Question

MERMED Inc. is a medical device manufacturer.

The company’s headquarters is located in Houston, Texas. It is a global leader in developing, manufacturing, selling and servicing diagnostic imaging and therapeutic medical devices used to diagnose and treat cardiovascular and other diseases. MERMED earned $300 million of revenue in 2015, while employing more than 10,000 people worldwide. One of it’s manufacturing plants is located in Dingle, Co. Kerry, Ireland. Tom Jones is the plant manager at the Dingle facility.

The Dingle site runs 12 hour shifts, 7 days a week. It has 1000 employees. It manufactures a variety of of medical devices (including Class III devices). A number of it's products are sold in the US and European markets. The facility has a Quality Management System in place. Their Quality Management System is in compliance with ISO 13485:2016 and 21 CFR 820. Their facility is frequently audited by Notified Bodies and the FDA.

The site was recently audited by corporate. The corporate auditing team were checking the site's compliance with ISO 13485:2016 and 21 CFR 820. The auditors found a number of potential non-conformances to  ISO 13485:2016 and 21 CFR 820.

You must complete 4 tasks (for each of the 5 incidents/questions):

1.   Review each of these potential non-conformances (5 incidents in total)

2. Determine if they are non-conformances against the requirements of the ISO13485:2016 AND 21 CFR 820.

3. If they are non-compliances, write down the specific clause numbers in ISO 13485:2016 AND specific section number of 21 CFR 820 which is applicable (write down the main clause/section in each regulation that the non-compliance is against).

Note:  ISO 13485:2016 and 21 CFR 820 are available in the "Additional Resources" section, under the section heading "Quality Systems Regulations (EU and US)" (contained within Section A Medical Device Regulatory Affairs).

4. Briefly EXPLAIN your decision in 100-170 words.

QUESTION 4

The operation of a weighing scale (equipments ID 186749) was reviewed by the inspector in the Box Packing section. The weighing scale was in use during the current shift. The operating procedure (SOP18654) for the scale states that it must be calibrated at the beginning and end of each shift. The operating procedure states that that the calibration of the scales is recorded in a log book(Calibration Log for ID 186749 ). The inspector asked to review this log book. The maintenance technician who was interviewed said that the log book was held by the maintenance technician on the night shift and he always kept it in his desk drawer which was locked.

Answer 1

1. Review each of these potential non-conformances (5 incidents in total)

Non-conformance: any deviation from work standards, practices, procedures, regulations, management system performance etc. that could either directly or indirectly lead to injury or illness, property damage, damage to the workplace environment, or a combination of these

1. Determine if they are non-conformances against the requirements of the ISO13485:2016 AND 21 CFR 820.

plan, do, check and act (PDCA) is the mantra of the Deming disciples, but does anyone know what should be in your quality system plan template. Everyone focuses on the steps–the “What’s.” Unfortunately, people forget to include the other important pieces of an all inclusive quality system plan template. Why? When? Who? and How much?

The table in the template is an example of “What?” steps to perform, but it is specific to my procedures. You will need to revise the table to reference your own procedures and the changes you make will be specific to your quality system plan. The other sections of the template tell you what needs to be included in that section, but I did not provide examples for those sections.

The purpose section of the quality system plan template answers the question of “Why?” You need to specify if the purpose of your quality system plan is compliance with new and revised regulatory requirements, preventing recurrence of quality issues or maybe a faster development cycle. The purpose section of the plan also provides guidance with regard to the monitoring and measurement section of your quality system plan template.

Most changes have deadlines. In the case of ISO 13485:2016, there will be a 3-year transition period, but most companies establish internal goals for early implementation by the end of the fiscal year or the end of a financial quarter. Some of the changes can be made in parallel, while other changes need to be sequential. Therefore, there may be specific milestones within the quality system plan template that must be complete by specific dates. These dates define “When?” the steps in the quality system plan must be implemented

Monitoring the progress of your plan ensures successful implementation of the plan. Sometimes things don’t work as planned and corrections need to be made. Additional resources might be needed. The plan may have been too optimistic with regard to the implementation time required. I recommend assigning one person the task of retrieving team status reports from each of the teams and consolidating the team reports into an overall progress report

1. If they are non-compliances, write down the specific clause numbers in ISO 13485:2016 AND specific section number of 21 CFR 820 which is applicable (write down the main clause/section in each regulation that the non-compliance is against).

Any instrument, apparatus, implement, machine, appliance,

implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices, providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means

SO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

4. Briefly EXPLAIN your decision in 100-170 words.

QUESTION 4

The operation of a weighing scale (equipments ID 186749) was reviewed by the inspector in the Box Packing section. The weighing scale was in use during the current shift. The operating procedure (SOP18654) for the scale states that it must be calibrated at the beginning and end of each shift. The operating procedure states that that the calibration of the scales is recorded in a log book(Calibration Log for ID 186749 ). The inspector asked to review this log book. The maintenance technician who was interviewed said that the log book was held by the maintenance technician on the night shift and he always kept it in his desk drawer which was locked.

It always surprises us when we discover an alcohol testing program that does not utilize a logbook for their EBT (Evidential Breath Tester). This missing documentation can lead to problems if faced with an audit or legal proceedings. Programs which fail to document their quality assurance practices properly are out of compliance with 49 CFR Part 40.233(c)(4). The term “logbook” in this context refers to a Calibration Logbook. A Calibration Logbook keeps records of accuracy checks, calibrations, and instrument maintenance. This is a different document from a BAT logbook, which holds records of every test and function conducted with a particular device.

A well maintained logbook provides proof that the instrument has been maintained in accordance with the standards put forth in both 49 CFR Part 40 and the approved QAP for that device. The logbook is the best way to demonstrate that your program is compliant and that your EBT is providing accurate results. Having a history of successful accuracy checks in the logbook builds a record of reliability for the device. Showing that your EBT device consistently passes its checks over extended periods reinforces this dependability.

Anytime an audit occurs there exists a strong probability that your logbook will be closely examined. This is regardless of the agency. Your logbook will likely become a target of subpoena should you ever have to defend the result of a breath alcohol test. In either situation, the logbook is brought under close scrutiny.