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Capa Ul

Guidance to create CAP audit UL

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0% found this document useful (0 votes)
327 views

Capa Ul

Guidance to create CAP audit UL

Uploaded by

aristian27
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 35

Online CAPA (Corrective and Preventative Actions) System

Standard User Guidelines (Version May 2016)


For Supply Chain Organizations

© 2015 UL LLC Page 1 of 35


Table of Contents

OVERVIEW OF THE CAPA PROCESS........................................................................ 3


About Corrective Actions and the CAPA Tool ......................................................... 3
Responding to Non- Compliances in CAPA ............................................................ 3
Actual Examples of Good CAPA Response ............................................................ 6
Top Actual 5 Examples of Bad CAPA Response .................................................... 9
Submitting Results and Adding Evidence ............................................................. 14
Approving Facility Responses as a Vendor ........................................................... 18
Sending Emails from the CAPA System (From Summary or Item View) ............... 20
Using Spell Check ................................................................................................ 22
REFERENCE INFORMATION .................................................................................... 24
Definitions of CAPA Statuses................................................................................ 24
Escalation Definitions............................................................................................ 26
CAPA Summary Status versus CAPA Item Status ................................................ 27
CAPA Email Notifications Overview ...................................................................... 29
Export Findings ..................................................................................................... 30
CAPA Troubleshooting: Log-in Errors ................................................................... 32
Online CAPA Tool Training Video ......................................................................... 35
Contact Information............................................................................................... 35

© 2015 UL LLC Page 2 of 35


OVERVIEW OF THE CAPA PROCESS

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.

About Corrective Actions and the CAPA Tool

There are three key roles for 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:

Track improvements in your factories.


Communicate those improvements to the Client.
Save time in addressing findings from social compliance assessments.
Minimize risk to your business.

Responding to Non- Compliances in CAPA

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:
© 2015 UL LLC Page 3 of 35
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.

© 2015 UL LLC Page 4 of 35


Whether you already have a policy or monitoring procedure in place, please ensure that
information for all five of the below points are included in your corrective action:

- 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.

- Governance & Enforcement:


• Who is the responsible person (position title) for carrying out these
policies? For communicating them? For measuring them? Who at the
Executive/Ownership level is responsible for this part of the business and
how will you ensure that they are doing their job properly? By conducting
an internal audit? Or through Management Review?
• If an issue is found during Monitoring & Tracking, what disciplinary actions
are taken when policies are not being followed?

Remediation Completion Date: for implementing the above


o Ensure this is reasonable and appropriate for the root cause.

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
© 2015 UL LLC Page 5 of 35
• 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.

Please find examples of Good and Bad CAPA Responses Below:

Actual Examples of Good CAPA Response

#1 Working Hours Finding:

© 2015 UL LLC Page 6 of 35


#1 Provided CAPA Plan:

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"

2. Communication: HR will post the "Allow enterprises shall practice a system of


other work time resolution paper" and transmit the meeting minutes to all staffs and
employees.

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.

4. Monitoring& Tracking: Production Dep. will monitor the longest overtime


timeout each month, if it over the allowable overtime timeout, should take corrective
action, to ensure the quarter hours could compliance with requirement. For some
seasons had much more indents, production Dep. should make the manpower
demand plan or arrange workers concentrated rest, rotate days off, take deferred
holidays, to ensure employees' working hours would compliance with requirement.
体系部每月根据考勤记录情况对加班时间进行核实,确保加班时间符合政策规定,
发现有不符合情况,立即出具纠正预防措施,并督促整改和验证结果。社会责任内
部审核,体系部着重对加班超时进行审核评估,确保得到改善和执行。 The system
Dep. will verify the monthly attendance records, to ensure the overtime hours would
compliance with relevant requirement. If find out any incompliance, then take
corrective action immediately, and keep verification result. System Dep. will
seriously assessment the overtime excessive item during internal audit.

© 2015 UL LLC Page 7 of 35


5. Governance& Enforcement: Overtime timeout organization of preventive
measures: overall responsibility for the management representative for overtime
timeout issues. Production Manager is responsible for the implementation of
overtime provisions, HR managers responsible for overtime policy promotion,
training. Systems Department is responsible for the internal audit to verify
employee's actual monthly overtime. Implementation of the result embodied in the
management review report. Production Department, HR\ system monthly reports to
the management representative "overtime provisions" implementation, in order to
take timely measures for improvement.

