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Production and Service Controls Process: 

Part 2 

CAPT Kimberly Lewandowski - Walker 

Senior Regulatory Officer 

Center for Devices and Radiological Health 

U.S. Food and Drug Administration
Course Prerequisites

• Successful completion of the following MDSAP training 

module is a prerequisite to this course: 

– Introduction to the MDSAP Program 

– Overview of the MDSAP Audit Process 

– MDSAP: Management Process 

– MDSAP: Measurement, Analysis and Improvement Process 

– MDSAP: Design and Development Process 

– MDSAP: Production and Service Controls Process: Part 1 
Learning Objectives

• Review the purpose of auditing the Production and 

Service Controls process 

• Explain the audit tasks for Production and Service 

Controls process, Part 2 to include: 

– Description and related Clauses and Regulations

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
Learning Objectives

• Review the purpose of auditing the Production and 

Service Controls process 

• Explain the audit tasks for Production and Service 

Controls process, Part 2 to include: 

– Description and related Clauses and Regulations

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
Purpose of Auditing

• The Production and Service Controls process is audited 

to: 

– Verify that the manufacturer’s processes are capable of 

ensuring that products will meet specifications 

ØIncludes testing, infrastructure, facilities, equipment, and 

servicing

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Learning Objectives

• Review the purpose of auditing the Production and 

Service Controls process 

• Explain the audit tasks for Production and Service 

Controls process, Part 2 to include: 

– Description and related Clauses and Regulations

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
Tasks 1-10

• Audit tasks 1 - 10 were discussed in MDSAP training 

module Production and Service Controls Process, Part 

1 

• Part 2 will commence with audit task 11 

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Task 11

11. Verify that the processes used in production and service are 

appropriately controlled, monitored, operated within 

specified limits and documented in the product realization 

records. In addition, verify that risk control measures 

identified by the manufacturer for production processes are 

implemented, monitored and evaluated.

Clause and Regulation: [ISO 13485:2016: 7.1, 7.5.1, 8.1, 8.2.5; 

TG(MD)R Sch1 P1 2, Sch3 P1 1.4(5)(b)&(e); RDC ANVISA 

16/2013: 2.4, 5.1.1, 5.1.6, 8.2, 9.1; MHLW MO169: 26, 40, 54, 

57; 21 CFR 820.70(a), 820.75(b), 820.250] 

MDSAP Audit Approach

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Task 11

• Additional country - specific requirements: Australia (TGA) 

• Assessing conformity: 

– Confirm that procedures available to production personnel are the 

most current approved revisions 

– Compare work instructions with what is actually being done 

– Compare product acceptance criteria with acceptance activity 

results 

– Review control charts against specified requirements 

Detailed information on how to assess conformity for this audit task 

can be found in the MDSAP Audit Approach, Chapter 6: Production 

and Service Controls, under Task 11 
Task 11

• Links: 

– Design and Development 

ØThe design outputs for a device include 

documents such as diagrams, drawings, 

specifications, procedures, and the production 

processes that are essential to the proper 

manufacturing of the device
Task 12

12. Verify that personnel are competent to implement and 

maintain the processes in accordance with the requirements 

identified by the organization.

Clause and Regulation: [ISO 13485:2016: 6.2; RDC ANVISA 

16/2013: 2.3.2; MHLW MO169: 22; 21 CFR 820.25, 820.70(d), 

820.75(b)] 

MDSAP Audit Approach

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Task 12

• Additional country - specific requirements: None 

• Assessing conformity: 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 6: 

Production and Service Controls, under Task 12 
Task 12

• Links: 

– Management

ØWhen appropriate, review the training records 

for those employees whose activities have 

contributed to process nonconformities
Task 13

13. Confirm the organization has determined the monitoring and 

measuring devices needed to provide evidence of conformity 

to specified requirements. Verify that the monitoring and 

measuring equipment used in production and service has 

been identified, adjusted, calibrated and maintained, and 

capable of producing valid results. 

