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820.181 Device master record.

Each manufacturer shall maintain device master records (DMR`s). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:

(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;

(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;

(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;

(d) Packaging and labeling specifications, including methods and processes used; and

(e) Installation, maintenance, and servicing procedures and methods.

Interpretation:

Device master record (DMR) is the term used in the Quality System (QS) regulation for all of the routine documentation required to manufacture devices that will consistently meet company requirements. Section 820.3(j) of the QS regulation defines device master record as a compilation of records containing the procedures and specifications for a finished device. The detailed requirements for device master records are contained in section 820.181, as well as throughout the regulation.

The definition for design output in 820.3(g) gives the basis and/or origin of the device master record for all Class II and III devices as follows:

Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.

For some devices, many of the design output documents are the same as the device master record documents. Other device output information is used to create a DMR drawing such as for a test or an inspection procedure. Figure 6.1 shows the close relationship between design output and the device master record.

Section 820.181, Device Master Record, lists some typical documents in a DMR as follows:

The DMR for each type of device shall include, or refer to the location of, the following information:

(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;

(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;

(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;

(d) Packaging and labeling specifications, including methods and processes used; and

(e) Installation, maintenance, and servicing procedures and methods.

The definition for Design Output 820.3(g) and requirements for Design Output 820.30(d) do not apply to most Class I devices. Therefore, the requirements for the DMR for most Class I devices are in 820.181 Device Master Record. Of course, a manufacturer of Class I devices may use the design output sections of the GMP as guidance.

However, almost all sections of the QS regulation have requirements related to the device master record. The device master record contains specifications for the device, accessories, labeling, and packaging, and contains a full description of how to procure the components and manufacture the device including specifications for facilities, environment, and production equipment. In addition to the device specifications, a device master record contains documents that cover typical manufacturing activities such as:

• procurement,
• assembly,
• labeling,
• test and inspection,
• packaging, and
• where applicable, sterilization.

Note that the listed activities and records or documents are required to produce any product ­­ medical, industrial, or consumer. There is nothing special about device master records except the name!

Also, note that in common usage, the term "device master record" refers to the total record or any of its individual records. Therefore, the term is singular for the total record, singular for a single document, and plural for a group of single documents. The term also may refer to an original record or a copy of a record.

Device master records should be technically correct, contain and/or reflect the approved device and process designs, be under change control, contain the release or other control date, contain an approval signature, and be directed toward the intended user. These requirements are in the QS regulation because the device master record is the "beginning and end" of a product ­­ errors in the device master record will have a serious impact on the state ­of­ control of the manufacturing operation and may have a serious impact on the safety and performance of the device. The device master record should be accurate and complete because the essence of the QS regulation is a quality system based on designing a device to meet user needs, documenting the design and production procedures in the device master record and then producing a finished device that meets the device master record requirements. Thus, the device master record shall accurately reflect the device intended to be produced by a manufacturer.

Document For Intended Employees

The content, style, language, graphics, etc., of device master records should be directed toward the needs of the intended employees and, if the record is a specification or text for labeling, it should be directed toward users. A failure to consider the intended user leads to confusion and means that the company has not achieved the state ­of­ control intended by the QS regulation. Therefore, applicable records should be directed toward the needs of procurement, processing, and test/inspection personnel, rather than the needs of drafting, technical services, or product development departments. Likewise, installation instructions should be directed to installers. Labeling is often prepared by the same employees that draft device master records; and, these employees should also be aware that labeling shall meet the needs of the user as directed by 21 CFR 809.10, 801.6 and 820.30.

In any manufacturing activity such as assembly, labeling, processing, testing, etc., achieving and maintaining a state of control  is enhanced by appropriate personnel knowing:

• what task is to be done,
• how to do the task,
• who is to do the task,
• what task is being done, and
• what task was done and/or the results of the activity.

In order for employees to perform a job correctly, they should know exactly what is to be done and exactly how to do the work. Section 820.181 requires that what is done be documented in the device master record. The device master record also contains test and inspection procedures and data forms that are used to help determine and record what was done.

