4 Reasons When is Necessary Preventive Maintenance PM?

In this article, you will learn when is necessary preventive maintenance (PM) according to the FDA requirements.

Preventive maintenance shall be done based on the following 4 reasons and triggers:

1. Manufacturer recommendations,
2. Whenever a change is introduced to equipment that may affect its operation, etc.
3. Risk evaluation of potential failures or FMEA analysis
4. Evaluation of the historical data.

More specifically, preventive maintenance must be performed to any equipment or machinery related to the following areas:

• Specification criteria for raw materials, internally/externally manufactured components, or internally/externally finished products
• Packaging or labeling information, process, or materials.
• The shelf life of raw material, components, or finished products
• Process parameters
• Tools or consumables (i.e. wipes, gloves, shoe covers, etc.)
• Equipment or equipment settings
• Qualified cleanrooms
• Cleaning processes of the manufacturing environment or manufacturing equipment
• Facilities or utilities
• Locations for manufacturing, testing, sterilization, or warehousing
• Environmental conditions of manufacturing, testing, or storage,
• Control of monitoring processes for the manufacturing, testing, storage, or distribution environment
• Suppliers or external manufacturers
• Line re-configuration as it relates to operators changing from a seated to standing position, updates to the line and station layouts, or re-sequencing of process steps
• Throughput time as it relates to changes to the material storage time between processes
• Product handling techniques as it relates to material storage and conveyance
• Working with multiple lots at different stations.
• Layouts in areas of product handling like manufacturing and warehouse
• Any change that can potentially impact form, fit or function, and the quality of the product.
• Changes related to supplied items, raw material, components, or finished products in regards to:
  • manufacturing or assembly processes
  • control or monitoring processes
  • cleaning processes
  • product handling
  • inspection or release processes
  • configuration check inspections
  • sample size or sampling plans
  • method of testing (e.g. physical, analytical, microbiological)
  • packaging or labeling processes
  • sterilization process
  • storage, shipment, or distribution processes.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

SUBSCRIBE AND FOLLOW US TO LEARN MORE.

For more details about when is necessary preventive maintenance, follow us.

Three (3) Options to Create Document Control Management DCM Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Document Control Management DCM procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.

Silver Option. We Can Bring You Formal Training about when is necessary preventive maintenance (PM).

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

Get in compliance today, CONTACT US (Hablamos Español)

REFERENCES: WHEN IS NECESSARY A PREVENTIVE MAINTENANCE

STATUTORY AND REGULATORY REQUIREMENTS – 

TITLE 21–FOOD AND DRUGS

PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart D–Equipment

Sec. 211.67 Equipment cleaning and maintenance.

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67

TITLE 21–FOOD AND DRUGS

PART 820 Medical Devices

Subpart G–Production and Process Controls

Sec. 820.70(g) Production and process controls.

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

For more information about when is necessary preventive maintenance, refer to:

httpss://www.fda.gov/media/73942/download

httpss://www.fda.gov/media/94076/download

httpss://www.fda.gov/media/70106/download

httpss://www.fda.gov/media/102633/download