Quality manual

Quality System Manual QP-820.5

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1. Quality Policy

LLC as an importer/relabeler of quality medical device shall ensure that quality are

met from conception, design, build, test to post-market to achieve customer

satisfaction, prompt problem resolution, employee loyalty and continuous quality

improvements which are communicated to all its suppliers and contract manufacturers

who are partners in providing quality products.

2. Quality System

Management details its quality system in this Quality Manual to support the quality

policy on a daily basis and to meet the Quality System Regulations appropriate for ’s

medical device. Management shall review the Quality System on a regular basis and

assure that it is effective with the following management responsibility [Subpart B of

Quality System Regulation]:

• Establish and maintain Quality System

• Assure audits

• Staff up and train

LLC shall comply with good manufacturing practice while ensuring supplier quality

requirements are also met and all customer complaints have been addressed and

necessary corrective and preventive actions were established and monitored for

continuous quality improvement. Specifically, the following standards will be

adhered to with corresponding standard operating procedures:

• Sec. 820.100 Corrective and preventive action Procedure and Form

• Sec. 820.50d Purchasing Procedure

• Sec 820.5.6 Management Review

• Sec 820.90 Complaint Handling Procedure and Form

• Sec 820.100b Medical Device Reporting Form and Procedure

• Sec 820.40 Document Control Procedure

• Sec 820.80 Receiving Procedure

• Sec 820.50c Supplier Quality Agreement and Audit Report/Checklist,

Evaluation Procedure and Vendor List

• Sec 820.170 Service/Install Report Form and Procedure

• Sec 820.100b Returned Parts Authorization

• Sec 820.160 Shipping Procedure

• Sec 820.NN Training Procedure

• Sec 820.22 Quality System Audit Procedure and Form

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3. Management Responsibility: as an Importer

LLC as an importer/relabeler of a medical device in the USA shall:

• Register establishment

• Report serious adverse events to FDA, report MDRs to manufacturer

and report to FDA on corrections and removals

• Implement tracking procedures for specified devices

• Distributor must keep records of complaints and make records

available to the FDA

• Dealers and distributors in some cases must hold such information as

is necessary to identify and locate first purchasers

• Establish good manufacturing practice as defined in Quality Manual

and Supplier Quality Requirements documents

4. Process Validation

shall use its Post-Market Surveillance to obtain general retrospective product

validation through the review and summary report of performance, CAPA and

product failure analyses. During installation and testing at , validation tests are run

per Validation Test Procedure. shall review production and testing data as needed

by its test engineers.

5. Personnel and Training

shall have defined roles and responsibilities for each employee with documented

training and updated training as required by their job function. All the required skills

and responsibilities should be defined by their supervisors and a performance

evaluation should be done once per year with both employee and supervisor rating

their performance. All training in-house and outside training (online, seminars,

readings) should be documented in each employee file. All new hired employee

should attend a 1-hr Quality System Regulation training.

6. Management Review

Management shall conduct periodic reviews to maintain Quality Management System

using the Management Review Procedure SOP 820.5.6.

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7. Supplier/Contract Manufacturer Quality Requirements

(Design Control, Equipment and Calibration, Process and

Document Control, Labeling, DMR, Packaging,

Purchasing and Acceptance Activities, Risk Analysis from

Design to test)

suppliers or contract manufacturers should have established their quality system

based on the sections of the QS regulation as applicable to their products and

operations, 21 CFR 820.5 of the QS regulation. It is the responsibility of each

manufacturer to establish requirements for the medical device that is imported by

that will result in devices that are safe and effective, and to establish methods and

procedures to design, produce, distribute, etc. devices that meet the quality system

requirements.

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The following supplier requirements are reviewed and audited by management on

a regular basis:

1. Supplier quality requirement to comply with Subpart C – Design Controls of

Quality System Regulation. Management (both and Contract Manufacturer

executive management) must assure:

- that a documented process exists for design development which meets the

requirements.

- that the design teams have the necessary training/skills to implement the design

process effectively.

Management to audit procedures for design control comprising of the design plan

and processess with focus on customer requirements and user interfaces and risk

analysis.

Management to audit design input requirements, design output specifications and

design transfer to production documents (DHF, DHR, DMR).