Documents that instruct people how to fabricate, assemble, mix, label, test, inspect, etc., or how to operate equipment should:

• be directed toward the needs of the employees who will be using them and not directed toward the drafts-person or designer;

• match the tools and equipment to be used;

• be correct, complete, and current; and

• depend on part numbers and basic drawings to transfer information rather than almost photographic type drawings.

If a component is changed, the representations on pictorial/photographic type drawings are no longer correct and may be very confusing to employees, particularly new employees.

The how­ to ­manufacture instructions should be adequate for use by the intended employees and correct for the intended operation. In the medium­ to­ large company, the instructions tend to be extensive technical (engineering) drawings and written procedures. In any company, particularly small manufacturers, the work instructions may take several forms as discussed below.

• Engineering drawings may be used if employees are trained to read and use them. Some of the how­to information comes from employee training rather than from drawings.

• Assembly drawings may contain parts list and quality acceptance criteria. A separate quality acceptance test and/or inspection procedure is not always necessary. An example of an engineering drawing for assembling a handle is exhibited at the end of this chapter. This drawing also includes some of the quality acceptance criteria for evaluating the handle in Notes 1 and 2. The parts list for the handle is on the page after the assembly drawing. Some manufacturers that manufacture simple devices use large sheets of paper for assembly drawings and include the parts list on it. The combination drawing results in instant availability of the parts list and reduces the number of drawings to be controlled. An example of an engineering drawing for assembling a cable and the associated parts list follows the handle assembly drawings.

• Exploded­view drawings are used when employees cannot read plan­view engineering drawings. Exploded­view drawings tend to be more "how to" than plan­view drawings. Exploded­view drawings are expensive to draft ­­ in some cases it may cost less to teach employees how to read and use ordinary plan­view drawings.

• Step­ by ­step written procedures may be used to detail how to perform specific tasks with check ­off blanks to show that each specific task was performed. This type of procedure is commonly used for critical operations and where there is little or no visual indication of what has been done, such as for cleaning operations and for mixing chemicals.

Documentation may be supported by production aids such as labeled photographs, video tapes, slide shows, sample assemblies, or sample finished devices. All of these perform device master record functions and should be identified, and be current, correct, and approved for the intended operation.

The most commonly used aids are models or samples. There are two conditions that should be satisfied in order to use these aids. First, a written specification for the sample shall be contained in the device master record. This specification, of course, may be the same as the specification for the assembly or finished device to be manufactured. This specification shall be subject to a formal change­ control procedure. Even though a model is available, the specification is needed for present and future product development, and for production control purposes. Second, the sample should:

• adequately reflect the device master record specification;

• be identified as an approved acceptable representative sample, which means it shall meet the company required workmanship standards; the sample need not be a working model if the nonworking condition is not misleading to employees being guided by the sample; and

• when appropriate, contain or be tagged with a drawing number, revision level, and control number (lot, serial, batch).

A card or tag as shown in the exhibits or an equivalent card may be used to identify and help control the use of samples of assemblies or finished devices. Such tags are usually covered by a clear plastic pouch and attached to the model or sample.

Samples and other aids such as photographs are subject to normal wear and tear in a production environment. Therefore, such aids should be adequately protected by a suitable means such as being located in a protected area, or covered by a protective pouch or container. Production aids should be periodically audited to make sure they continue to be suitable for the intended use. Section 820.100 contains requirements for corrective action. Corrective action may involve the use of samples, changes to the samples, or changes in the control of the samples.

Adequate Information

Although a manufacturer tries to document for the intended employees, there is a need to audit periodically to see how well the goal is being met. There are various means of determining if information in the device master record, production tools, and other production elements are adequate for a given operation and associated employees. These include analyzing the:

• assistance required by new employees;
• assistance required when a new device is introduced into production;
• confusion and hesitation;
• information exchanged among employees;
• "homemade" documentation drafted by the line employees;
• rework;
• products produced (productivity);
• complaints from departments that subsequently process the device; and
• customer complaints.

If any of these factors persist and are out of line with industry norms or with the previous production experience, then the manufacturer should take corrective action. Management shall review the quality system as directed by 820.20 and, thus, be aware of device quality problems or quality system problems such as listed above. The corrective action may include changes in supervision or documentation, adding new documentation, modifying the design, using different tools, modifying the environment, etc.

