Capa Ul
Capa Ul
The Client requested your participation in the Corrective and Preventive Action process via the online
CAPA system at clientportal.ul.com. The CAPA website will allow you to automate the corrective
action process and provides real time access to audit data and associated interactions with the
Approver (Client or UL on behalf of the Client). This document provides you with information on how
to use the CAPA website, and also provides information on how to create strong responses to non-
compliance issues to submit through the CAPA system.
Responder = Facility
Responder/Reviewer = Vendor (only if applicable)
Approver = Client or UL on behalf of the Client
Upon completion of the audit, any non-compliance findings are transmitted to the CAPA system.
Each facility and Vendor provides an email address for the designated individual(s) handling the
CAPA responses:
This person is ultimately responsible for submitting responses with regards to non-compliance
findings within their level of the supply chain.
This person should be someone employed directly by either the facility or the vendor.
This person should not be an agent, middleman or someone outside the specified supply chain.
This person will receive an email notification when new CAPA items are waiting for their response;
as well as their current escalation status. In this email a link is provided to access the system.
The first time the system is accessed the main contact will register with a new original password.
A single assessment may generate multiple CAPAs according to the non-conformances found during
the audit.
The CAPA tool will help you to:
Facility Roles
First CAPA Response CAPA Response Revisions
• Review findings • Respond to any CAPA plans returned by Vendor
• Submit CAPA plan up to Vendor or Client
• Upload evidence • Submit CAPA plan up to Vendor
• Make improvements
Vendors should communicate with their facility staff about how they will address compliance findings.
For each CAPA finding the facility will be asked to provide information including:
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Correction / Immediate Action
o The short-term action taken instantly to reduce risks posed to workers. This is the action
that you will take to immediately correct or remediate the finding.
Root Cause
o There is a problem in the current system. Root Cause is the earliest cause that leads to
a non-compliance. By asking yourself a series of questions related to the points below,
you can adopt some methods to identify the root cause of your non-compliance issue:
o First, identify if there are sufficient policies or procedures to make sure the system
meets both local regulations and the Clients’ requirements. If you don’t have a policy,
then that would most likely be your Root Cause. If your company does have a policy in
place, you will likely need to dig deeper by asking yourself questions like: Do you have a
good communication system to ensure workers were adequately trained on this
requirement? Do you monitor and track implementation of that training for those
employees? Once you’ve identified the root cause, you can develop a plan to prevent
the non-compliance issue from occurring again.
Corrective Action
o Even if you have corrected the finding with the Correction/Immediate Action, you will still
be required to submit a Corrective Action in order to prevent the re-occurrence of the
non-compliance through long-term systemic changes. The five components listed below
should be based on the root cause(s) for the non-compliance you identified above.
- Policies & Procedures: Based on your root cause analysis in the previous step,
what policies or procedures should you have in place to prevent these findings
from occurring again? Who will be involved in drafting them?
- Communication: Once you have developed your policy and procedure, how will
you communicate these policies to managers and employees? Also, how will you
communicate these policies and procedures to new hires who have recently
started working at your facility?
- Training & Skills: Do your staff and managers have the skills/experience to
carry out these new policies? Do they need additional training? How will you train
them on these new procedures and how often will you conduct those trainings?
Will additional external training be provided?
- Monitoring & Tracking: Checking that the system is actually effective. What
system will you put in place to monitor that your new policy/system is working
and being properly maintained? For example: internal audit, regular inspection,
or document and record tracking? Please include details about frequency of
internal audits or inspections, etc.
Responder Comments
o Any additional information the approver should know
Evidence
o The CAPA Approver may request the following supporting documents to verify
corrective actions:
Copy of the updated policy/procedure;
Proof of training on updated policy
• Training materials
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• 3 photos of training session
• Training records signed
Implementation photos:
• Minimum of 3 corrected photos
The self-inspection and/or maintenance documents.
For CAPA Items that have been successfully submitted to the system for approval, the status listed
under the CAPA Item Status field will change to “Pending Approval” and an email notification will be
sent to the CAPA Approver notifying them that they have an item to review.
