MPR-DOC-WI-009088 Revision6.Xpage 1 of 26

MPR-DOC-WI-009088 Revision6.XPage 1 of 26

Review and Approve FACTORYworksTMChanges

/ Document Number:MPR-DOC-WI-009088 / Revision6.X
Work Instruction / Title:Review and ApproveFACTORYworksTMChanges
Quality System Element / Document Control
Scope / MPROC Sites FACTORYworks changes.
Purpose / Establish a procedure toperform FACTORYworks changes.
To provide adequate review and approval of all FACTORYworks changes to ensure that all applicable requirements are met and implementations are complete and correct.
Reference Documents / Global FACTORYworks Reporting Portal (Link)
MDT1787008 (MES00473) FACTORYworks Configuration Guide
ITD.0077MPROC-IT Change Management ProcessMPR-PP-DOC-009038 Device History Records (MPROC)
MPR-DOC-FM-009144FACTORYworks Change Order Form
MPR-DOC-FM-009143 FACTORYworks Change Attachments Form
MPR-DOC-WI-009142- FW Configuration Management DOC
QSC.0037 Authorized Signature (MPROC Juncos Site)
SFRM.1267List of Authorized Personnel As Per SQSC.0027
V090000-000Firmas Autorizadas De Los Documentos de Manufactura e Instrucciones Generales
SFRM.0898 - Master List – MPSS Product Specifications for Product Labels
SFRM.0990 - MPSS Documents Current Revision Notification Form
Groups or Functions Impacted / Engineering | Quality | IT | Finance | Configuration Assurance
Records and Maintenance
Record Description / Start of Retention Period / Record Code1
Change order Form / N/A / INT2010
1See Corporate Retention Schedule for record code definitions and length of time to retain the record.

1. Change Information

Reason for Change / Correct Typing / Document ErrorInitial ReleaseSelectImplement Deviation / VarianceProcess ImprovementResponse to CAPA No.Response to External Audit FindingResponse to known / potential performance riskField IssueImplement Change ControlAdministrative ChangeInactivate
Background / Why is Required / Process improvement
Description of Change / 1) Clarify SME roles and responsibilities.
2) Specify Confirmation Lot Requirements for Products, Steps and Serial Number.
3) Add the General Guidelines for Serial Number changes.
4) Add BOM verification against PDM instructions.
5) Remove Qualification Required column from Table 1
6) Remove the instructions for Inactive/Release Build Profiles.
Justification for Change / To change MPR-DOC-WI-009088 in order to improve confirmation lot at production environment and being able to change Serial Numbers.
Process Section Affected / Section B, Section E (1.12), Section E (2.1.10)

1. Definitions and Acronyms

Term / Definition / Description
Administrative Change / A change which is not Mfg. Process Controlled and does not affect quality control or traceability
Areas / A collection of equipment and inventory areas
Attributes / Defines characteristics or behavior of products, equipment, steps, and process plan
BOM / Bill of materials of an assembly
Build Profile / Logical linkage between the step of a process plan and the location of an assembly. Defines what material is consumed at each step.
Business Rules / Communication mechanism; allow the execution of attributes and data collection plan in a step
Configuration Change / A change in to FACTORYworks that affects quality control or traceability (Changes in FW are performed using IDE and VICE system)
EDC / Engineering Data Collection
Emergency Change / An emergency change is one where the process is required by production immediately e.g. line stopped, quality issue, yield loss.
Equipment / The machinery or device where work is being performed
Equipment Controller / An outside program that functions with specified equipment
FACTORYworks Intelligent Client / The program that resides on the manufacturing floor computers
SME / FW Subject Matter Expert, support change management by approving FW Requested changes and assisting in the assessmentto prevent line disruptions and/or FW errors when the changes are transferred to production line.
FW / FACTORYworks. This is the Manufacturing Execution System (MES).
IDE / Integrated Development Environment, used to configure the FACTORYworks environment
Location / Name of a part number in the BOM. This linkage BOM with Build Profile.
MES / Manufacturing Execution System
Mfg Process Driven Change / A change to FACTORYworks configuration that is driven by a change in the manufacturing process.
Monitor / A ‘monitor’ is a sample that runs through a manufacturing process step to check for correct functioning of the process. It is tracked as a lot with LotType = “Monitor” in FACTORYworks. The ‘monitor’ is a sample that will be sent (using other business rules) to a laboratory or representative to be tested, to gather data on the performance of the process and/or the equipment.
Normal Change / A normal change is one where the finished copy is required by production on a date that is not critical. These changes will be released to production as indicated by requestor.
PDM / Product Data Management, used to control the design components of an assembly. Examples of these are Agile, SAP, Enovia.
Process Plan / Sequence of steps to build a product.
Product / Authorized structure to be built (Assembly or raw material).
Resource (Equipment Type) / Used to link steps with site model area, this enables the step or steps function in the specified area.
Rush Change / A rush change is one where changes will be released to production within 3 working days.
Confirmationlot / Lot used to test the FW configuration
Site Model / A collection of areas and equipments
Step / An individual work sequence. Contains references to manufacturing work instructions, equipment, parts, etc.
SterilizationLot / By convention, all sites use this attribute to hold the sterilization batch number. This name is not hard-coded in the business rules. It is entered via the MonitorCopyAttr attribute on the sterilization equipment.
VICE / Verid Integrated Configuration Environment, used to configure the BOM and build profile for assemblies
WIP / Work In Process on the Mfg. Floor
PRA / MRA / Product Release Authorization / Material Release Authorization
FAI / First Article Inspection