Clause and Regulation: [ISO 13485:2016: 7.5.1, 7.6; TG(MD)R 

Sch3 P1 1.4(5)(e); RDC ANVISA 16/2013: 5.1.5,5.4; MHLW 

MO169: 40, 53; 21 CFR 820.70(g), 820.72] 

MDSAP Audit Approach

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Task 13

• Additional country - specific requirements: None 

• Assessing conformity: 

– Confirm that the production and test equipment is suitable for its intended 

purpose and capable of giving valid results 

– Review maintenance, control, and calibration procedures for the equipment 

selected for review 

– Verify that the organization made an assessment of the effect of the out-oftolerance situation on in - process, finished, or released devices, based on risk 

Detailed information on how to assess conformity for this audit task 

can be found in the MDSAP Audit Approach, Chapter 6: Production 

and Service Controls, under Task 13 
Task 14

14. Confirm the organization assesses (and records) the validity of 

previous measurements when equipment is found not to 

conform to specified requirements, and takes appropriate 

action on the equipment and any product affected. Verify 

that the control of the monitoring and measuring devices is 

adequate to ensure valid results. Confirm that monitoring 

and measuring devices are protected from damage or 

deterioration. 

Clause and Regulation: [ISO 13485:2016: 7.6; TG(MD)R Sch3 P1 

1.4(5)(e); RDC ANVISA 16/2013: 5.4; MHLW MO169: 53; 21 CFR 

820.72(a)] 

MDSAP Audit Approach

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Task 14

• Additional country - specific requirements: None 

• Assessing conformity: 

– Confirm that the organization has the proper procedures and 

controls in place to preserve the proper functioning of 

monitoring, measuring, and test equipment 

Detailed information on how to assess conformity for this 

audit task can be found in the MDSAP Audit Approach, 

Chapter 6: Production and Service Controls, under Task 14 
Task 15

15. If the selected process is software controlled or if software is 

used in production equipment or the quality management 

system, verify that the software is validated for its intended 

use. Software validation may be part of equipment 

qualification. 

Clause and Regulation: [ISO 13485:2016: 4.1.6, 7.5.6, 7.6; RDC 

ANVISA 16/2013: 5.5.2; MHLW MO169: 5 - 6, 45, 53 (Old: 45, 

53); 21 CFR 820.70(i)] 

MDSAP Audit Approach

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Task 15

• Additional country - specific requirements: None 

• Assessing conformity: 

– Review the software validation documents and records 

– Assess the systems most likely to have an impact on the 

finished device’s ability to meet specified requirements 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 6: 

Production and Service Controls, under task 15 
Task 16

16. Determine if the medical device organization has established and 

maintained a file for each type of device that includes or refers to the 

location of device specifications, production process specifications, quality 

assurance procedures, traceability requirements, packaging and labeling 

specifications, and when applicable requirements for installation and 

servicing. . Confirm that the manufacturer determined the extent of 

traceability based on the risk posed by the device in the event the device 

does not meet specified requirements.

Clause and Regulation: [ISO 13485:2016: 4.2.1, 4.2.3, 7.1, 7.5.8, 7.5.9.1; 

TG(MD)R Sch3 P1 1.4(5) (c),(d),(e) & 1.9; RDC ANVISA 16/2013: 1.2.26, 2.4, 

4.2, 5.2, 6.4; CMDR 9(2), 21 - 23, 52 - 56, 66 - 68; MHLW MO169: 6,7 - 2, 26, 47, 

48 (Old: 6, 26, 47, 48); 21 CFR 820.65, 820.181]

MDSAP Audit Approach

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Task 16

• Additional country - specific requirements: Australia (TGA), 

Brazil (ANVISA), Canada ( HC), United States (FDA) 

• Assessing conformity: 

– Confirm that the required records have been established 

Detailed information on how to assess conformity for this 

audit task can be found in the MDSAP Audit Approach, 

Chapter 6: Production and Service Controls, under Task 16 
Task 16

• Links: 

– Design and Development

ØDuring audit of the Design and Development 

process: 

o Confirm that the essential design outputs for the 

proper functioning of the device have been 

identified 
Task 17

17. Determine if the medical device organization has established and 

maintained a record of the amount manufactured and approved for 

distribution for each batch of medical devices, the record is verified 

and approved, the device is manufactured according to the file 

referenced in Task 16, and the requirements for product release 

were met and documented. 