Preparation and Signatures

A separate device master record is required for each type or family of devices. Also, a separate device master record may be needed for accessories to devices when these are distributed separately for health care purposes. Such accessories are considered to be finished devices. In practice, if the device and accessories are made by the same manufacturer, the device master record for the accessory may be incorporated into the device master record for the primary device.

Within a family of devices, variations in the family may be handled by dash number extensions on drawing and procedure numbers. Usually, a top assembly or other major drawing contains a table/list of the devices in the family and lists the variable parameters for each member of the family.

Section 820.40 of the QS regulation requires that an individual(s) be designated to: review, date, and approve all documents required by the QS regulation including the device master record and authorize changes. An individual(s) with the necessary technical training and experience shall be designated to prepare and control device master records. In addition to requiring approval signatures on device master records, the QS regulation requires individual identification for a few other activities. For convenience, these activities along with the section numbers that require them are listed in Table 8.1.

Table 8.1 GMP ACTIVITIES REQUIRING INDIVIDUAL IDENTIFICATION

The list is self ­explanatory except for audit certification. When a manufacturer certifies in writing to FDA that quality system audits have been performed, the certification letter is signed by management having responsibility for the matters audited. Also note that the records in 820.70, 820.72, 820.80, 820.90(b), 820.120(b) and 820.160 are not part of the device master record but, instead, are part of the device history record (DHR). Records in 820.198(b) are part of the complaint files.

If a record that requires a signature is maintained on a computer, it is best if the designated individual(s) maintains an up­to­date signed printout of the record. Where it is impracticable to maintain current printouts, computer­ compatible identifiers may be used in lieu of signatures as long as there are adequate controls to prevent improper use, proper employee identification, inaccurate data input, or other inappropriate activity. If identifiers such as coded badges and equipment keys are not controlled (i.e., not restricted to designated employees), then these will not meet applicable GMP "signature" requirements.

Location of Records

Device master records shall be stored at the manufacturing establishment or at other locations (820.180) that are reasonably accessible to company employees responsible for the manufacturing activities and accessible to FDA investigators. Appropriate records may be maintained in computer data banks if the records are protected, change controlled, and readily accessible for use by responsible employees at all relevant facilities. It is acceptable for a manufacturer to maintain records on microfilm and discard the original hard copies. Microfiche and/or microfilm reductions may be used in lieu of original record retention if the following conditions are met.

• All reductions shall be readily available for review and copying by FDA investigators and designated company personnel at any reasonable time.
• All necessary equipment shall be provided for viewing and copying the records.
• Reproductions shall be true and accurate copies of the original record.

If the reproduction process results in a copy that does not reveal changes or additions to the original record, the original should be retained. In this situation, the reproduced copy and any image shown on a viewing screen should note any alteration from the original and indicate that the original record is available.

By maintaining the device master record, complaints and other records required by the QS regulation at the manufacturing establishment or other reasonably accessible location, responsible officials of a company can exercise control and accountability over the entire design, manufacturing, and post marketing activities and, thereby, maximize the probability that the finished device conforms to its design specifications. This GMP requirement helps assure that responsible officials at the manufacturing establishment have ready access to those documents essential for producing devices and for conducting self­inspections, complaint investigations, failure analyses, audits, and corrective action.

The device master record is a single source document or file. Portions of this file may be kept in various locations. A device master record may exist as:

• one or more files or volumes of the actual records containing the information required by the QS regulation;

• a reference list of such documents and their location; or

• any combination of actual documents and/or reference lists.

These documents shall contain the latest DMR revisions, be signed, and be dated to show they have been checked for adequacy and approved for use (820.30, 820.40 and 820.181).

The QS regulation allows use of reference lists as a means to reduce the duplication of records, particularly duplication of general documents such as standard operating procedures (SOP's). General SOP's (not directly related to a product or process) however should be made a part of the quality system record (QSR) (820.186).

