step 2: Once you have selected the green Corrective Actions Button, you will see the window below.

Click on the ‘+’ icon to view your list of findings and begin the CAPA process.

https://ienable.intertekconnect.com/





Helpful Tool Tip

Data Export: You can export the findings to Excel for easier internal review. The details will be exported as shown here …

Step 3: On the ‘Corrective Actions’ page under the column labelled ‘Finding Number’, click on the “Pencil” icon to view further details of each finding.





Helpful Tool Tip

Although not a requirement, there may be instances where it is helpful to upload a document and/ or photo to address the finding and provide better clarity of the Corrective Action. (*File Size Limit: 4 MB No videos, must be document or picture) Uploading Attachments From the same view in Step 3, scroll to the bottom of the page… Select ‘Upload File(s) to address Findings’ (green button).

Upload the appropriate document (Browse)

Select corresponding finding(s) (Under item use the drop down menu item.)





Step 4: Once you are on the “Manage Corrective Actions” page (viewing an individual finding), select the ‘Auditor’s Findings’ tab. You will see each finding pre-populated with the “Applicable Law/ Customer Expectation” and the text of the finding as issued on the final audit summary.

Note: If a finding was corrected onsite it will auto-populate into the CAPA as shown in the example

below, however all sections still need to be completed:





Step 5: Next, click on the “Corrective Action” tab to begin completing in your CAPA plan.

Note: All sections are required fields as indicated by the RED left border of each text box. You will not be able to submit your CAPA unless ALL fields are completed for ALL findings. The MF will accept individual findings and provide feedback, sending back only those which require additional information.

Step 6: When you finish working in each section be sure to SAVE YOUR WORK.

Click the ‘Save and Close’ button to close out and return later.





Helpful Tool Tip

Jump to Finding: Use ‘Next Corrective Action’ button to work through each finding chronologically. Use the ‘Jump to Finding’ drop down menu to work in any order. The drop down menu under ‘Jump to Finding’ also identifies the status of each finding, i.e. ready to submit, pending facility review etc.

Step 7: Once you have completed a CAPA and are ready to submit for review, click ‘Submit to Auditor’. You will need to complete this step for EACH FINDING (including any corrected during the audit). The drop down menu under ‘Jump to Finding’ is an easy way to view status of each finding.

Important: When you have completed your last CAPA you MUST click “Submit to Auditor” to finish the process.





STEP 8: Once you have completed the CAPA for each finding and have clicked ‘Submit to Auditor’ for each finding you will receive the pop-up message below.

Once you select ‘OK’ an email notification from iEnable will be automatically generated. You may edit the message and/ or add additional email recipients prior to sending the notification.

NOTE: If the email notification does not load immediately DO NOT click again or the notification will no longer be accessible.

The Monitoring Firm Reviewer has the same email option when reviewing the CAPA submission so you will receive an email response as applicable.





III. Tracking Progress Once submitted, the ‘Status’ column on your Corrective Action tab will automatically update as you work through the stages of the process.

The following are the options:

If the monitoring firm “Accepts” the submitted CAPA plan – it will indicate this on iEnable and close the CAPA process - the status will change to “Accepted”

If there is not enough information or that the information you provided is not clear the monitoring firm will return the CAPA with comments - an email indicating this action will be sent.

Note: After the 3rd request for more detail by the monitoring firm, the information has not been finalised, the monitoring firm will close out the CAPA with a “Not Accepted” status which will be further reviewed by McDonald’s AOW Lead.

Important Points:

Due date is 30 days after receiving final audit summary

The CAPA must be submitted via iEnable (NOT directly to the Program Manager)

Monitoring Firm has 5 business days to review CAPAs (after each of the 3 submissions)

Feedback will be provided via automatic emails throughout the process

CAPA will be reviewed a maximum of 3 times by monitoring firm

Facility may complete the CAPA plan in their local language, (monitoring firm to include feedback also in English)





Section B: Monitoring Firm Guide: Online CAPA Review Process For each CAPA submission the monitoring firm designated Reviewer is to evaluate the following components (See Appendix for more information):

Immediate Corrective Action Root Cause Long Term Preventative Action Preventative Action Team

I. Notification of pending CAPA for review The auditor and the monitoring firm QA (as assigned to the audit) will receive an automated

notification from iEnable that pending CAPAs are ready for review. The same email will be sent to

the facility, which includes this document as an attachment.