1. Process Flowchart

Flowchart I with General Guidelines of FW Changes for: “Steps”

Flowchart II with General Guidelines of FW Changes for: “Process Plan”

Flowchart III with General Guidelines of FW Changes for: “Build Profile”

Flowchart IV with General Guidelines of FW Changes for: “BOM of New Model/Assembly/ Pin”

1. Responsibility

Role / Responsibility
Configuration Assurance Representative / Perform configuration changes submitted according to MPR-DOC-FM-009144 and procedure MPR-DOC-WI-009142
Engineering Representative or Designee / Comply with the requirements described in this process.
Submit the necessary configurations in FW system in order to provide the correct routing and management of products through the Manufacturing Processes.
Ensure that production is not affected by a configuration change prior of the released of it.
Coordinated the released of the changes with production.
Update if required work in process affected by the change.
QA Engineering Representative or Designee / Verify the changes on unreleased state. If the requestor is a Quality Engineer a different Engineering Representative or designee must review the changes.
FCAB Team / Review and Authorize the execution of the changes submitted. The team is composed by identified FW Subject Matter Experts.
Finance Representative / Read and acknowledge changes that could have a financial impact.
Manufacturing Representative / Read and acknowledge changes that could have a manufacturing floor impact.

1. Instructions

1.0FACTORYworks changes

1.1FACTORYworks changes must be created and reviewed according to this procedure.

1.2Request a FACTORYworks Change Order Control Number to Documentation department before submitting FACTORYworks Change Order MPR-DOC-FM-009144, complete all applicable sections and attach related forms and reports documentation as required. All related attachments (forms and reports), must have the FACTORYworks Change Control Number and Page identification.

NOTE:

-When using FACTORYworks Reporting Portal, the Webpage report must be submitted, even if you submit the excel report.

-PRA/MRA/FirstArticle attribute should be added to product after FAI approval with MPR-DOC-FM-009144,

-For Sterilization area a “Monitor” product must be created.

-For Equipment controllers is not require to generate MPR-DOC-FM-009144 unless a FW configuration is affected.

-Make sure that the modificationsdo not contradict any POD’sinstructions.

-All changes submitted required revision update, except site model area or equipment changes.

1.3It is required that all applicable sections and attachments be included and sections that apply be completed prior to submit FACTORYworks change order MPR-DOC-FRM-009144 to FCAB team. The Engineering Representative must sign section 4 ”Process Plan” and Section 6 “BOM” of the FACTORYworks Change Order Form as applicable. The Engineering Representative must confirm that the submitted BOM configuration matches the information from the appropriate PDM specification.

1.4Submit and discuss FW Change Order with FCAB for approval.

1.5Submit FW Change Order MPR-DOC-FM-009144 with attachments to Configuration representative.

1.6Configuration representative will complete configuration and sign off the Change By on MPR-DOC-FM-009144

1.7Quality Engineering Representative or Designee (second verifier) must review the changes on unreleased state using FW reporting tools or related forms. Signature of Verify By/Date is required in all the attachments when verified, and sign the FACTORYworks change order MPR-DOC-FM-009144. For changes or creation of reason codes, EDC measurement specs and categories this verification will occur in a released state.

