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Production and Process Controls

Slide 1 

Hello, my name is Vidya Gopal, and I'm a Consumer Safety Officer in the Division of Industry and 

Consumer Education at FDA's Center for Devices and Radiological Health. In this presentation, I'll 

discuss the topic of Production and Process Controls. I have experience in developing processes and the 

controls associated with them when I worked as an engineer in industry. I have also worked as a 

compliance officer at the FDA and understand the importance of production and process controls in 

producing a quality product. I hope to bring a balanced perspective from both sides to my discussion 

on production and process controls. 

Slide 2 

Production and process controls are a key part of the Quality System for medical device manufacturing. 

They help ensure that you manufacture products that meet pre-determined specifications and build 

the products you said you were going to build.

Slide 3

Here are the learning objectives for this module. By the time we are finished, I will (1) explain how 

production and process controls relate to the overall Quality System, (2) describe the general aspects of 

production and process controls, (3) describe the aspects of inspection, measuring, and testing 

equipment, and (4) define the concept of process validation.

Slide 4

Let us start at this diagram of the Quality System. This shows the 7 major subsystems of the quality 

system, with management at the center of it all. Today's talk will focus on the Production and Process 

Controls subsystem.

Slide 5

Under the production and process control subsystem, we will cover production and process controls; 

inspection, measuring and test equipment; and process validation.

Slide 6

Let's begin with the topic of production and process controls, which is outlined in the Code of Federal 

Regulation under 21 CFR 820.70.

Slide 7

Manufacturers need to develop, conduct, control, and monitor production processes to ensure that a 

device conforms to its specifications.

Slide 8

Let us consider an example of a common process - package sealing. In order for the package to be 

sealed correctly, the criteria for temperature, pressure and time must be established. And this process 

then has to be monitored to make sure it is functioning correctly. 

Slide 9

If deviations from device specifications could occur as a result of the manufacturing process, there are 

5 things you are required to do.
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Slide 10

One, have instructions, standard operating procedures or SOPs, and methods that define and control 

the production. Two, include how the process will be monitored and controlled during production. 

Three, include the reference standards or codes against which to compare the process. Four, approve 

processes and equipment for the specific purpose. And finally, define the criteria for workmanship. 

This may be samples or photos of acceptable and unacceptable product.

Slide 11

In dealing with production and process changes, manufacturers should establish procedures for 

changes to a specification, method, process or procedure. You should verify, or where appropriate, 

validate these changes before implementation. And these changes need to be approved. Document 

change control addresses the administrative aspects of a change. Design and production and process 

change controls involve the technical work associated with the change, mainly proving with objective 

evidence that the change will not affect the ability to produce a device that meets user needs and 

intended uses consistently. The main intent is to maintain control throughout.

Slide 12

We are going to talk about environmental controls next. If environmental conditions have an adverse 

effect on product quality, then you need to have environmental controls. The type of controls or the 

changes to these controls are based on risk. 

Slide 13

Typical environmental conditions that may require control are: particles, humidity, air pressure, flow, 

filtration, and ionization, temperature, lighting, sound and vibration.

Slide 14

Let us consider a Rinsing process. If you are going to be using water to rinse the product, then you need 

to know the source of that water, to help you determine the type of controls required to make sure 

there are no harmful residues left behind. 

Slide 15

Periodically inspect environmental control systems to verify that the system, including equipment, is 

adequate and functioning properly. Inspection of the control systems allows manufacturers to detect 

issues before substantial product impact can occur. These environmental control activities need to be 

documented and reviewed. 

Slide 16

For example, review the humidity charts in the facility to make sure they are within the operating 

window. Check the electrostatic discharge, or ESD, station grounding daily to prevent inadvertent ESD 

damage.

Slide 17

Next, we're going to talk about Personnel. Manufacturers need to establish and maintain requirements 

for the health, cleanliness, personnel practices, and clothing of personnel. This is especially important if 

contact between people and product or work environment could have an adverse effect on the quality 

of the device.
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Slide 18

Companies typically have clothing restrictions or require the use of uniforms, especially with respect to 

cleanrooms or electronic products. Examples of appropriate clothing are hair nets and smocks. Most 

manufacturing facilities will have their employees use hair nets and smocks, so that no contaminant 

gets onto the product. Another common requirement is to not permit food or drink in manufacturing 

areas. 