The CAPA reviewer may be different from the Report QA reviewer, however if the monitoring firm QA will not be the CAPA reviewer the MF will need to forward the notification message (example below) to the selected CAPA reviewer notifying them the CAPA is ready for review.

From: iEnable – Intertek

Sent: Friday, February 07, 2014

To: Facility/MF/PM

Subject: Corrective Actions Due by March 7, 2014

07-Feb-2014

Good Food Facility – West Memphis, IL

Dear All,

Thank you for your on-going commitment to continuous improvement as a supplier to McDonald’s. As part of the enhanced Supplier Workplace

Accountability (SWA) program features an online CAPA is available for your submission. Your Corrective and Preventative Action Plans (CAPA)

for any gaps identified during your recent on-site assessment may now be completed in iEnable. A guideline for this feature is attached to this

email.

Please note your Corrective and Preventative Action Plan (CAPA) submission is due by March 7, 2014. Thank you for your attention to this

deadline. If you have any questions or concerns related to the submission of your corrective actions please contact your Program Manager as

listed below:

[email protected]






II. How to Search for CAPA’s pending MF review: Step 1: Log into https://ienable.intertekconnect.com

From ‘Site Navigation’ on the left side bar and select “Search Assessments” From the “Search Assessments” view, select:

Customer: McDonald’s Audit Main Type: Corporate Social Responsibility Audit Sub-type: SWA CAPA Audit Audit Status: 22. Corrective Action Approval/Acceptance Pending

To view and/or complete corrective actions, click on the “paper icon” to the left of the yellow flag*

*The color of the flag icon indicates different status levels

Step 2: This will open up the Audit Record Information view. You can see the facility’s “Due Date” for submitting the online CAPA. Click on the “Corrective Actions Tab”

https://ienable.intertekconnect.com/





III. How to Review and complete the submitted corrections:

Step 1: From the ‘Corrective Actions’ tab view, click on the “pencil icon” to open the CAPA; ‘Manage Corrective Actions’ will appear with three tabs:

o Auditor’s Findings: findings/ non-compliance as per audit summary o Corrective Action: Corrective Action submitted by the facility (refer to the Introduction and

“Components of a CAPA” page 5) o Reviewer Comments: Added by the reviewer which includes if CAPA is accepted, more info

requested or other comments for the facility to be made aware of.

Note: The “Auditor’s Findings” are the same as what was written on the final audit summary. Status of the CAPA can be viewed as indicate below.

Step 2: After reviewing each CAPA, the MF Reviewer will open the ‘Reviewer Comments’ tab and note that the CAPA has been “accepted” or identifies what additional information is to be considered. The reviewer MUST write a comment in the “Reviewer Comments” box in order to finish the review. Though not required, the facility can choose to upload a photo or document to provide better clarity for the corrective action. This document can be reviewed by clicking on the attachment link found on the ‘Corrective Actions’ tab view:





NOTE: By clicking on the icon the reviewer can view the dates and timelines which is a record of the first and second submissions (this information is automatically tracked by the system).

Step 3: When reviewer’s comments have been completed (see below), refer to the ‘Change Status’ selection of radio buttons to indicate the appropriate status change (i.e. “needs further review” or “accepted”. Note: The “no change” button is only used when reading without making comments what has been completed and you do not need to make changes.)

WARNING!!

**Do not select the “Not Accepted” radio button unless it is the 3rd submission. This will finalize the CAPA as ‘Not Accepted’ and no further actions can take place.





When finished in each section, be sure and SAVE YOUR WORK:

Click Save if you wish to use the top screen navigation to go on to the next finding

Click Save and Close to save and close the view (brings you back to the main screen) Step 4: To navigate to the next Corrective Action for review, click the left or right arrow at the top of the screen to move to the previous or next Corrective Action. You may also use the ‘Jump to’ drop down box in the centre at the top of the screen to bring up the entire list of Corrective Actions.