#2 Health & Safety Finding:

#2 Provided CAPA Plan:

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.

2. Communication: Policy regarding evacuation doors will be printed and placed


near each exit door so everyone will be able to see. This policy will be included in
the basic training for all new hires regardless of the position and working area they
are hired for.

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
© 2015 UL LLC Page 8 of 35
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.

5. Governance& Enforcement: The responsible person for overseeing this issue


will be Mr. ZLL. He will personally review all the doors and record that the changes
are made and that the policies are printed and announced to all personnel.

Top 5 Actual Examples of Bad CAPA Response

1. Only provide Immediate Action in all 3 sections

© 2015 UL LLC Page 9 of 35


Per the above picture, you can see that the three (3) sentences in the “Immediate Action”, “Root
Cause” and “Corrective Action” sections are identical. Please refer to CAPA guidance and note that
the “Root Cause” and “Corrective Action” sections are for root cause analysis and long-term corrective
action respectively. The sentence “provide first aid kit for the kitchen and one 3-floor dormitory building”
can only be considered as an Immediate Action instead of the Root Cause or Corrective Action.

Comment:
-Immediate Action is ACCEPTED;
-Root Cause is INCOMPLETE and must be revised;
-Corrective Action is INCOMPLETE and must be revised.

2. Unclear Root Cause Analysis (Superficial root cause)

© 2015 UL LLC Page 10 of 35


Per the picture above, you can see that the provided root cause is “management oversight” which is
not an acceptable root cause. Please refer to CAPA guidance and note that root cause is the earliest
cause(s) that lead to the non-compliance issue (s). Once you find the root cause, you can develop a
plan to prevent the same issue from occurring again. This factory did not dig deep enough to do an
effective root cause analysis for this finding. “Management oversight” is an obvious and superficial
assessment of what lead to the non-compliance issue and not the root cause for this finding. Most
findings result from management oversight. The key is to identify the exact part of your current
management system that was insufficient and which resulted in the non-compliance by asking yourself
the “5 Why’s”. Generally the root cause is related to 5 components: 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.

3. Corrective Action does not include all 5 points (Policies & Procedures, Communication,
Training & Skills, Monitoring & Tracking, and Governance & Enforcement)

© 2015 UL LLC Page 11 of 35


Per the picture above, the provided corrective action “We’ve appointed a staff to termly check and
maintain all exit signs” only addresses how the facility will monitor and track this issue. Please refer to
CAPA guidance and note that corrective action is a long-term plan which shall include ALL 5 of the
following components: Policies & Procedures, Communication, Training & Skills, Monitoring &
Tracking, and Governance & Enforcement. If, for example, members of your management team are all
skilled and qualified and no further training is required, then you can mention this under Training &
Skills. Please remember to provide information that addresses all 5 of the required components for
the “Corrective Action” section.

Comment:
-Immediate Action is ACCEPTED;
-Root Cause is INCOMPLETE and must be revised;
-Corrective Action is INCOMPLETE and must be revised.

4. Lack of detail of 5 points in Corrective Action

© 2015 UL LLC Page 12 of 35


In the example above, the corrective actions listed did address all 5 components (1. Policies &
Procedures, 2. Communication, 3. Training & Skills, 4. Monitoring & Tracking, and 5. Governance &
Enforcement), however, each action of the 5 components is oversimplified and does not include
specific detail. Please refer to the guidance covering Corrective action and note that each action
should at least contain basic information like “who, when, how, how often, for whom etc.” See guidance
below in red:

1. Create the first aid policy


a. Who drafted the policy? What information will be added to the policy?
2. Communicate this with all employees
a. How will the policy be communicated? By what means? How often (please include details
about frequency)? Who will be responsible for making sure that these policies are
communicated across your company?
3. Provide training for first aider and employees
a. What kind of training will be provided (please include specific details)? Who will train the
employees? Will all employees be trained on these new policies? How to train/by what
means? How often?
4. Admin. Department inspect the kits regularly
a. Who specifically in the Admin. Dept. will be responsible ? How will this be monitored? What
items should be inspected? How often is regularly (include specific details about frequency:
e.g. monthly, quarterly, and yearly)?)
5. Admin. Department will be responsible for this

© 2015 UL LLC Page 13 of 35


a. Again, who specifically in the Admin. Dept. is the responsible person and what is his/her
title and position? How will details of all of the different steps of this corrective action plan be
managed?