Management to audit processes necessary to move between each phase:

- V&V

- Hazard/risk analysis

- design reviews

- change control

2. Supplier quality requirement to comply with Subpart D – Document Controls of

Quality System Regulation. Management to audit documentation system to

support QS requirements and assure prompt communication of adequate

procedures. Management to review on a regular basis procedures with defined

approvals and track changes.

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3. Supplier quality requirement to comply with Subpart E – Purchasing Controls of

Quality System Regulation. Management must assure an appropriate mix of

assessment controls to assure that the product received is what was specified in

the product order process.

4. Supplier quality requirement to comply with Subpart F – Identification and

Traceability of Quality System Regulation. Management must assure

identification procedure to prevent mix-ups and to assure traceability if deemed a

“critical device”. Management must be able to get “bad” product back.

Management must review the following to prevent mix-ups: procedures for

identifying product and traceability requirements for critical devices and recalls

during all stages of receipt, production, distribution and installation

5. Supplier quality requirement to comply with Subpart G – Production and Process

Control of Quality System Regulation. Management must assure that production

processes are controlled and monitored. Management must audit the

development, conduct, control and monitoring of production processes:

- control changes and verify or validate when necessary

- environmental conditions, where necessary

- personnel practices

-contamination control

- buildings to prevent mix-ups

- equipment and necessary preventive maintenance including periodic inspections

- manufacturing material

- calibrations, standards, limits and records

- automated processes and validation of software and equipment

- process validation and records

- monitoring and control of processes

- revalidation

6. Supplier quality requirement to comply with Subpart H – Acceptance Activities

of Quality System Regulation. Management must assure that only “good”

components go into product and only “good” product gets released to customers.

Management to review in an audit established and maintained procedures:

- receiving acceptance activities

- in-process acceptance activities

- final acceptance activities

- acceptance records

- acceptance status

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7. Supplier quality requirement to comply with Subpart I – Nonconforming Product

of Quality System Regulation.

Management must review nonconforming material and take the necessary steps to

correct and prevent the problem from occurring.

Management shall audit procedures to control nonconforming product:

- components, in-process and final product

- review and disposition

- rework

8. Supplier quality requirement to comply with Subpart J– Corrective and Preventive

Action of Quality System Regulation.

Management must assure that the workforce has an understanding of root cause

analysis and that the appropriate techniques are used to correct and prevent

quality problems. Management must assure that quality problems are investigated.

Management shall audit procedures for:

- analyzing

- investigating

- identifying the action

- implementing and recording changes

- disseminate to those responsible

- submit relevant info on identified quality problems

- correlate corrective and preventive actions to risk

9. Supplier quality requirement to comply with Subpart K – Labeling and Packaging

Control of Quality System Regulation. Management must assure that the product

is labeled and packaged correctly to assure that the customers receive the product

with the intended specifications.

Management to review the procedures to control labeling activities:

- labeling integrity

- labeling inspection

- labeling storage

- labeling operations

Management to review control numbers for traceability where necessary

Management to review procedures to control packaging:

- protect device

- for handling product

- for control of storage areas and stock rooms

- for receipt and dispatch

10. Supplier quality requirement to comply with Subpart L – Handling, Storage,

Distribution and Installation of Quality System Regulation.

Management must assure that the handling, storage, distribution and installation is

controlled.

Management must audit procedures for control and distribution, review customer

purchase orders before distribution via a contract review requirement, review

distribution records and review installation instructions and procedures

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11. Supplier quality requirement to comply with Subpart M – Records of Quality

System Regulation. Management must assure that the record requirements for

this QS Regulation are met and enforced.

Management must met the general requirements for record retention of two years

with the exceptions of management reviews, internal audits and supplier audits.

Management must audit DMR, DHR, DHF and QSR.

Management must review complaint files:

- review and evaluate all complaints

- investigate “possible” failure

- MDRs

- Investigations

12. Supplier quality requirement to comply with Subpart N – Servicing of Quality

System Regulation. Management must assure that product is serviced properly

and documented to meet requirements.

Management must review instructions and procedures, 4.19 Servicing, and

analyze service reports.