Clause and Regulation: [ISO 13485:2016: 4.2.1, 7.5.1, 7.5.8, 7.5.9.1, 

8.2.6; RDC ANVISA 16/2013: 3.2, 5.2, 6.4; MHLW MO169: 6, 40, 47, 

48, 58, 59; 21 CFR 820.120, 820.184]

MDSAP Audit Approach

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Task 17

• Additional country - specific requirements: Brazil (ANVISA) 

and the United States (FDA)

• Assessing conformity: 

– Verify that each batch of devices was manufactured in accordance 

with product and production specifications 

– Confirm that the nonconformities were handled appropriately 

Detailed information on how to assess conformity for this audit task 

can be found in the MDSAP Audit Approach, Chapter 6: Production 

and Service Controls, under Task 17 
Task 18

18. If the medical device organization manufactures active or nonactive 

implantable medical devices, life - supporting or life - sustaining devices, 

confirm the manufacturer maintains traceability records of all components, 

materials, and work environment conditions (if these could cause the 

medical device to not satisfy its specified requirements) in addition to 

records of the identity of personnel performing any inspection or testing 

of these devices. Confirm that the organization requires that agents or 

distributors of these devices maintain distribution records and makes 

them available for inspection. Verify that the organization records the 

name and address of shipping consignees for these devices. 

Clause and Regulation: [ISO 13485:2016: 4.2.1, 7.5.9.2, 8.2.6; MHLW 

MO169: 6, 49, 59; 21 CFR 820.65]

MDSAP Audit Approach

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Task 18

• Additional country - specific requirements: Canada (HC), 

United States (FDA)

• Assessing conformity: 

– Confirm that the organization has the necessary systems in 

place to provide for tracking each device to the end user 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 6: 

Production and Service Controls, under Task 18 
Task 19

19. Verify that product status identification is adequate to ensure 

that only product which has passed the required inspections 

and tests is dispatched, used, or installed. 

Clause and Regulation: [ISO 13485:2016: 7.5.8; RDC ANVISA 

16/2013: 6.1.2, 6.4; MHLW MO169: 47 (Old: 47, 50); 21 CFR 

820.86] 

MDSAP Audit Approach

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Task 19

• Additional country - specific requirements: None 

• Assessing conformity: 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 6: 

Production and Service Controls, under Task 19 
Task 20

20. Verify that the medical device organization has implemented 

controls to identify, verify, protect, and safeguard customer 

property provided for use or incorporation into the product. 

Verify that the medical device organization treats patient 

information and confidential health information as customer 

property. 

Clause and Regulation: [ISO 13485:2016: 7.5.10; MHLW 

MO169: 51] 

MDSAP Audit Approach

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Task 20

• Additional country - specific requirements: None 

• Assessing conformity: 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 6: 

Production and Service Controls, under Task 20 
Summary

• Production processes can include: 

– internal controls 

– equipment calibration and maintenance intervals 

– environmental controls 

– personnel controls 

• The purpose of auditing the production and service 

controls process is to verify that the manufacturer’s 

processes are capable of ensuring that products will 

meet specifications 

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Conclusion

• This concludes part 2 of the training module for MDSAP 

process: Production and Service Controls 

• Please continue to part 3 to complete the discussion of the 

audit tasks for the Production and Service Controls process, 

as well as the links to other processes

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