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Overcome the Pitfalls of Design Control Overcome the Pitfalls of Design Control Dan O’Leary CBA, CQA, CQE, CRE, SSBB, CIRM President Ombu Enterprises, LLC [email protected] www.OmbuEnterprises.com 603-209-0600 Design Control Pitfalls Ombu Enterprises, LLC 1 Pitfalls • Design control is required for most medical devices sold in the U.S. In addition, other regulatory venues, such as the EU and Canada, require design control for all devices. • As postmarket surveillance demonstrates, many device problems result from design control deficiencies. • Discuss how the FDA expects you to develop and implement design controls, then transfer product design to manufacturing operations. Design Control Pitfalls Ombu Enterprises, LLC 2 How it Works • We will present four topics related to medical device design control • Each topic will include: – Regulatory requirements – Guidance on what it means – FDA Warning Letters – Questions for discussion • We will have a discussion on the questions • We will ask participants for other issues on the topic Design Control Pitfalls Ombu Enterprises, LLC 3 How to Discuss • Use the microphone so everybody can hear • Bring examples from your experience – Issues raised by FDA Inspections, Form 483, or Warning Letters – Issues raised by Notified Body audits – Issued raised by colleagues – Questions on how things should work • Be polite – Don’t make disparaging remarks about Investigators, Auditors, and others Design Control Pitfalls Ombu Enterprises, LLC 4 The Issues • Design Transfer – Production specifications – Device Master Record (DMR) v. Quality System Record (QSR) – Process validation in design transfer process, – Production software validation in design transfer • Risk Management – RMS that doesn’t use ISO 14971:2007 – FMEA/FMECA is not a risk management system – Content deviations in the EU (EN ISO 14971:2012) – Proliferation of references to ISO 14971:2007 Design Control Pitfalls Ombu Enterprises, LLC 5 The Issues • Design Changes – Design change control before and after design transfer – Production and Process Changes are Design Changes – Change evaluation for 510(k) devices – Configuration management / form, fit & function definitions • Design Verification – The methods and number of items for design verification – Design verification applied to packaging and labeling – Tools to ensure complete input/output coverage Design Control Pitfalls Ombu Enterprises, LLC 6 Design Transfer Design Control Pitfalls Ombu Enterprises, LLC 7 Design Transfer • 820.30(h) Design transfer • Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications. • 7.3.1 Design and development planning • NOTE Design transfer activities during the design and development process ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications. Design Control Pitfalls Ombu Enterprises, LLC 8 Production Specifications • Design Control Guidance for Medical Device Manufacturers • One normally associates the term “production specifications” with written documents, such as assembly drawings, component procurement specifications, workmanship standards, manufacturing instructions, and inspection and test specifications. While these types of documents are widely employed in medical device production, other equally acceptable means of conveying design information exist, and manufacturers have the flexibility to employ these alternate means of communication as appropriate. Design Control Pitfalls Ombu Enterprises, LLC 9 Production Specifications • QSIT – Design Controls – Determine if the design was correctly transferred. • The transfer process must be a part of the design plan. It is not uncommon for the design to be transferred in phases. Production specifications typically consist of written documents such as assembly drawings, inspection and test specifications, and manufacturing instructions. However, they can also consist of electronic records, training materials such as video tapes or pictures, and manufacturing jigs and molds. • Review how the design was transferred into production specifications. Review the device master record. Sample the significant elements of the device master record using the Sampling Tables and compare these with the approved design outputs. These elements may be chosen based on the firm's previously identified essential requirements and risk analysis. Design Control Pitfalls Ombu Enterprises, LLC 10 Warning Letter Axis Health Care, LLC October 20, 2010 • Failure to develop, conduct, control, and monitor production processes to ensure a device conforms to its specifications, as required by 21 CFR §820.70(a). • For example, your firm failed to establish and implement written process control procedures, including standard operating procedure and work instructions to ensure the PACS device conformed to established specifications. • Your response states your firm " ...has procedures in place but has not followed a formal procedure with documentation. We will identify and plan production operations, which directly affect quality to ensure production process, are carried out under controlled conditions...” Design Control Pitfalls Ombu Enterprises, LLC 11 Quality System Record • Sec. 820.186 Quality system record • Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including, but not limited to, the records required by 820.20. Each manufacturer shall ensure that the QSR is prepared and approved in accordance with 820.40. Design Control Pitfalls Ombu Enterprises, LLC 12 Quality System Record • QSR Manual Chapter 8 Device Master Records • Quality system record (QSR) (820.186) or general documents are used for many activities that are essential to operating a manufacturing establishment – these are not specific to any given product even if the company produces only one product. Thus, the quality system record includes general documents such as standard operating procedures (SOPs) and standard quality assurance procedures (QAPs). If the company added another product line, the basic content of these documents would undergo none or only minor changes. • In a typical manufacturing operation, general QSR, SOP, and QAP documents may include the following (partial list): • Employee training procedures Supplier assessment policy • General design control procedures Cleaning procedures • Component inspection procedures Calibration policy • Design review policy/procedure Label review policy/procedure Design Control Pitfalls Ombu Enterprises, LLC 13 Quality System Record • QSR Preamble #189 • One comment stated that general quality system procedures and instructions should not be required in the DMR because the DMR is device specific, and many quality system procedures are not tied to a particular device. • FDA agrees in part with these comments and has developed new Sec. 820.186 Quality system record. This section separates the procedures and documentation of activities that are not specific to a particular type of device from the device specific records. Design Control Pitfalls Ombu Enterprises, LLC 14 Warning Letter X-Ray Support, Inc. September 23, 2011 • Failure to maintain a quality system record (QSR), as required by 21 CFR §820.186. • For example, your firm has not established a quality system record. • Upon request by the investigator for the above referenced procedures, you indicated the requested procedures were located in your head. Design Control Pitfalls Ombu Enterprises, LLC 15 Process Validation • 820.75(a) Process validation • Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented. Design Control Pitfalls Ombu Enterprises, LLC 16 Processes Validation • QSR Preamble #85 • The requirement for testing from the first three production lots or batches has been deleted. While FDA believes that three production runs during process validation (process validation may be initiated before or during design transfer) is the accepted standard, FDA recognizes that all processes may not be defined in terms of lots or batches. The number three is, however, currently considered to be the acceptable standard. Therefore, although the number requirement is deleted, FDA expects validation to be carried out properly in accordance with accepted standards, and will inspect for compliance accordingly. • Revised Sec. 820.30(h) now contains a general requirement for the establishment of procedures to ensure that the design basis for the device is correctly translated into production methods and procedures. Design Control Pitfalls Ombu Enterprises, LLC 17 Warning Letter Michigan Medical Innovations June 5, 2012 • Failure to adequately ensure that, where the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR §820.75(a). • For example, your procedure [require validation]. However, your firm has not validated in-process and finish device testing
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