Comment:
-Immediate Action is ACCEPTED;
-Root Cause is INCOMPLETE and must be revised;
-Corrective Action is INCOMPLETE and must be revised.

5. Refusal to submit a CAPA plan

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.

Submitting Results and Adding Evidence

1) Log onto CAPA.

© 2015 UL LLC Page 14 of 35


2) This is the dashboard
screen, and default view
when a factory or
vendor logs onto the
CAPA system. Any time
you need to move
between views, you will
return to the dashboard.

Please note that the


default view for
Vendors/Factories
logging into the system
will be the Item View.

Check the box next to


the finding that you
want to enter then click
Edit.

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.

3) A new screen will pop


up.

Click on the Items tab


just below Summary
Information.

© 2015 UL LLC Page 15 of 35


4) From the Items tab,
select the items that you
would like to view by
checking the box next to
that item number and
then click the Edit
button.

5) In the next pop up


window, click on Item
Information and then
scroll down and enter
comments in the fields
under the Responder
Information sub-
heading.

6) Continue to scroll down.

Click on add evidence


to upload evidence such
as photos, training
certificates, etc.

Include dates with all


uploaded evidence.

NOTE: The maximum number of uploads is 10 files for each item.


Acceptable file formats are: JPG, PDF, WORD, or EXCEL.
Please ensure the file is not larger than 3MB.
File names should be in English characters only.

© 2015 UL LLC Page 16 of 35


7) Click Save. You can click ‘save and close’ and you will be able to come
back later to edit.

NOTE: As a best practice, it is recommended that you click save


throughout the process to save your work.

Evidence files that have been successfully saved to the system


will appear under the File Name heading in the Evidence field
(see screenshot below for reference):

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.

Please note that it is a systems requirement to complete the


following four fields:

• Correction/Immediate Action
• Root Cause
• Corrective Action
• Remediation Completion Date

If you try to submit your CAPA responses and one or more


of the above four fields are not complete, the system will
not allow you to submit and an error message indicating
which of the fields you did not complete will be displayed.

© 2015 UL LLC Page 17 of 35


Approving Facility Responses as a Vendor

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

1) Log onto CAPA.

2) Note: Default view


after you have logged
in is the CAPA Items
view.

Click the findings that


you want to review then
click edit.

3) A new screen will pop


up.

Click on Item
Information.

© 2015 UL LLC Page 18 of 35


4) Scroll down.

If you as the vendor are


uncertain of a response
submitted by the facility
or feel that the
submitted response is
not acceptable, you can
return any response to
the facility for edit or
you as the vendor can
edit on behalf of the
facility (please note that
this step is optional).

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.

© 2015 UL LLC Page 19 of 35


6) If you feel the
responses submitted by
the facility are
acceptable and that
they are ready to
submit to the Approver,
click Submit. Follow
prompts.

7) Once you have


successfully submitted
CAPA responses to the
Client or Managed
CAPA Team, the status
under the CAPA Item
Status field will change
to Pending Approval.
This means that the
Approver needs to
review.

Sending Emails from the CAPA System (From Summary or Item View)

1) Check the box next to


the findings that you
want to send the email
about.

This will cause the


“Send Email Notification”
button to Appear.

© 2015 UL LLC Page 20 of 35


Click the “Send Email
Notification” button.

2) A pop up box will


appear.

Click on “Add
Recipients.”

3) Click the “+” sign to


view users that have
access within the
CAPA system already.

Check the box next to


the user’s email that
you want to send the
email to.

Click “Save & Close.”

You can also manually


type in email
addresses by placing
your cursor in the “to”
line.

© 2015 UL LLC Page 21 of 35


4) Enter subject line and
email body text.

5) Add attachments as
needed.

To add attachments,
click “Select” in lower
right hand corner.

Follow prompts to
open/attach desired
document.

6) Click “Attach Selected”


in lower right-hand
corner.

Once email is ready to


go, click “Send.”

Using Spell Check

© 2015 UL LLC Page 22 of 35


1) If the spell check icon
is next to an editable
field, that means that
spell check is an option
for that field.

