Podcast
Questions and Answers
What is the first piece of information entered into a new log entry for a customer request?
What is the first piece of information entered into a new log entry for a customer request?
Where should a folder be created to capture customer requests, as specified in the document?
Where should a folder be created to capture customer requests, as specified in the document?
Which of the following is an example of the correct folder naming convention for customer compliance requests?
Which of the following is an example of the correct folder naming convention for customer compliance requests?
After creating a folder for the customer request, what is the next step to be performed?
After creating a folder for the customer request, what is the next step to be performed?
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Who is responsible for sending the acknowledgement email to the customer?
Who is responsible for sending the acknowledgement email to the customer?
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What information is specifically included in the folder created to capture the request?
What information is specifically included in the folder created to capture the request?
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Which of the following actions is NOT completed by the Quality Specialist, according to the document?
Which of the following actions is NOT completed by the Quality Specialist, according to the document?
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What does PPC Requestor indicate in the customer request log entry?
What does PPC Requestor indicate in the customer request log entry?
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Which department is responsible for initially receiving and forwarding customer documentation requests to the quality department?
Which department is responsible for initially receiving and forwarding customer documentation requests to the quality department?
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Who is responsible for the implementation and review of the 'Processing Customer Requests' work instruction?
Who is responsible for the implementation and review of the 'Processing Customer Requests' work instruction?
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If a customer requests a Safety Data Sheet (SDS), to whom does the Technical Sales Department send the request?
If a customer requests a Safety Data Sheet (SDS), to whom does the Technical Sales Department send the request?
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Which individual is responsible for logging the closure of a customer documentation request?
Which individual is responsible for logging the closure of a customer documentation request?
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Which of these is NOT a type of customer documentation request outlined within the scope of this document?
Which of these is NOT a type of customer documentation request outlined within the scope of this document?
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What is one responsibility of the Quality Specialist related to supplier compliance?
What is one responsibility of the Quality Specialist related to supplier compliance?
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Which of the following is a customer compliance request specifically mentioned in the provided document?
Which of the following is a customer compliance request specifically mentioned in the provided document?
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Who is responsible for reviewing and approving sales agreements, according to the document?
Who is responsible for reviewing and approving sales agreements, according to the document?
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What is the correct location to save the PPC statement?
What is the correct location to save the PPC statement?
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Which document should be sent back to the customer?
Which document should be sent back to the customer?
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After moving the file to the completed folder, what is the next step?
After moving the file to the completed folder, what is the next step?
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What must be included when logging the completed request?
What must be included when logging the completed request?
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How should proprietary attachments from suppliers be handled?
How should proprietary attachments from suppliers be handled?
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Where will the compliance information and PPC statement be moved post-completion?
Where will the compliance information and PPC statement be moved post-completion?
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Which document outlines the procedure for controlling records?
Which document outlines the procedure for controlling records?
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What change is noted in the revision history?
What change is noted in the revision history?
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What should be done with a previous revision to the agreement in the eQMS?
What should be done with a previous revision to the agreement in the eQMS?
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Where should the Customer Agreement information be logged?
Where should the Customer Agreement information be logged?
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What is the minimum record retention requirement for agreements?
What is the minimum record retention requirement for agreements?
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What action is required if customer requirements go beyond the 7 years retention?
What action is required if customer requirements go beyond the 7 years retention?
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Which document provides guidance on the Change Control Order/Document Approval Process?
Which document provides guidance on the Change Control Order/Document Approval Process?
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What is the effective date of the mentioned work instruction?
What is the effective date of the mentioned work instruction?
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Which document number corresponds to the Processing Customer Requests Work Instruction?
Which document number corresponds to the Processing Customer Requests Work Instruction?
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What role is responsible for reviewing the customer agreement for record retention requirements?
What role is responsible for reviewing the customer agreement for record retention requirements?
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Which individual is responsible for reviewing results in the agreement process?
Which individual is responsible for reviewing results in the agreement process?
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What action is taken if no edits need to be made to the agreement after review?
What action is taken if no edits need to be made to the agreement after review?
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What is the timeframe given to receive a response from the customer regarding the redlined agreement?
What is the timeframe given to receive a response from the customer regarding the redlined agreement?
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Who provides the redlined agreement to the customer?
Who provides the redlined agreement to the customer?
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If the redlined agreement has not been returned to PPC after 90 days, what is the next step?
If the redlined agreement has not been returned to PPC after 90 days, what is the next step?
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What is required before reproducing or disclosing the proprietary document?
What is required before reproducing or disclosing the proprietary document?
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Which type of agreement is the Quality Specialist involved with during the redlining process?
Which type of agreement is the Quality Specialist involved with during the redlining process?
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What happens if the agreements are approved by all parties involved?
What happens if the agreements are approved by all parties involved?
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What is the purpose of creating a folder in the specified directory?
What is the purpose of creating a folder in the specified directory?
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What initial action is required after creating a folder for customer requests?
What initial action is required after creating a folder for customer requests?
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Which document should be reviewed to establish the raw materials used in manufacturing?
