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Standard Operation Process For New Product Introduction

The document outlines the Standard Operating Process (SOP) for New Product Introduction (NPI), emphasizing collaboration among stakeholders such as Senior Management, Product Management, QA, Compliance, 3rd Party Inspection, and Suppliers. It details responsibilities, communication channels, decision-making guidelines, documentation practices, issue resolution, and continuous improvement measures. The SOP aims to ensure successful NPI through structured processes and regular reviews.

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12 views2 pages

Standard Operation Process For New Product Introduction

The document outlines the Standard Operating Process (SOP) for New Product Introduction (NPI), emphasizing collaboration among stakeholders such as Senior Management, Product Management, QA, Compliance, 3rd Party Inspection, and Suppliers. It details responsibilities, communication channels, decision-making guidelines, documentation practices, issue resolution, and continuous improvement measures. The SOP aims to ensure successful NPI through structured processes and regular reviews.

Uploaded by

imagevision2046
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
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Standard Operation Process for New Product Introduction

Objective
To establish collaborative and effective processes among all relevant stakeholders to ensure NPI success.

Stakeholders and Responsibilities


Senior Management:
Provide overall direction and support for the QA team.
Review and approve all testing plans and reports.
Address any high-level issues or concerns.
Product Management:
Provide clear and concise product requirements and specifications.
Collaborate with the QA team to define testing criteria and acceptance criteria.
Participate in design reviews and risk assessments.
Provide feedback on testing results and suggest necessary improvements.
QA:
Plan and execute all product testing activities.
Communicate testing progress and results to all stakeholders.
Address any concerns or issues raised by stakeholders.
Maintain accurate and up-to-date documentation of all testing activities.
Collaborate with stakeholders to resolve any issues or discrepancies.

Ensure compliance with all relevant regulations and standards.


Compliance:
Provide guidance on all relevant regulations and standards.
Review and approve all testing procedures and protocols.
Monitor compliance with all regulatory requirements.
Assist in addressing any regulatory issues that may arise.
3rd Party Inspection:
Managed by QA manager.
Conduct independent inspections of products and processes.
Provide feedback on inspection findings.
Assist in identifying areas for improvement.
Supplier:
Managed by product manager.
Provide product and technical support.

Communication Channels
Meetings:
Monthly meeting:
all stakeholders
review project status
Bi-Weekly meeting:
PM, QA, Compliance
review project activities
Meetings: regular / adhoc

QA and 3rd Party Inspection Agency


Review project activities
Email:
All stakeholder report to senior management
QA Communication with 3rd party inspection agency
Ad hoc email to report issues
Project management activities tools:
Confluence:
create document
develop work break down
create user story
save lessen learned
Jira:
create actionable item
assign person-in-charge
log result and issue

Decision Making Guideline


All major decisions regarding testing activities, including test plans, protocols, and acceptance criteria, will be
made through consensus among the QA team, Product Manager, and Regulatory Compliance Officer.
The 3rd Party Inspection Agency will provide independent input on all major decisions.
Senior Management will provide final approval on all strategic decisions.

Documentation
All activities, including test plans, protocols, results, and reports, will be documented thoroughly and
maintained in a central repository.
All communication with stakeholders will be documented and archived.

Issue Resolution
Any issues or discrepancies identified during any step will be logged and communicated to relevant
stakeholders.
A root cause analysis will be conducted to identify the underlying cause of the issue.
A corrective action plan will be developed, implemented and approved.

Continuous Improvement
This SOP will be reviewed and updated quarterly to ensure its effectiveness and relevance.
Feedback from all stakeholders will be considered during the review process.

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