Nilfisk QMS-6-PRC0145 Process Control Plan Audit User Guide

Nilfisk QMS-6-PRC0145 Process Control Plan Audit

Product Information

• Author: Lugardo Paredes/ Jasson Zhang
• Function: Strategic Sourcing
• Language: English
• Approved by (if required): Laszlo Vilimi
• PCPA: Process Control Plan Audit
• Original released date: 31-03-2017
• Doc. Number: QMS-6-PRC0145
• Rev. Number: 04
• Effective date: 17-Aug-2021
• Pages: 8

Purpose

The purpose of this product is to verify if the supplier is following the defined manufacturing process and quality controls as documented and approved by Nilfisk during the PPAP process. It also serves as a mapping tool for supplier improvement activity.

Scope

This product applies to all direct materials supplied for Nilfisk.

Abbreviations / Acronyms / Terms and Definitions

• CA-PA: Corrective Action Preventive Action
• CC: Critical Characteristics
• PC: Production Company
• PCPA: Process Control Plan Audit
• PFD: Process Flow Diagram
• PFMEA: Process Failure Mode and Effect Analysis
• PN: Part Number
• PPAP: Production Part Approval Process

Reference Documents

The following documents are available in the Document Management System:

• Type of Document: Standard Operation
• Document Number: QMS-1-PRC0040
• Title of Document: Production Part Approval Process
• Type of Document: Work Instruction
• Document Number: QMS-6-070142
• Title of Document: Process Flow Diagram
• Type of Document: Work Instruction
• Document Number: QMS-6-070143
• Title of Document: Process Control Plan
• Type of Document: Work Instruction
• Document Number: QMS-6-070144
• Title of Document: Process Failure Mode and Effect Analysis
• Type of Document: Template
• Document Number: QMS-2-PRC0146
• Title of Document: PCPA Checklist

Product Usage Instructions

• Step 1: Define part for audit
  Start by defining the part that will be the topic of the audit.

• Step 2: Schedule an audit date with the supplier
  Contact the supplier and schedule a date for the audit.

• Step 3: Opening
  Introduce the reason for the audit and provide the questionnaire to the supplier.

• Step 4: Audit
  During production, verify if the documents are being followed.  Conduct a product audit.

• Step 5: Fill in the Checklist and Closing
  Based on the audit findings, fill in the checklist. Then proceed to the closing phase.

• Step 6: Identify CA-PA
  If the audit identifies any gaps, use the Audit Action Plan format to identify corrective and preventive actions (CA-PA).

• Step 7: Verify CA-PA and schedule a follow-up audit
  Verify the effectiveness of the CA-PA and schedule a follow-up audit if necessary.

• Step 8: Finalize the Checklist and upload to SP
  Once all steps are completed, finalize the checklist and upload it to the SharePoint (SP) system.

Specifications

• Author: Lugardo Paredes/ Jason Zhang
• Function: Strategic Sourcing
• Language: English
• Approved by (if required): Laszlo Vilimi
• PCPA: Process Control Plan Audit
• Original released date: 31-03-2017
• Doc. Number: QMS-6-PRC0145
• Rev. Number: 04
• Effective date: 17-Aug-2021
• Pages: 8

Frequently Asked Questions (FAQ)

• Q: What is the purpose of this product?
  A: The purpose of this product is to verify if the supplier is following the defined manufacturing process and quality controls as documented and approved by Nilfisk during the PPAP process. It also serves as a mapping tool for supplier improvement activity.

• Q: What is the scope of this product?
  A: This product applies to all direct materials supplied for  Nilfisk.

• Q: What are the abbreviations/acronyms/terms used in this product?
  A: The abbreviations/acronyms/terms used in this product are  CA-PA (Corrective Action Preventive Action), CC (Critical  Characteristics), PC (Production Company), PCPA (Process Control Plan Audit), PFD (Process Flow Diagram), PFMEA (Process Failure Mode and Effect Analysis), and PN (Part Number).