NOTE: Please do not contact UL via email to ask for confirmation that your CAPA was successfully
submitted to the system as the status change to Pending Approval will already indicate that your
information was successfully submitted.
Once a CAPA response is submitted, the Approver will accept or reject the CAPA Response. If the
response is incomplete, the facility and vendor will receive an email asking for more information.
If a response is rejected there will be Approver Comments that describe the reason it was rejected
and the additional information necessary to have the response approved. To achieve CAPA item
approval, ensure that you have carefully read the Approver Comments and that the Approver’s
recommendations are followed by the facility and vendor.
If a response is accepted, the status of the non-compliance will change to ‘Approved’ and no further
action is required. Also, depending on the nature of the non-compliance issue, the status of some
items may be transitioned into the ‘Pending Onsite Verification’ status as an onsite verification is the
only way to successfully close out some non-compliance issues.
For each CAPA item, the CAPA Responder is allowed three (3) attempts to respond (unless
specified otherwise by the Client). If a CAPA response is rejected three times this will typically
result in a follow-up audit which will be decided by the Client.
Correction/Immediate Action
The leadership paid particular attention to excessive overtime problem, had
convene a corrective action meeting on 2015-8-26. The conclusion was that factory
could not completely compliance with 628h requirement, each department would
take continue improvement, to reduce the excessive overtime problem from 70% to
50% in 3 months.
Root Cause
The root cause was: 1.there was not enough intensity of supervision for excessive
overtime; 2. some seasons had much indents that cause excessive overtime
Corrective Action
1. Policies & Procedures: The meeting on 8/26 had further defined the
responsible person for compilation, update, implement of "employee manual" and
"Production planning regulations". Further learned the "Allow enterprises shall
practice a system of other work time resolution paper"
3. Training & Skills: HR will provide training for all administrative staffs and
employees. Production Dep. will train manufacturing workers and HR will train the
administrative staffs from each Dep.to make sure that each staff understand the
overtime requirement from customers and low, and understand how to control with
the excessive overtime, it will also to make sure that each employee understand
the internal overtime requirement and strictly enforce.
Correction/Immediate Action
All the roller-shutter doors will be replaced with side-hinged doors.
Root Cause
The root cause was lack of awareness that all exit doors shall open outward in the
evacuation
Direction as part of fire safety requirement.
Corrective Action
1. Policies & Procedures: The factory will replace all roller-shutter doors with side-
hinged doors opening outwards. They will communicate to all employees the reason
of this change with a temporary memo on the notification board.
3. Training & Skills: The person in charge has enough skill to address this issue
and contact a hardware worker to make sure that the doors are replaced and work
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without problem. This policy will be explained in verbal and in writing to each person,
making sure to explain the reason why
The factory needs to use side-hinge doors instead of rolling doors. If this person is
replaced, this and all security policies will be explained in verbal and in writing to the
new replacement making sure that the awareness of this security issue is not lost on
the transition. Now that the facility understands this security issue and all doors are
being replaced, we consider redundant to train and explain this policy to the same
person on a weekly, monthly or yearly basis, but the facility will have periodic
reviews (perhaps every 6 months) to review safety issues.
4. Monitoring& Tracking: All doors will be checked and recorded with a picture.
These pictures will be used for CAPA and also for internal records and available for
future references. The mere fact that all evacuation doors are now side-hinged it's
enough to consider this policy to be implemented successfully. We consider
redundant to check that all doors are side-hinged on a daily, weekly or monthly
basis. Nobody will tear down the newly installed doors.
Comment:
-Immediate Action is ACCEPTED;
-Root Cause is INCOMPLETE and must be revised;
-Corrective Action is INCOMPLETE and must be revised.
Comment:
-Immediate Action is ACCEPTED;
-Root Cause is INCOMPLETE and must be revised;
-Corrective Action is INCOMPLETE and must be revised.