And finally, companies often have procedures on how to address illnesses while at work, such as 

respiratory illness or skin conditions. The point to note here is that FDA is interested in how you protect 

your medical device during manufacturing. The protection of the employees is under the purview of 

another government agency, the Occupational Safety and Health Administration, or OSHA.

Slide 19

Before going forward, I want to provide a short background on the preamble to the Quality System 

Regulation. When proposed rules are published, stakeholders have an opportunity to comment and 

ask questions. FDA then responds to those comments and questions in the preamble to the regulation. 

The preamble is very important as it explains the intent of FDA at the time the rule was published. For 

more information about the preamble to the quality system regulation, please watch the CDRH Learn 

module on the Quality System Overview.

Slide 20

Preamble Comment #129, contains some clarification regarding personnel. It says that the 

requirements will not permit unclean or inappropriately clothed employees, or employees with medical 

conditions, to work with devices where these conditions could have an adverse effect on product 

quality. It re-iterates that the procedures must also address acceptable clothing, hygiene, and 

personnel practices, if contact between personnel and product or environment could have an adverse 

effect on product quality.

Slide 21

There needs to be procedures that address maintenance and other personnel who are required to 

work temporarily under special environmental conditions. They need to be appropriately trained or 

supervised by a trained individual.

Slide 22

For example, when maintenance workers or janitorial staff enter a cleanroom, we need to make sure 

that they follow the procedures of the cleanroom like gowning and entering, bringing in materials and 

such.

Slide 23

Next is Contamination Control. Establish and maintain procedures to prevent contamination of 

equipment or product by substances that could have an adverse effect on product quality. 

Slide 24

One of the examples that comes up often is cardboard boxes in cleanrooms. If you deem that the 

particulate from the cardboard boxes is going to contaminate your product, then you should not have 

cardboard boxes in the cleanroom. You make the determination of what affects your product and have 

steps to mitigate it.
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Slide 25

The preamble provides some more clarification on cleaning. Contamination control must include 

establishing and maintaining adequate cleaning procedures and schedules. It makes the connection 

between Production and Process Controls and Personnel in 820.25. Personnel requires that employees 

should have a thorough understanding of their job functions including cleanliness and sanitation 

procedures.

Slide 26

21 CFR 820.70(f) addresses Buildings. Buildings should be of suitable design and contain sufficient 

space to perform necessary operations, prevent mix ups, and assure orderly handling.

Slide 27

Next is Equipment. Equipment is the broad category of items necessary to produce a product. All 

equipment used in the manufacturing process must meet specified requirements and be appropriately 

designed, constructed, placed and installed to facilitate maintenance, adjustment, cleaning and use. 

This means that all equipment is subject to an installation qualification. The extent of the installation 

effort can be based on Risk. 

Slide 28

You need to establish and maintain schedules for the adjustment, cleaning and other maintenance of 

equipment to ensure that manufacturing specifications are met. A good place to start is with the 

equipment manufacturer's instructions for maintenance activities and intervals, and then tailor it to 

your specific operation. These maintenance activities should be documented including the date and 

individuals performing the maintenance activities.

Slide 29

Once you establish the maintenance schedules, then conduct periodic inspections to ensure adherence 

to the maintenance schedules and document inspections including the date and individuals conducting 

the inspections.

Slide 30

Post any inherent limitations or allowable tolerances visibly on or near the equipment requiring 

periodic adjustments or make this information readily available to the persons performing the 

adjustments. This requirement emphasizes that personnel using the equipment need to know what is 

and is not allowable. Every equipment dial doesn't necessarily have to be used to its full range. 

Slide 31

We will next talk about manufacturing material. Let's first review the definition. Manufacturing 

material is defined as any material or substance used in or used to facilitate the manufacturing process, 

a concomitant or byproduct material produced during manufacturing that was not the design or 

intent of the manufacturer.

Slide 32

Comment 26 in the Preamble helps to clarify this definition. "Concomitant material" refers to those 

material or substances that naturally occur as part of the material or during the manufacturing process 

which are intended to be removed or reduced in the finished device.
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Slide 33

If the manufacturing material is expected to have an adverse effect on product quality, then establish 

and maintain procedures to remove the manufacturing material.

Slide 34

For example, the allergenic or adverse proteins that occur in natural rubber latex components of 

medical devices are concomitant materials. These must be reduced or removed from the finished 

devices.