Use of a reference list also allows filing of device master record documents at several convenient locations. If the device master record contains a list of documentation, the actual documents shall be available for employee use and FDA inspection at the manufacturing site or other reasonably accessible locations. As noted above, this is a key and important GMP requirement. Typical locations of various device master records are shown in Table 8.2.

When performing an inspection of a company, FDA investigators shall have access to actual records for review and copying during reasonable business hours. FDA investigators review these records to determine if a manufacturer is complying with the QS regulation and with the Food, Drug, and Cosmetic Act.

Records deemed confidential by a manufacturer should be marked to aid FDA in determining whether or not specific information may be disclosed under the Freedom of Information Act. However, routinely stamping every document as "Confidential" defeats the purpose of requesting extra care be taken to protect a specific document or set of documents.

Table 8.2 LOCATION OF DEVICE MASTER RECORDS

Typical Locations of Documents

SOP = Standard Operating Procedure
QSR = Quality System Record
QA = Quality Assurance
QC = Quality Control

Record Retention

The QS regulation in section 820.180(b) requires that all records pertaining to a device shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer. Manufacturers of long­ life products should make prudent decisions as to how long to keep records. For example, there

may be no value in keeping records for long ­life devices such as stretchers, surgical tools, containers, etc., forever if the probability is low that any post ­distribution remedial activity will occur. For devices that require repair or capital equipment devices that probably will be updated, appropriate records should be retained to support these repairs or modifications.

Device master record requirements apply to devices modified in the field by the manufacturer's representatives after the devices are commercially distributed. Modification of a device is manufacturing and the QS regulation covers all manufacturing of devices where the result is placed into commercial distribution. In any case, a manufacturer should be prepared to provide a rationale for its decision to discontinue record-keeping.

DEVICE MASTER RECORD CONTENTS

As discussed above, the device master record shows and/or tells employees how to perform specific functions related to the production of a device. The QS regulation does not dictate how this information is to be arranged or filed in the device master record and quality system record except that it shall be readily accessible. Because each device master record and quality system record contain many documents, an index of each is usually needed.

Device Specification

There may be many specifications in the device master record. One of these is the device specification. A device or product specification is a specific document in the device master record that briefly describes and gives all important details of the external characteristics of a device. The product specification may also contain some internal characteristics of the device that are important to the manufacturer and/or the users. The finished device specification is derived from the design input specifications in 820.30. For some devices, many of the external characteristics such as temperature tolerance are related to the environment in which the devices will function properly. For some in vitro products, the package insert is used by some manufacturers as the product specification for marketing purposes.

Generally a product specification will contain the device's:

• product trade and common name(s);
• intended use(s);
• performance characteristics and theory of operation;
• regulatory classification;
• physical characteristics;
• environmental limitations and product stability;
• important components and formula (if applicable); and
• user safety characteristics.

Table 8.3 contains a list of characteristics that often appear in product specifications; however, note that not all of the listed items will appear in the product specification for a given device.

In addition to defining and describing a device, a product specification is a communication tool which, if used in a timely manner, can help achieve some important results. First, it helps assure that everyone is talking about the same device and working toward the same objectives with respect to safety, effectiveness, human factors, configuration, labeling, packaging, processing, finished device acceptance, etc.

Ultimately, the device specification or a condensed version of it should be used in catalogs, or other product documentation, to aid communication between salespersons and customers. If the marketing department uses the product specifications when preparing advertisements and catalog sheets, public relations with users will be enhanced because the marketing documents are based on proven scientific safety and performance claims for the actual device. The user has an opportunity to read the technical specifications of the item actually being offered for sale.

Thus the use of device product specifications will result in:

• improved communication between employees on a departmental and interdepartmental basis;
• less confusion and increased morale;
• an improved state­ of ­control;
• a higher probability of meeting cost, time, safety, effectiveness, and regulatory compliance objectives; and
• product literature that correctly describes the device for the prospective customer.

A sample product specification for a portable defibrillator is in the exhibits at the end of this chapter. This specification is long and detailed because it is a combined product and test specification, and because it is for a complex device.

Specific Documents

Specific documents are drawings, procedures, labels, data forms, etc., for a specific product or family of products. Product specific documents are almost always part of the device master record. The