3. Corrective Action does not include all 5 points (Policies & Procedures, Communication,
Training & Skills, Monitoring & Tracking, and Governance & Enforcement)
Comment:
-Immediate Action is ACCEPTED;
-Root Cause is INCOMPLETE and must be revised;
-Corrective Action is INCOMPLETE and must be revised.
Comment:
-Immediate Action is ACCEPTED;
-Root Cause is INCOMPLETE and must be revised;
-Corrective Action is INCOMPLETE and must be revised.
In the example above, this factory states that they were informed by the local fire department that their
plant is not required to have a Fire certificate. In this scenario, the factory is advised to communicate
directly with the client (especially if the assertion is that no corrective action is needed). A decision
about how to proceed with that particular CAPA item and whether or not a CAPA plan is still required
will then be at the Client’s discretion. Otherwise, without the client’s approval, a complete CAPA plan
will still be required for any item listed in the CAPA system.
Comment:
-Immediate Action is INCOMPLETE and must be revised;
-Root Cause is INCOMPLETE and must be revised;
-Corrective Action is INCOMPLETE and must be revised.
NOTE: If multiple findings have the same CAPA responses, you can
check the boxes next to the CAPA items and click ‘edit’.
Screens will look slightly different but the process and steps are
the same.
8) Click submit. If you click save and close, it will take you back to the
dashboard screen. From here, you can check the box next to
the CAPA item(s) you want to submit; and then click ‘submit’ to
finalize the multiple CAPA items at the same time.
If you run out of room when responding in any cell, you can add
additional information in the Responder Comments box.
• Correction/Immediate Action
• Root Cause
• Corrective Action
• Remediation Completion Date
Vendor Roles
First CAPA Response CAPA Response Revisions
• Review findings • Return CAPA plan back to facility with comments
• Review Facility’s CAPA plan • Review any resubmitted plans and submit to
• Submit CAPA plan up to Client Client
• Respond to any CAPA plans returned by Client
Click on Item
Information.
To return an insufficient
response back to a
facility for review and
edit, click Return to
Submitter and follow
prompts. NOTE:
During prompts, you will
be asked to add a
comment. Any
comment you add will
automatically be saved
as a responder
comment.
5) If the response
submitted by the facility
is sufficient but you as
the vendor have
additional comments,
you can add these
comments in the
Responder Comments
field by clicking the Add
Responder Comments
tab and then following
the prompts.
Sending Emails from the CAPA System (From Summary or Item View)
Click on “Add
Recipients.”
5) Add attachments as
needed.
To add attachments,
click “Select” in lower
right hand corner.
Follow prompts to
open/attach desired
document.
Click OK on bottom of
pop up box.
REFERENCE INFORMATION
**Please refer to the section titled CAPA Summary Status versus CAPA Item Status on page 20
for detailed explanation about statuses at the Summary or Item level.**
Responder = Facility
Responder/Reviewer = Vendor (only if applicable)
Approver = Client or UL on behalf of the Client
Escalation Definitions
Actions that will reset the Escalation level back to green include:
• Submit
• Approve
• Return to Submitter
• Pending Onsite Verification
• Close
• Reopen
Escalation Levels are set weekly and a Weekly Email is distributed as follows:
• After the completion of California’s work day (After 3:00 AM EST)
• Before Asia's Monday work day start (3:00 AM Sunday EST)
The CAPA Summary Status indicates the stage of the CAPA process based on a cumulative analysis
of all CAPA’s for a particular facility or vendor. It is updated to reflect the item status with the least
progress, or in other words, the status reflecting the item that is in the earliest phase of the CAPA
process. Note that there are two ways to view this information: the CAPA Summary View, and the
CAPA Items View. Please see detailed descriptions of each view below:
Clicking on the Green, Yellow, or Red status columns, or clicking on any individual number listed in
the matrix under those columns will filter the results displayed in the Summary View field on the right
to display only those CAPA Summary numbers relevant to that particular status.