2) To use the spell


check, place cursor in
the field that you want
to run the spell check
on.

Click the spell check


Icon.

3) A pop up window will


appear. Follow
prompts.

© 2015 UL LLC Page 23 of 35


4) A note along top of
pop up box will appear
once spell check is
completed.

Click OK on bottom of
pop up box.

REFERENCE INFORMATION

Definitions of CAPA Statuses


The CAPA system uses eight different statuses to identify the progression of each CAPA. The table
below lists the status in order from least to most progress.

**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.**

There are three key roles for the CAPA system:

Responder = Facility
Responder/Reviewer = Vendor (only if applicable)
Approver = Client or UL on behalf of the Client

Status Available Actions Description


Pending Updates may be made by a • First status to begin the workflow when the
Initial Facility Responder and audit has been completed.
Response submitted to a Vendor or a • Indicates that a response is needed from
Vendor can submit responses
the Vendor or Facility in the form of a
to the Client / CAPA
Approver. completed CAPA Plan.

If there is no Vendor in the


supply chain, then the
Responder from the Facility
may submit directly to the
Client Approver.

© 2015 UL LLC Page 24 of 35


Pending Updates may be made by a Pending Vendor Review is the state when the
Vendor Vendor Responder, and CAPA is submitted from the Facility to the
Review submitted to the Client or Vendor. All users may view the CAPA in this
designated Reviewer. state, but the vendor is the only one that may take
action.
If there is no Vendor in the
supply chain this status will
not apply.
Pending Responses have been CAPA Plan has been successfully submitted to
Approval successfully submitted to the Client or Managed CAPA team for review. No
Client or the CAPA Approver. updates can be made with the exception of
comments added by the Approver.

If you accidentally submitted your CAPA


Responses before they were finished (for example
you forgot to attach an evidence file), contact your
Account Representative or contact the Managed
CAPA Team.
Pending The same actions may be Indicates that the Approver requires an
Response taken as when in Pending additional action to be taken on the CAPA Plan
Initial Response. by the responder. Reasons why the approver
requires a change or addition to the CAPA Plan
may include:
• Pending Document Review: The approver
agrees with the approach to remedy the non-
compliance issue, but asks the Responder to
upload documents showing evidence of the
correction.
• Pending CAPA Revision: The CAPA plan
submitted by the Responder was incomplete.
The Responder will be informed of the areas
where the approver would like greater
specificity, and will be asked to re-submit the
CAPA plan again.
Pending Training: The Approver requires the
responder to improve their skills in a particular
area prior to resubmitting the revised CAPA Plan.
Approved No updates or actions may be The CAPA Approver has approved the
made. This is the final state in corrective/preventive action approach, and no
CAPA. further actions are necessary.
Pending No updates or actions may be Scenario 1: The Responder’s approach to address
Onsite made. the non-compliance issues is approved, but some
Verification items need to be verified onsite.
When the verification audit is
completed the status will be Scenario 2: The Responder has reached the
maximum number of CAPA submission attempts
© 2015 UL LLC Page 25 of 35
moved back to Pending Initial and has automatically been switched to Pending
Response. Onsite Verification.

The facility will be contacted to schedule the re-


audit or verification audit at the discretion of the
Client. Timeframe for re-audit is ultimately
determined by the Client and any dates listed in
the next audit timeframe by the CAPA System are
only general suggestions or estimates.
Closed No updates or actions can be An open CAPA was either dropped or deactivated
made. based on Client discretion.

Escalation Definitions

CAPA uses three Escalation Levels: Green, Yellow and Red.


When CAPAs are created they start at an escalation status of Green. They are also set back to green
whenever action is taken against the CAPA. This includes actions that may result in a status change
(e.g. Save does not reset escalation back to green).

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)

Escalation Level Description


Green Set to green when the CAPA status changes and remains
green up to 7 days.
Yellow Set to yellow between 8 and 14 days (i.e. None of the
above actions have been completed after 8-14 days).
Red Set to red starting at 15 days (i.e. None of the above
actions have been completed after 15 days).

When the item Escalation Level changes:


• Last Modified By shows “UL System”.
• Last Modified Date will be updated.
• E-Mail will be sent to vendor and/or facility.

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The change in Escalation Level is displayed in the Detailed History tab.