PURPOSE

To verify if the supplier is following the defined manufacturing process and quality controls as were documented and approved by Nilfisk during the PPAP process. To use as mapping tool for supplier improvement activity.

SCOPE

All direct material that are supplied for Nilfisk.

ABBREVIATIONS / ACRONYMS/ TERMS and DEFINITIONS

SQE

| Supplier Quality Development or Site Supplier Quality Assurance Engineer

COMPANY CONFIDENTIAL
If this is a copy, unless otherwise specified, it is uncontrolled. You must verify the revision before use. Template number QEM-2-040086-01

REFERENCE DOCUMENTS
These documents are available in the Document Management System. To access click on Knowledge/Production&Operation/Global Quality/Quality and Environmental Management System/Site links/Global Document Mgmt Tool

PROCESS DIAGRAM

RESPONSIBILITIES

Supplier Quality Engineer (SQE)

• Identify PN for audit; for selection, consider if the PN was approved (or to be approved) through PPAP; PN was site related issue affected; PN was in scope on the Monthly Supplier Quality Performance meeting; or any PN
• Schedule audit date with supplier – when subject PN is in production
• Conduct PCPA at supplier following audit cycle as: Opening Meeting, Conduct Audit, Closing meeting, Conduct Product Audit as part of PCPA.
• Complete the checklist and share it with the supplier
• Store PCPA checklist on SP
• In case of gaps, work with the supplier on CA-PA
• Monitor CA-PA implementation
• Verify CA-PA effectiveness, may conduct a follow-up audit

SUPPLIER

• Follow PPAP-documented manufacturing process flow, controls, verifications
• Confirm the schedule for PCPA, make sure the requested PN to be in production
• Support SQE (auditor) during PCPA with evidence, including Product Audit
• In case gaps/findings are identified, work out CA-PA with responsible and due dates in the Audit Action Plan Format
• Keep SQE informed about CA-PA implementation progress, and provide evidence as needed
• Support SQE – auditor – in case of follow-up audit required

PROCEDURE

• SQE identifies PN for audit subject, considering:
  • PN approved (or to be approved) through PPAP Level 2-5,
  • PN from Monthly Supplier Quality Performance meeting,
  • Recent Quality issues at Nilfisk PC.
• SQE set up an audit date in agreement with the supplier (PN shall be in production during an audit).
• SQE visits supplier for audit, and follows audit cycle:
  • Opening Meeting (see Appendix 1 for guidelines),
  • Conducting Audit (see Appendix 2 for guidelines),
  • Closing Meeting (see Appendix 3 for guidelines),
• The supplier supports the auditor during an audit and provides the necessary resources.
• SQE takes observations based on objective evidence and notes them
• SQE do scoring at the end of the audit and informs the supplier about the result as part of the Closing meeting.
• SQE and Supplier review and agree on gaps/findings (if any), agree on a timeline to provide CA-PA in the ‘Audit Action Plan’ template as part of the Closing meeting.
• SQE finalizes the audit report and shares it with the supplier and stores on SP.
• Supplier submits CA-PA to SQE.
• SQE monitors CA-PA implementation progress.
• Supplier keeps updated SQE about CA-PA implementation and provide evidence as needed.
• SQE may schedule a follow-up audit to verify CA-PA effectiveness on site.
• Supplier support follow-up audit.

