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The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region OASIS Next Gen Project NCR Management March 31, 2017 V3

Transcript of OASIS Next Gen Project NCR Management - · PDF fileOASIS Next Gen Project NCR ... the OASIS...

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The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region

OASIS Next Gen Project

NCR Management

March 31, 2017

V3

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Instructions

• This guidance material was created to provide userinstructions for the creation and management of theon-line Non Conformance Report (NCR) report withinthe OASIS database, including:– High Level Path - process flow

– AQMS Auditor Steps• NCR generation

• Response review

• Acceptance

– Supplier Organization Steps• Acknowledgement

• Corrective action input

– NCR Notification• Step by Step instructions

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OASIS Next Gen NCR Management(Form 4)

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OASIS Next Gen NCR Management(High-Level Path)

NCR ManagementNCR Management

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Audit Set-up

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Number

Enter details, define

Due Date and Sign-off

(NCR Opened)

STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 STEP 6

Access Audit

Number

Aknowledge and

Sign-off

receipt of NCR

Review of

Organization

Planned Actions

Define & Submit

Organization

Planned Actions

and Sign-off

Accepted &

Sign-off

Verification and

NCR Closure

Verification and

NCR Closure

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AQMS Auditor Steps

After logging in to

OASIS, click

“Manage Audits”

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Select Status:

“New WIP” or “Any”Then click “Search”

AQMS Auditor Steps

Work in Process (WIP)

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Click on applicable

audit reference number

AQMS Auditor Steps

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In conjunction with other

audit package entries,

click Form 4 arrow

Then click “Add New”

AQMS Auditor Steps

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Click “Import” to select

and upload supplier

site information

Enter Section 1

Nonconformity Details

Add discussion data

and notes as applicable

AQMS Auditor Steps

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Click “Add New” to add

Discussion and Notes

AQMS Auditor Steps

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Click to add attachment

Enter Subject and

message details

AQMS Auditor Steps

Click “Add Row” to add

other attachment(s)

Click “Post” to publish

Discussion

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Click to add attachment

Enter Subject and

message details

AQMS Auditor Steps

Click “+Add Row” to add

other attachment(s)

Click “Post” to publish

Discussion

Click “x” to remove

attachment(s)

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AQMS Auditor Steps

Posted discussion and Note

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Then click to sign for

Section 1 entries

AQMS Auditor Steps

Click to save changes

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Supplier Organization Steps

Click on applicable

audit reference number

Select Status:

“New WIP” or “Any”Then click “Search”

After logging in to

OASIS, click

“Manage Audits”

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Supplier Organization Steps

Click on applicable

audit reference number

Select Status:

“New WIP” or “Any”Then click “Search”

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Supplier Organization Steps

Click on applicable

audit reference number

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Supplier Organization Steps

Click Form 4 arrowThen click applicable

NCR number

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Supplier Organization Steps

Click to view and enter

discussion data and notes

as applicable

View nonconformity

details

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Supplier Organization Steps

Click to access designated

organizational representative

name(s)

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Select organizational

representative name

from drop-down list

Enter NCR receipt date

Click to save entry

acknowledging receipt

of NCR

Supplier Organization Steps

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Supplier Organization Steps

Enter Section 2

planned action details

and dates

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Supplier Organization Steps

Click to add attachments

as applicable

Click to save data entries

After saving data, click to

access designated

organizational representative

name(s)

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Supplier Organization Steps

Select organizational

representative name

from drop-down list

Enter Section 2

completion date

Click to save entry

acknowledging completion

of Section 2

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AQMS Auditor Steps

After logging in to

OASIS, click

“Manage Audits”

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Select Status:

“New WIP” or “Any”Then click “Search”

AQMS Auditor Steps

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Click on applicable

audit reference number

AQMS Auditor Steps

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Click Form 4 arrowThen click applicable

NCR number

AQMS Auditor Steps

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Review Section 2 informationClick to add attachment

as applicable

Click applicable button to either

sign (accept) or reject

Section 2 information

AQMS Auditor Steps

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Supplier Organization Steps

Click on applicable

audit reference number

Select Status:

“New WIP” or “Any”Then click “Search”

After logging in to

OASIS, click

“Manage Audits”

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Supplier Organization Steps

Click on applicable

audit reference number

Select Status:

“New WIP” or “Any”Then click “Search”

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Supplier Organization Steps

Click on applicable

audit reference number

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Supplier Organization Steps

Click Form 4 arrowThen click applicable

NCR number

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Supplier Organization Steps(With Rejected Stage 2 Response)

Review rejection reason

Click to access designated

organizational representative

name(s)

Add attachment

as applicable

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Supplier Organization Steps(With Rejected Stage 2 Response)

