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Title: Product/Process Change Intent Notification (PAIN) Document Number: FMQA0038 Revision: PAIN#: Change Type: PCIN1412001 Major A X Minor PRODUCTS AFFECTED: Date: December 12, 2014, Attachments:
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How to fill out productprocess change notification pcn

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How to fill out product process change notification (PCN):

01
Begin by gathering all necessary information about the product process change that you wish to implement. This includes details such as the specific change being made, the reason for the change, and any relevant documentation or data.
02
Clearly identify the product for which this change notification is being filled out. Provide the product name, model number, and any other relevant identification information.
03
Next, outline the specific details of the process change. This may include changes to manufacturing methods, materials, suppliers, or any other aspect of the production process. Clearly describe the change and its intended impact.
04
Consider the potential effects of the process change on the product. Identify any critical parameters, specifications, or performance criteria that could be affected by the change. Assess whether the change could have any potential risks or implications for the product's functionality or quality.
05
If applicable, include any testing or validation results that support the implementation of the process change. This could include data from quality control tests, prototypes, or any other relevant testing methodologies.
06
Consider any regulatory or legal requirements that may be relevant to the process change. Ensure that the change complies with all applicable standards, regulations, and certifications.
07
In the PCN, clearly state the desired implementation date for the process change. Provide a reasonable timeframe that allows for all necessary preparations and adjustments to be made.
08
If there are any specific instructions or considerations for the implementation of the process change, include them in the PCN. This could include instructions for production line modifications, tooling changes, or any other details that are critical for the successful implementation of the change.

Who needs product process change notification (PCN):

01
Manufacturers: Manufacturers of products need PCNs to communicate updates or modifications to their production processes. This allows them to ensure that the changes are implemented correctly and in compliance with relevant regulations.
02
Suppliers: Suppliers of components or materials used in the production of a product need to be informed of any changes in the product process. This allows them to make any necessary adjustments to their own manufacturing processes or sourcing strategies.
03
Quality control departments: Quality control departments within an organization need PCNs to assess the potential impact of process changes on product quality. This enables them to perform the necessary tests and evaluations to ensure that the product continues to meet the required standards.
04
Regulatory bodies: Regulatory bodies may require PCNs for certain types of products or industries to ensure compliance with regulations and standards. This enables them to review and approve any changes that may affect the safety or efficacy of the product.
05
Customers: In some cases, customers may request or require PCNs to be provided before they purchase or continue using a product. This allows them to stay informed about any changes that could affect the product's performance or functionality.
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PCN is a notification that informs stakeholders about any changes in the product or manufacturing process.
Manufacturers, suppliers, or any entity making changes to a product or manufacturing process are required to file a PCN.
To fill out a PCN, one must provide details about the changes made, the reasons for the changes, potential impact on quality and performance, and any necessary supporting documentation.
The purpose of a PCN is to ensure transparency, communication, and compliance with regulations regarding changes in products or manufacturing processes.
Information such as the nature of changes, reasons for changes, impact assessment, timeline, and any supporting data or documentation must be reported on a PCN.
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