AUDIT REPORT STORE AND NAMING CONVENTION:

• Please load PCPA report to SP→Knowledge→Strategic Sourcing→Teams→Supplier Quality Development→PCPA Folder.
• Naming Convention: PN, supplier name, date (mm-dd-yyyy) of audit, PCPA. Report to be saved as .xls/.pdf.
  Eg: 56116223, Supplier Name, 03-10-17, Approved PCPA.xls

RECORDS

• PCPA Checklist QMS-2-PRC0146
• PCPA Audit Action Plan QMS-2-PRC0146

REVISION LOG

Section| Rev.| Description of Change| Review date| Reviewed by:| Approve date| Approved by:
---|---|---|---|---|---|---
All| 01| Original Release (Initial Version)| 07/04/2017| Laszlo Vilimi| 16/06/2017| Jeff Wagner
All| 02| Added product audit to the SOP, replaced OIL with Audit Action Plan| 30/01/2018| Laszlo Vilimi| 09/02/2018| Jeff Wagner
All| 03| Added monthly Site-GSQM TOP worst suppliers meeting to the SOP and remove TOP30 list.

(New document ID. Original ID: QMS-6- 080145)

| 31/05/2019| Zoltan Juhasz| 14/06/2019| Laszlo Vilimi
All| 04| Reviewed, changed GSQE to SQE| 05-Aug-2021| Jasson Zhang, Lugardo Paredes, Zoltan

Juhasz

| 23-Aug-2021| Laszlo Vilimi

OPENING MEETING

• Introduce yourself and Nilfisk audit team members, (if any);
• Record names, positions, contact info for all attendees of Supplier auditee team;
• Confirm purpose, scope and reason of audit;
• Discuss role of each team member, (if any);
• Indicate criteria of the audit;
• Present and confirm the audit plan;
• Discuss the responsibilities of the supplier’s management representative;
• Emphasize the objective of the audit and a positive approach;
• Discuss how the audit will be conducted;
• Confirm the supplier’s working hours;
• Confirm arrangements for supplier’s facilities, documentation availability;
• Confirm the date and time of the closing meeting;
• Clarify If you are allowed to take pictures/get a copy of evidence;
• Thank the supplier in advance for its cooperation.

CONDUCTING AUDIT

• Obtain the names of guides and contacts for areas being audited;
• Use the PFD/PCP/PFMEA (as applicable) to verify them. Conduct the audit following the material flow on the following areas:
  • Incoming Inspection/Receiving Area, Raw Materials Warehouse,
  • Complete Manufacturing Processes – up to Packaging, Labelling & Shipping,
• Sensitive Materials Storage Area, Chemical Storage, MRB area,
• Laboratories: Calibration, Failure Analysis, Chemical, Reliability etc.
• Choose part randomly for Product Audit. Identify features to be measured on the part.
• Note down all information and observations for summary afterward;
• After the audit, make a preliminary scoring overview to inform the Supplier about the result (allocate time for yourself with audit team to make the pre-evaluation.

Suggestions:

• Print out the Checklist for the audit team members – everybody can follow the questions and you can take note on it;
• Record Objective Evidence:
  • Document Numbers & Revisions
  • Workgroup/Stations audited,
  • Samples Taken,
  • What Was Observed (good & bad),
  • What Was Seen on Inspection and Test Records;
• Talk to Operators;
• You may conduct a Status Review of the audit after sessions are completed;
• Documentations, Records, & Procedures in line with PFD/PFMEA/PCP;
• Suggest focusing on CCs and important characteristics for product audit measurement.

CLOSING MEETING AGENDA

• Express appreciation for the organization’s time and resources;
• Summarize Findings / Clarification (highlight the good!)
  • Present an explanation of the findings (non-conformities) in the organization’s process;
  • Provide the audit team with the opportunity to demonstrate the validity of the non-conformities;
  • Provide the organization with the opportunity for explanation or response to the non-conformities;
  • Discuss opportunities for improvement detected during the audit;
• Present Audit Team Preliminary Result (Scores for disposition);
• CA-PA Plan submission agreement;
  • Focus the organization’s attention on the significance of the findings (non-conformities) and the need for corrective action;
  • Discuss the importance of corrective action(s) and establish a deadline for the submission of the corrective action plan and/or action(s) emphasizing that the organization is responsible for a corrective action plan and actions(s);
• Confirm who will receive a copy of the audit report and when;
• Follow-Up Actions.

References

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