Click to edit planned actions

Click to save changes

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AQMS Auditor Steps

After logging in to

OASIS, click

“Manage Audits”

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Select Status:

“New WIP” or “Any”Then click “Search”

AQMS Auditor Steps

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Click on applicable

audit reference number

AQMS Auditor Steps

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Click Form 4 arrowThen click applicable

NCR number

AQMS Auditor Steps

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Review Section 2 informationClick to add attachment

as applicable

Click applicable button to either

sign (accept) or reject

Section 2 information

AQMS Auditor Steps

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Enter verification details

AQMS Auditor Steps

Click to access

auditor name(s)

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Enter NCR closure date

AQMS Auditor Steps

Check applicable

auditor name(s)

Click to add name(s)

and date to Section 3

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AQMS Auditor Steps

Audit team leader

click to access name

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Enter NCR closure date

AQMS Lead Auditor Steps

Check lead auditor name

Click to add name

and date to Section 3

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AQMS Lead Auditor Steps

Lead auditor Section 3

acceptance updates

NCR status to “Closed”

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The management of NCRs raised during the auditprocess is associated with a series of emailnotifications that are automatically generated bythe OASIS database system.

Email notifications are sent to user roles/events foreach of the steps identified in the NCR Form 4 (seenext slide) when an NCR is generated.

Each of the events that trigger the emailnotification, will also log the applicable informationor each event.

NCR events are tracked in a way they can later beused for Supplier Advisories.

NCR's Notifications

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NCR's Notifications

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CB

Audit

Entry

Admin

Supplier

RepAuditor

Lead

Auditor

Auditor completes Form 4

(NCR) and confirms it is done

by signing off (Auditor).

16 No Y Y Y

If Auditor or CB modifies

Section 1 after it is submitted

to the supplier.

No Y Y Y

2

Supplier Rep Acknowledge

receipt of NCR report

(Organisation Representative)

17 No Y Y Y

3

Supplier Rep Submits

"Organizations Planned

Actions" for review by auditor

by filling in applicable fields

and signing off (Organisation

Representative)

28 No Y Y Y

Notification Goes To

NotesSteps EventForm

Box #

1

NCR's Notifications

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CB

Audit

Entry

Admin

Supplier

RepAuditor

Lead

Auditor

Auditor accepts the actions

documented in Form 4 -

SECTION 2 – ORGANISATION’S

PLANNED ACTIONS and signs

off on acceptance (Auditor

Acceptance)

29 No Y Y Y

Auditor rejects the actions

documented in Form 4 -

SECTION 2 – ORGANISATION’S

PLANNED ACTIONS

Clears the previous step3 No Y Y Y

Containment Action Planned

Completion Date exceeded

OASIS will send a daily

containment action reminder if

1 - Form 4 box #14

containment required is

identified as "yes"

2 - Form 4 box #21 planned

completion date is exceeded

AND the actual completion

date Form 4 box #22 is not

filled in.

Y Y Y Y

Corrective Action Planned

Completion Date exceeded

OASIS will send a daily

corrective action reminder if

1 - Form 4 "#26 planned

completion date" is exceeded

AND the actual completion

date Form 4 box #27 is not

filled in.

Y Y Y Y

Ready for Auditor verification

Ready means the Actual

Completion Date Form 4 box

#27 for the Corrective Action

has been entered.

No Y Y Y

NotesSteps EventForm

Box #

Notification Goes To

4

NCR's Notifications

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CB

Audit

Entry

Admin

Supplier

RepAuditor

Lead

Auditor

If Originating auditor

approves and signs off

(Auditor Acceptance)

29 No Y Y Y

If Originating auditor rejects Need to enter "reason for

rejection"No Y Y Y

If Auditor or CB modifies

Section 2 after it is submitted

to the supplier

No Y Y Y

Lead auditor approves and

signs off the NCR is complete

(Audit Team Leader)

32 No Y Y Y

Lead auditor rejects NCR

completeness 32

Ned to enter "reason for

rejection"No Y Y Y

NotesSteps EventForm

Box #

Notification Goes To

5

6

NCR's Notifications

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Discussion

Originator

CB

Audit

Entry

Admin

Supplier

RepAuditor

Lead

Auditor

Discussions and responses to

discussionsY No Y Y Y

Attachments Adding an attachment to an

NCRNo No Y Y Y

Auditor Deletes an NCR before

it is assigned to a supplier for

review/action

The status is WIP.. No No No No No

Auditor changes the status to

something such that it is no

longer an NCR (cancelled,

changed to an observation,

changed to improvement)

Requires a reason for change Y No Y Y Y

Notes

Notification Goes To

Steps EventForm

Box #

Misc

NCR's Notifications

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Questions