Which document should be reviewed to establish the raw materials used in manufacturing?
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Where is the Supplier Compliance Log located?
Where is the Supplier Compliance Log located?
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What should be done if the component part number is not found in the Supplier Compliance Log?
What should be done if the component part number is not found in the Supplier Compliance Log?
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What should the Quality Specialist request if the finished good part numbers are not stated within the request?
What should the Quality Specialist request if the finished good part numbers are not stated within the request?
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What is the example format for the Customer Compliance Request Log number?
What is the example format for the Customer Compliance Request Log number?
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What should the Quality Specialist access to search for completed work orders?
What should the Quality Specialist access to search for completed work orders?
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Study Notes
Purpose and Scope
- This document provides instructions for processing customer requests.
- The requests include, but are not limited to, change notification agreements, non-disclosure agreements, quality agreements, safety data sheets, surveys, forms, conflict mineral, customer compliance requests, including component content inquiries
Responsibilities
- Director of Quality and Regulatory Affairs: Owns the document, implements, reviews the work instructions, and approves quality agreements
- Director of Technical Sales: Reviews and approves sales and non-disclosure agreements.
- Quality Specialist: Logs customer requests, distributes/processes requests, logs closures and maintains records, contacts suppliers for information, updates Supplier Compliance Log.
- Technical Sales Department: Forwards customer requests and supporting documents to the Quality department via email.
- Customer Care Representatives: Forwards customer requests and supporting documents to the Quality department via email.
Definitions
- Refer to DMS #020015 for definitions, acronyms, and terms.
Procedure Overview (Customer Agreement Requests)
- Input: Customer Agreement Request
- Step 1: Log request in Customer Compliance Request Log
- Step 2: Create a folder in the Quality (S:) Drive
- Step 3: Send acknowledgement to the customer
- Step 4: Forward agreement to relevant director for review.
- Step 5: Provide the redlined agreement to the customer.
- Step 6: Save the approved agreement in PPC's eQMS.
- Step 7: Log agreement information in the Customer Quality Agreement Log.
- Step 8: Send completed document to the customer.
- Step 9: Move the file to the completed folder in the Quality (S:) Drive.
- Step 10: Log the completed request, attaching emails to the log.
- Output: Closed Customer Agreement Request and/or Closed Customer Agreement Record
Procedure Overview (Survey and Form Requests)
- Input: Customer Survey or Form Requests
- Step 1: Log request in Customer Compliance Request Log.
- Step 2: Create a folder in the Quality (S:) Drive.
- Step 3: Acknowledge the request to the customer.
- Step 4: (If needed) Contact the customer for clarification.
- Step 5: Save the completed request in PPC's eQMS.
- Step 6: Send the completed request to the customer.
- Step 7: Move the file to the completed folder in the Quality (S:) Drive.
- Step 8: Log the request completion and attach communication to Customer Compliance Request Log.
- Output: Closed Customer Request
Procedure Overview (Component Compliance Requests)
- Input: Regulatory or component information request
- Step 1: Log the request in the Customer Compliance Request Log
- Step 2: Create a folder in the Quality (S:) Drive.
- Step 3: Send an acknowledgement to the customer.
- Step 4: Determine the applicable raw materials
- Step 5: (If 5P located in the Supplier Compliance Log and compliance statement is current) Log the request in the Supplier Compliance Log and request the statement from the supplier. (If not): Escalate the request.
- Step 6: (If supplier compliance log missing) Inititate a log entry for the component in the supplier compliance log.
- Step 7: Ask the vendor for the relevant compliance statement.
- Step 8: Log supplier's info in the Supplier Compliance Log.
- Step 9: Draft and send a statement to the customer.
- Step 10: Save the statement in the Quality (S:) Drive.
- Step 11: Provide the PPC statement to the customer.
- Step 12: Move the request to the completed folder.
- Step 13: Log the completed request to the Customer Compliance Request Log and attach any emails.
- Output: Completed Compliance Request
General Information and Instructions
- Customer requests are received and logged.
- A request is considered closed when an acknowledgement is received or after 24 hours.
- If further clarification is needed, a new request is created.
- Records and logs are maintained following company protocols.
External References
- ISO 13485:2016
- DMS #020015
Safety Precautions
- No safety precautions are specifically noted for this work instruction.
Tools Required
- eQMS (CEBOS)
- Customer Compliance Request Log (SharePoint)
- Supplier Compliance Log (SharePoint)
- File Explorer(S:)Drive\Quality\Document Control
- Customer Quality Agreement Log (SharePoint)
Internal References
- DMS #1005 (Control of Records)
- DMS #1020 (Analysis of Data)
- DMS #2396 (Customer Record Retention List)
- DMS #2398 (Handling Storage and Control of Shelf Life Material)
- DMS #1027 (Change Control Order/Document Approval Process)
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Description
Test your knowledge on the processes and protocols involved in managing customer requests. This quiz covers essential steps from initial log entries to departmental responsibilities. Assess your familiarity with folder naming conventions and compliance management based on the specified document.