For example, by clicking on the number “1” directly under the Yellow status in the screenshot below,
we are able to pull up the one factory that is under the Yellow status and that is Pending Initial
Response.
Note: If there are two CAPA items for one facility and one CAPA is “Pending Initial Response” while
the other is “Pending Approval”, the overall CAPA Summary Status for that facility will be “Pending
Initial Response” as this is the CAPA Item Status that reflects the least progress.
To switch back to CAPA SUMMARY View from the CAPA ITEMS View:
When in the CAPA Item view, click on the words “Show Summary View” under CAPA Items in the top
left corner of the page:
If a contact’s email
address is spelled
incorrectly, the correct
contact is not listed, or
a contact’s email
address needs to be
updated entirely, please
contact
[email protected].
Every time an item is modified in the CAPA system, an automatic email called the CAPA Daily
Action Summary is generated to CAPA users. Without having to log into the system, this email will
help you see if any new Items are pending your response.
Please be sure to add [email protected] to your address book so these emails do not go to
your Spam Folder.
The CAPA Daily Email contains a spreadsheet of all the CAPA summary status activity for the day.
Export Findings
It may be convenient for you to download all finding information and Approver Comments in an easy
to read excel format that can be reviewed when you are logged off the CAPA system.
• Make sure that you are in Item View before exporting all of your findings.
• From the Item View click Export to Excel at the bottom of the screen (see red arrow in screen
shot).
• A pop-up window will open and you will then need to choose which fields you would like to
include in your export:
• After the audit, the factory and/or vendor contact information will be requested. The provided
email address(es) will be used as the user ID to sign into the portal.
• Go to clientportal.ul.com and enter your email address in the Username field. Click the
“Forgot your password?” link on the login page.
• The system will automatically send you an e-mail with a temporary password. The e-mail
address that receives the e-mail with the temporary password is your user ID (e.g.
[email protected]).
• Once you login, you will be asked to change your password.
• Create a password that you will be able to remember, and keep it in a secure location. Do
not include any spaces before or after the temporary password that you enter, and check
that you do not have ‘Caps Lock’ on.
• If you receive the message “The entered user name was not found” when you submit a
request to reset your password, you have either entered the incorrect e-mail address, you
have not yet been given access, or an incorrect email address was supplied at the time of
the audit. In this case, contact the UL CAPA managed team ([email protected]) or your UL
Client Service Manager for further support.
• Create a password that you will be able to remember, and keep it in a secure location. Do
not include any spaces before or after the temporary password that you enter, and check
that you do not have ‘Caps Lock’ on.
• If the previous person responsible for entering CAPA responses is no longer with your
company and that person’s email address is no longer valid, you will not be able to use the
reset password feature. In this case, please contact a system administrator at
[email protected]
Issue: I get an error message when I log-in and can’t access the system.
If you cannot access the system or login page at all, first contact your Client Service Manager to
verify that UL has created a user ID for you. If an ID has been created, and you are still unable
to access the system, you may be able to resolve the issue with one of the following
approaches:
You can download Microsoft Internet Explorer via the following link:
http://windows.microsoft.com/en-US/internet-explorer/downloads/ie
The UL CAPA System uses Microsoft Silverlight, a plug-in which is widely accepted by most
major internet browsers. This plug-in feature sometimes needs to be updated or added to your
browser.
You can download Microsoft Silverlight directly via the following link:
http://www.microsoft.com/getsilverlight/Get-Started/Install/Default.aspx
Firefox: http://www.mozilla.org/en-US/firefox/new/
For guidance on enabling cookies, click the link below or visit the Help feature on your internet
browser:
http://windows.microsoft.com/en-us/windows-vista/block-or-allow-cookies
• If the time does not match, then you will need to update your computer’s clock to match the
time stated on Google.
• If your computer is set on a different time zone, then you will need to update your computer’s
clock to match the local time in the time zone where you are.
Please find this link to view the training video (It requires you to log-in to your account to
access the video: CAPA Training Video
Contact Information
UL Contact (Audit and CAPA access or error questions; CAPA response questions)