1.8If the requestor is a Quality Engineering representative or designee a different Quality Engineer representative or designee must review the changes.

1.9Once configuration is completed and verified, Requestor and/or Second Verifier must notify Configuration representative when to release if date is different from the Planned Date in the MPR-DOC-FM-009144

1.10Configuration Assurer must complete the Change Released By section on MPR-DOC-FM-009144.

1.11Changes that requireConfirmation Lot: (Refer to Table 1 for details)

Table 1 Detail FW Changes
Configuration Category / Testing
Confirmation Lot / Roll Out Required
Required / Not Required
Product / FP Product LabelAttributes (Provide Printed Label confirmation)
Equipment / Monitor Attributes / X
Areas / X
Reason Codes
EDC
BOM
Build Profile / X / Property Name or
Revision Control
Process Plan / X (Including Monitor Process Plan creation) / Description or
Revision Control
Steps / Rules ChangesX / Administrative Changes (Description, Attributes that do not affect product label, Rules, EDC with no Validation limits, Wait for Dispatch, Equipment/Resource/Area)
Serial Number

1.11.1If a confirmationlot is required, the requestor must coordinate with mfg. operations to run the confirmation and to establish the release date.

1.11.2Confirmationactivities are required for upgrades to process plan revision to incorporate the changes requested.

1.11.2.1If necessary create a “Dummy” Lot by using Start New Lot Client Rule.

1.11.2.2Induct the required raw materials to be consumed by using Induct Lot Client Rule.

NOTE: Do NOT use Induct Lot from JDE Client Rule to induct raw material to be consumed.

NOTE: Lots used for confirmation run must be representative of the product being tested. All manufacturing steps and material consumptions must be performed.

1.11.3Execute the confirmation run.

1.11.3.1The following are items to be inspected in the lot traceability:

1.11.3.2Within FACTORYworks, pull up the Lot Number of the parts you are inspecting.

1.11.3.3Using PDM ensures the Component Product Number matches those listed in the “Consumed Parts” of the lot traceability.

1.11.3.4Use PDM when apply to ensure correctness of change performed during simulation.

1.11.3.5Ensure the part number and quantity is correct per the label on the product under inspection.

NOTE: For Non-quantifiable material (e.g. rubber for Silicone Molding or Silicone adhesive), the quantity column in the traceability record will state “1”.

1.11.3.6If applicable, verify the Manufacturing Date and Use Before Date in the product traceability matches with the product label.

1.11.4If the confirmation lot results met the requirements, document it as “Passed” and write lot number used for in the MPR-DOC-FM-009143 as evidence that change was successfully completed. The requestor must notify the configuration assurance representative.

1.11.5If the confirmationlot results are not satisfactory, document it as “Fail” in its corresponding table of MPR-DOC-FM-009143 and include the failure reason along with corrective action that must include the new FACTORYworks Change Control Number to correct the failure.

1.11.6Unit(s) used for the confirmation run must be “terminate” in the FW system.

1.11.7Configuration Assurer must complete the Confirmation Lot Completed section on MPR-DOC-FM-009144.

NOTE:First Article Inspection (FAI) and Operational Qualification activities supersede the confirmation run. Therefore section # 13 of MPR-DOC-FM-009144 not required.

2.0Sections

2.1General Guidelines of FW Changes for: “Steps”

Step in the manufacturing process is a collection of work instructions (business rules) performed on a given resource. Creating a step consists in giving a unique name. A change to be conducted in the current step attributes (i.e. doc name, values) could impact different process plans.

NOTE: For Sterilization area a “Monitor” release step must be created and included in a “Monitor” Process Plan.

2.1.1“Equipment Type”, “Equipment Group” and “Area” will be used as step resource types.

2.1.1.1In general, each production step will have at least one business rule. The order of the business rules must be provided on the MPROC Form #MPR-DOC-FRM-009143.

The most common business rules are:

StartJDEOperation – this rule is required if the step attributes is set. It is used for pay points.

TrackInOut - this rule is required for running product lots through an assembly plan step. It process the 'normal' case (track in, consume material, and track out) with a single button click to confirm completion.

EndProcessing – This rule is attached to the end of every process plan in order to do clean up work and to verify all parts (BOM) were consumed as required.

CalculateUBD – it is an in-line rule that allows for the calculation of the use before date of the lot.