13. Supplier quality requirement to comply with Subpart O – Statistical Techniques

of Quality System Regulation.

Management must assure that the statistical tools are appropriate for the operation

or process being monitored.

Management must review procedures, 4.20 Statistical Technique, for identifying

valid statistical techniques for establishing, controlling and verifying the

acceptability of process capability and product characteristics and review

sampling plans procedures and control.

_____ defines its supplier quality requirements in the Supplier Quality Requirements

document. Quality Director shall perform quarterly quality audit to ensure that supplier

quality requirements are met. For all non-conformance needing immediate actions,

effective communication and documentations are followed by both Quality Director and

the supplier Quality management. See Complaint Handling and CAPA sections of this

Quality Manual for issues regarding non-conformance, deficiencies or quality

improvements. Quality Director shall ensure that the supplier or contract manufacturer

has established its Risk Analysis process based on the following standards:

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8. Shipping, Receiving and Installations

shall follow the following procedures:

• Shipping Procedure to control shipping information per customer

• Receiving and Inspection Report procedure when receiving incoming materials

and to ensure that these materials are properly dispositioned after evaluation and

inspection.

Accounting and Quality Assurance departments shall have a copy of inspection

records.

9. Complaints Handling

shall follow its Complaints Handling procedure for all non-conformance and

deficiencies related to the product, process or quality. It is the responsibility of

Complaint Handling Coordinator to communicate to management, FDA and the

supplier or manufacturer all related complaints from all sources and monitor

corrective actions from the supplier/contract manufacturer to field service.

Complaint Handling Procedure is based on the 21 CFR 820.198 Complaint Files

regulatory standard. All complaints (including reportable events, MDRs) are logged

using the Complaints Handling form. Each complaint and its corresponding

supporting documents or investigations should be stored in a separate folder. A

summary of all complaints are stored in Excel spreadsheet for easy monitoring.

Another form for MDR , reportable events, shall be created in addition to the

Complaints Handling form and a duplicate folder should be created for each MDRs.

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10. Corrective Action and Preventive Action

shall follow its Corrective Action and Preventive Action (CAPA) procedure for all

CAPA-related complaints related to the product, process or quality. It is the

responsibility of Complaint Handling Coordinator to communicate to management,

FDA and the supplier or manufacturer all related complaints from all sources such as

quality audit or other management approved CAPAs.

Reference: Sec. 820.100 Corrective and preventive action.

(a) Each manufacturer shall establish and maintain procedures for implementing

corrective and preventive action. The procedures shall include requirements for:

(1) Analyzing processes, work operations, concessions, quality audit reports, quality

records, service records, complaints, returned product, and other sources of quality

data to identify existing and potential causes of nonconforming product, or other

quality problems. Appropriate statistical methodology shall be employed where

necessary to detect recurring quality problems;

(2) Investigating the cause of nonconformities relating to product, processes, and the

quality system;

(3) Identifying the action(s) needed to correct and prevent recurrence of

nonconforming product and other quality problems;

(4) Verifying or validating the corrective and preventive action to ensure that such

action is effective and does not adversely affect the finished device;

(5) Implementing and recording changes in methods and procedures needed to correct

and prevent identified quality problems;

(6) Ensuring that information related to quality problems or nonconforming product is

disseminated to those directly responsible for assuring the quality of such product or

the prevention of such problems; and

(7) Submitting relevant information on identified quality problems, as well as

corrective and preventive actions, for management review.

(b) All activities required under this section, and their results, shall be documented.

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11. Quality System Audit

_____ shall perform internal quality system audit per SOP-820.22/FRM-820.22 and

supplier/contract manufacturer quality requirements audit per FRM-820-50c once a

year. A summary report of the quality audit shall be communicated to both and its

supplier/contract manufacturer. These audit findings can be a source of CAPA and

can be used as feedback mechanism for customers, and its suppliers for continuous

quality improvement and to provide proactive measures for all its operations and the

operations of its suppliers. Quality metrics will be tracked regularly by both and its

suppliers.

12. Revision History and Approval

Revision Date Name Change

00 6/7/2010 Connie Dello Buono Initial release

Approved by: President____________________ Date ___________

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Quality manual

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