Slide 35

The Use and Removal of Manufacturing Material may be part of another procedure. For example, in a 

coating process, Use may be part of a mixing procedure. Procedures should have an associated data 

form for recording values. And finally, SOPs, data forms and purchasing requirements are part of the 

device master record.

Slide 36

We will next talk about Automated Process. If a computer software is used as part of production or the 

Quality System, then you should validate it for its intended use. This means if a system is capable of 

doing 100 different functions, you do not need to validate all 100 of them. 

Validate for your intended use and according to an established protocol. Software changes must be 

validated before approval and issuance. This requirement is difficult to meet if systems are set up to 

automatically download updates from vendors. Another common mistake is equipment maintenance 

suppliers that update software during their preventive maintenance visits. Finally, document your 

validation activities and results.

Slide 37

This slide lists several examples of automated processes. These include: an injection molding process, 

statistical process control software, complaint tracking software, inventory tracking, and document 

control.

Slide 38 

In the next section, we will talk about Inspection, Measuring and Test Equipment as outlined in 21 CFR 

820.72.

Slide 39

Ensure all inspection, measuring, and test equipment is suitable for intended purposes and capable of 

producing valid results.

Slide 40

Why do we need to control equipment? Inspection, measuring and test equipment is used to evaluate 

whether product is conforming or nonconforming during design, process validation and routine 

production. The equipment must provide valid results if the evaluation is to be meaningful.

Slide 41

We need to make sure equipment is routinely inspected, checked, maintained and calibrated. These 

procedures should also address equipment handling, preservation, storage. These activities need to be 
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documented. One thing to keep in mind is that when using an electronic system to track calibration 

status, that system is subject to 820.70(i) - automated process validation, as discussed earlier.

Slide 42

Calibration is further addressed in the regulation. A manufacturer is required to establish procedures, 

including specific directions and limits for accuracy and precision. To produce valid results, the 

equipment should be accurate and precise. Accurate means how close the measured value is to the 

actual value. Precise means the proximity of multiple measurements to each other - for example, how 

close they are to each other. There are different ways to establish equipment capability. "Gage 

Repeatability and Reproducibility", or Gage R&R, is one of the ways to do it. It evaluates variability 

between people and between equipment to understand typical performance. 

Slide 43

The procedures must include provisions for remedial action to reestablish the limits and evaluate for 

adverse effect on device quality. When you are evaluating for adverse effects, consider all usage since 

last known good condition. Records also need to include "as found" condition when submitted for 

calibration in order to recognize need for remedial action.

Slide 44

Calibration is always performed against a known physical reference also known as the calibration 

standard. Calibration standards must be traceable to national standards, international standards, or 

independent reproducible standards. Independent reproducible standards apply if the manufacturer of 

the equipment provides a standard for calibration purposes. 

Slide 45

Calibration records must include equipment identification, calibration dates, individuals performing 

each calibration, and the next calibration date. These Records must be posted on or near equipment. 

Proximity of records facilitates operator verification that equipment is in calibration and ok to use.

Slide 46

The next section is Process Validation covered by 21 CFR 820.75.

Slide 47

Process validation means establishing by objective evidence that a process consistently produces a 

result or product meeting its predetermined specifications.

Slide 48

Since process validation is a vast subject and a very important one, we have an entire module 

dedicated to that. Please visit our CDRH Learn Module on process validation for more information.

Slide 49

Additional information on the Quality System, its Preamble, and the FDA Inspection Guide may be 

found at the links on this slide.

Slide 50

Let's summarize this module. First, we showed the relationship of production and process control to 

the overall Quality System. We then discussed the general aspects of Production and Process Controls 
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and described the aspects of inspection, measuring, and testing equipment. And finally, we introduced 

the concept of Process Validation.

Slide 51

In concluding this presentation, I now ask you to take on the following Call to Action:

Establish your Production and Process Controls so you may manufacture products that meet your 

specifications.

Slide 52

This presentation and other helpful videos and educational resources may be found at CDRH Learn. 

We encourage you to use these and other industry education resources we've developed especially for 

you, as shown on this slide. Of note, for comprehensive regulatory information, please contact CDRH's 

Division of Industry and Consumer Education. We look forward to helping you. Thank you for watching 

this program.

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