CollectData – This rule collects EDC data from the end user.

ABOMVerification - This rule performs a validation of the ABOM against the manufacturing BOM. It is used in rework configurations and it is included in the last step of the process plan.

ViewPODs - This rule enables the user to view PODs for a particular step.

AutoRemoveAndReplace - This rule removes and replaces specified components in an assembly. It can scrap, reclaim, and/or consume components at any level of the As-Built Configuration. Its actions are directed by step attributes and the BOM. This rule is used on rework steps.

Repair - This rule enables an engineer to specify parts in an assembly to be repaired and an operator to perform repairs. This rule is used on rework steps.

2.1.1.2Currently these are the most commonattributes defined for a step:

DocName - The POD number to be displayed for the step. Values are None, blank or a POD number. If this attribute is missing or blank, the product attribute DocName will be used.

StartJDEOperation - it is use to set the JDEOperation lot attribute. Examples are: “010.00”, “020.00”, and “030.00”.

EdcPlanName - Contains the name of the EDC plan name for this step.

InventoryLocation - Define the inventory area that a lot will be moved when finishes processing.

SetManufactureDate - “FALSE” Don’t affect lot. ManufacturingDate or lot UseBeforeDate.

“NOW” Set lot ManufacturingDate to Now and compute lot UseBeforeDate (using product ShelfLife). This is the most common used on a step.

“PROMPT” Ask the user for lot ManufacturingDate and compute lot UseBeforeDate.

DisableAutoMaterialSelection - If this step attribute is present and set to “TRUE”, no material lots will be selected by default in the Material Consumption grid. The user will be forced to directly indicate which lots will be consumed.

JDECompletionLocation - Place this only on a step where EndProcessing will convert a lot to the next higher BOM level and will change the work order number in the process.

RepairCommandFP1 - This is use for rework steps between Final pack and 500 level. It is used to configure the components to be removed at Final Pack level.

SubassyBOMVerificationEnable - This attribute is use on rework steps at different levels. It is used to verify that all components of the BOM were consumed. The accepted values for this attribute are YES or NO.

RepairReassignEnable - This attribute is set to reassign the lot to a different process plan. The accepted values for this attribute are YES or NO.

RepairNextRule - This attribute is used to define the rule that system will execute after repair execution (e.g. TrackInOut).

RepairCommand1 - This is use for rework steps between 500 and 400 level. It is used to configure the components to be repaired (e.g. Comp1;Comp2;…).

FPComponentToReassign -This attribute is used to define the component at Final Pack to be reassigned (e.g. Lead).

LabelName - The name of the label that will be printed at this step.

Signature-Required - If “FALSE”, no electronic signature is required at this step (for normal track-out). Any other value or missing: a signature is required.

2.1.1.3Step names must match the physical production area except when they are rework steps. Rework step names will start with “Rwk”.

2.1.2General Guidelines of FW Changes for: “Process Plan”

2.1.2.1.1Process plans define the sequence of steps of manufactured products from start to finish. Creating the process plan consists of identifying logical groupings of steps (sub-processes) and defining their relationship (flow). Creating a process plan consists of giving it a unique name and description (optional).

NOTE: For Sterilization area a “Monitor” process plan must be created and assigned to “Monitor” product.

2.1.2.1.2Engineering Representative or designee must verify that changes performed to a process plan matches with it corresponding base document.

2.1.3General Guidelines of FW Changes for: “Build Profile”

2.1.3.1.1A Build Profile is a logical linkage between the steps of a process plan and the locations of an assembly defined on the BOM.

2.1.3.1.2A change on an existing build profile required an upgrade of the revision.

2.1.3.1.3The Optional attribute is a feature to allow you to indicate that a given BOM location can be consumed at any one of multiple steps. It is required to be defined as True or False on the MPR-DOC-FM-009144:

• True - The indicated BOM-location may or may not be consumed at the indicated step.
• False - The indicated BOM-location must be consumed at or before the indicated step (before the lot can be tracked out).

2.1.4General Guidelines of FW Changes for: “BOM”

2.1.4.1A BOM is a list of the materials to be used while manufacturing a product, the list should include the material and the amount required for each material. For new configuration the product must be in FW prior to creating the BOM.

2.1.4.2Each feeder and assembly has a unique Manufacturing Bill-of-Material (MBOM).