CAPA Summary Status versus CAPA Item Status

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:

From the CAPA SUMMARY view:


When in CAPA Summary View, you will see one line for all findings associated with a particular audit
regardless of the number of findings associated with that particular audit. The CAPA summary status
will reflect the status of the individual CAPA item that has the least progress. Additionally, the CAPA
summary will reflect the highest escalation level.

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.

From the CAPA Items View:


When in the CAPA Items view you will see one line per each individual finding found during a given
audit. In the example screenshot below we can see that there were two non-compliance findings for
the audit identified by CAPA Summary Number 1058 (one non-compliance finding is for intentional
non-disclosure of subcontractors and the other is a finding related to employees taking work home):

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To switch between the CAPA SUMMARY and CAPA ITEMS view:
When in CAPA Summary view and you want to change to CAPA Item View click on the words “Show
ITEM View” under the CAPA SUMMARIES heading in the top left corner of the page:

You are now under the CAPA Items view.

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:

Viewing Vendor and Factory Supply Chain Contacts

1) NOTE: This can only be


done from the
Summary View.

To view contacts for a


given Vendor or
Factory, start by
selecting a specific
CAPA Summary from
the main CAPA page.
Check the box next to
the CAPA Summary
you want to view and
then click Edit.

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2) A pop up window will
appear. On the left
hand side of the pop-up
window, click on the
Supply Chain &
Contacts tab.

A list outlining the Client


company name, the
Vendor, and the Facility
(if applicable) will
populate.

3) Contact details for the


Vendor and Facility can
be viewed by clicking
on the “+” signs next to
each entity name.

The email addresses


for all CAPA Contacts
will populate under the
company name with
which they are
associated. The email
address also serves as
the contact’s username.

If a contact is not listed


here, they do not have
access to the CAPA
system.

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].

CAPA Email Notifications Overview

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When you receive an automated email from the CAPA system, you need to log into the system
and take action.

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:

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• You will be prompted to name and save the sheet to your computer.
• The system will export the document as an Excel web page by default, but you can also
choose to save the file using the .xls or .xlsx file extensions from the “Save as type” drop down
menu when saving to your personal computer (see screenshot below for reference):

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CAPA Troubleshooting: Log-in Errors

System Requirements for Using CAPA System:


• Only Mozilla Firefox and Internet Explorer supported
• Cookies need to be enabled
• Silverlight needs to be installed
• Operating System has to be Windows-based (Mac not supported)
• Not vetted for use with handheld or tablet devices.
• Time displayed on user’s computer must match the local time when you Google the words
“local time”

Issue: I never received an e-mail giving me my user ID and password.

• 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.

Issue: I forgot my password.

• Go to clientportal.ul.com and enter your email address (e.g. [email protected]) in the


Username field. Click the “Forgot your password?” link on the login page.
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• The system will automatically send you an e-mail with a temporary password.

• 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 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:

Option 1: Upgrade your current browser and/or download Silverlight


If you are using Microsoft Internet Explorer as your internet browser and are unable to access
CAPA, we suggest that you upgrade your browser to the most current version. (Internet Explorer
version 7 or greater is recommended).

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

Option 2: Download an alternative browser


Microsoft Silverlight is also supported by Mozilla Firefox. You can download the most recent
versions of each of these browsers via the following links:

Firefox: http://www.mozilla.org/en-US/firefox/new/

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Option 3: Adjust your browser settings to allow cookies
The UL CAPA system uses an encrypted cookie to store your CAPA security credentials, which
needs to be passed to your browser. If cookies are disabled by your browser settings, your login will
fail.

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

Issue: My account has been disabled

Reset your password after multiple log-in attempts


• You will receive the following error if you try to log in with an incorrect password more than five
times. In this case, you can click on “Forgot your password?” to reset your password and
unlock your account.

[email protected]

Issue: I have my user ID and password, and appropriate internet browser


settings, but cannot log into the system

Option 1: You may need to adjust your computer’s clock


Confirm your computer’s clock matches the local time stated on Google by searching the keyword
“local time” with no quotations.

• 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.

Option 2: Report details of system error to your Client Service Manager

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If you receive one of the following error messages, please forward to your Client Service Manager to
adjust your account settings in our system.

[email protected]

[email protected]

Online CAPA Tool Training Video

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)

[email protected]

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