Step 5: After reviewing the findings, if any are noted as ‘need further review’, be sure to include comments to explain why they require further review. Click ‘Send Back to Facility’ which will generate an automatic email from iEnable. (The MF reviewer has 5 days to review each submission)

Note: iEnable tracks the “Number of CAPA Submissions” and the “Review Dates”





Step 6: Closing out CAPA Each CAPA may be reviewed a maximum of 3 times, after which one of the following should occur:

CAPA meets expectations: Select ‘Accepted’ Then select ‘Corrective Action Complete’ to finalize the CAPA. This needs to be done for

each corrective action.

CAPA does not meet expectations: Select “Not Accepted” on specific finding Provide detail in ‘Reviewer’s Comments’ section (if CAPA in local language, include these

comments also in English) as to why it was not accepted. Click the ‘Corrective Action Complete’ button to close out the process.





Note: There may be a mix of Accepted and Not Accepted in final submission.

Once the CAPA is submitted a warning response will appear. Click ‘OK’.





STEP 7: After clicking ‘OK’, iEnable will generate an email to the facility. The message can be edited and/or recipients added prior to selecting ‘Send Notification and Continue’ button. The appropriate email will generate depending on whether or not the CAPA was ‘accepted’ or ‘not accepted’ REMEMBER: If the CAPA was NOT accepted, copy ISS PM on email.

Important Points:

Due date is 30 days after facility receives final audit summary

All steps within the CAPA process will be via iEnable (NOT via the Program Manager)

Monitoring Firm has 5 business days to review CAPAs (after each of the 3 submissions)

Feedback will be provided via automatic emails throughout the process

CAPA will be reviewed a maximum of 3 times by monitoring firm

MF to follow up once on due date if not submitted

Facility may complete the CAPA plan in their local language, however all MF reviewer comments must also be in English

For technical support contact [email protected]






Appendix The Elements of a CAPA include each of the following:

Immediate Corrective Action

Root Cause

Long term Preventative Action

Preventative Action Team/Time Frame

Immediate Corrective Action: Any steps facility staff and managers will take immediately to reduce risk. This is most applicable in situations that represent potential risk of life, injury, or significant risk to the business. In many cases, non-compliance issues may require a more comprehensive assessment of root causes and development of management systems, which require longer term planning and action. In these cases, include short-term actions that will be taken to address risk and improvement.

Root Cause: Describe the earliest cause(s) in the chain of events that lead to the non-compliant finding. This typically includes gaps in management systems such as training, communication, governance, etc. There can often be multiple root causes that can lead to non-compliant findings. This will require discussion of the finding with various facility staff and managers to identify the cause(s).

Long Term Preventative Action: These are steps that facility staff and managers will take to prevent the non-compliance from occurring again in the future. This is different from an Immediate Corrective Action, which may simply be the removal of the practice that caused the non-compliance.

Potentially, ALL of the following areas in a sustainable management system are to be considered to prevent the issue from repeating again in the future:

Policies/Procedures: What policies should be in place to prevent these findings from occurring again? Who will be involved in drafting them?

Communication: How will the facility communicate these policies to facility staff and managers? How will it be communicated to new hires?

Roles and Responsibilities: Who will be responsible for carrying out, communicating and measuring policies? Who, at the management/ownership level, is ultimately responsible for this part of the business?

Capabilities/Training: Do facility staff and managers have the correct skills to carry out new policies? Do they need additional training? Will it be conducted in languages understood by all workers?

Business Integration: How will the business implement policies? How will they be carried out in the day-to-day business?

Monitoring/Internal Verification: How can facility staff and managers ensure policies are being followed and how will they measure success (internal audit program, employee turnover rate, increase/decrease of quality defects)?

Governance/Enforcement: How can facility staff and managers track and manage data to determine any changes based on what was learned?

Grievance Mechanism: How can facility staff and managers receive feedback from workers regarding policies/procedures within the facility? Is it anonymous where allowed by local law?

Preventative Action Team: Indicate the person or persons assigned to complete the Immediate Corrective Actions and the Long Term Preventative Actions. This can include immediate actions, drafting of policies, communication, training, and/or a system to measure success. Include all facility staff and managers who will be responsible for any part of the process.

The verification of the implementation of the corrective actions will occur at the time of the facility’s next onsite audit.

Documents

Facility & Monitoring Firm Guide to: Online Corrective and