Document Type: QMS Corporate Branch - Plant

Manual: Quality Management Title: Compliance of Records Originator:

No: QMS-220

Rev: -

Notice: GeneLink Bioscience, Inc. Confidential Information

Page 1 (Review and Approval)

REVIEWED BY:

_ __________________
Quality Manager

Date

_ _________________
Operations Manager

Date

APPROVED BY:
_ Director of Operations
Approval Date 04-14-12 Effective Date

Date

Rev Original issue

Nature of Change

Document Type: QMS Corporate Branch-Plant

Manual: Quality Management Title: Compliance of Records Process Owner:

Notice: GeneLink Bioscience, Inc. Confidential Information

No: QMS-220001

Rev: -

Page 2 of 4

1.0

PURPOSE 1.1 This procedure was develop to identify, store, protect, retrieve, retain and disposition of quality management system records within the plant. These records are used to demonstrate evidence of conformity to the current requirements of dietary supplements and the effectiveness of the quality management system in production manufacturing.

2.0

SCOPE 2.1 This procedure applies to the management and control of any quality records within the scope of quality guidelines. Any records pertaining to plant quality operations are to be controlled and labeled adequately with full compliance but only accessible with express permission of management.

2.2

3.0

REFERENCES 3.1 None.

4.0

DEFINITIONS 4.1 Record(s): A document that provides objective evidence of any activities performed or results achieved in plant operations. A record can be written or stored on any data medium. Branch Quality Manager: Individual, regardless of job title, with the responsibility for administering the plant standard operating procedures (SOP). Data Records: Any data supporting a process being made in plant operations, obtained through observation, measurement, lab testing, R & D or other means.

4.2

4.3

5.0

RESPONSIBILITY 5.1 Plant quality operations are responsible for developing and maintaining procedures relating to the control of records. The plant Quality Manager is responsible for maintaining records for the plant or remote locations if applicable, media type and retention requirement of records. Plant management are fully responsible for ensuring that any records contained in their areas of responsibility are legible, identifiable, retrievable, stored or archived in an appropriate environment to prevent damage, and retained for at least the defined period of time available as required. Employees assigned direct responsibility for the handling of records are accountable for complying with the requirements of this procedure.

5.2

5.3

5.4

Document Type: QMS Corporate Branch-Plant

Manual: Quality Management Title: Compliance of Records Process Owner:

Notice: GeneLink Bioscience, Inc. Confidential Information

No: QMS-220001

Rev: -

Page 3 of 4

5.5

Employees are also responsible for reporting record damages or loss to plant quality managers. In addition, managers are responsible for taking corrective action as appropriate to prevent further damage or loss.

6.0

PROCEDURE/WORK INSTRUCTION 6.1 Identification 6.1.1 Hard copy of data records produced internally are identified with either a form number, a unique title or both. Hard copy reports can be pictures or work instructions, where significant to plant operation. Electronic records produced internally are identified either by title, subject line or description in the procedures or work instructions that document the process of their generation or use were appropriate. If presented with a record of external origin, plant operations management reports the existence of the record to the quality manager. The quality manager assigns a unique identifier if needed, assesses the appropriate media format and attaches identification to the record. The data record must be controlled and retained as required by plant quality operations. This information is entered onto the controlled external documents log, if applicable. External records that are not already uniquely labeled are assigned a unique control number by quality manager. For hard copy documents, this number is recorded on the front and back cover. For electronic documents, the number is attached to the record as deemed most practical by the consensus of plant quality management.

6.1.2

6.1.3

6.1.4

6.2

The location and retention requirements for internal records are listed on the records master list maintained by plant quality management. Storage and Retrievability 6.3.1 Plant operations process records, where records are retained, they are filed in such a way that they are easily identifiable and retrievable. The storage of records is listed on the records master list. If a record should travel to remote locations, its final storage location is listed.

6.3

6.3.2

6.4

Protection 6.4.1 Plant quality operations can store quality records in such a way that they are readily retrievable and in a suitable environment to prevent damage or loss. To verify the effectiveness of plant quality document and preservation efforts, the legibility and retrievability of records is assessed by internal quality audits.

Document Type: QMS Corporate Branch-Plant

Manual: Quality Management Title: Compliance of Records Process Owner:

Notice: GeneLink Bioscience, Inc. Confidential Information

No: QMS-220001

Rev: -

Page 4 of 4

6.4.2

Employees are instructed to report any damage or loss of records to plant quality management. Plant quality operations can take corrective action as appropriate to prevent further damage or loss and report the incident to quality manager. Changes to electronic records are noted within the content of the record when possible and/or tracked by the internal document revision.

6.4.3

6.5

Retention and Disposition 6.5.1 Plant quality management can dispose of records that exceed the retention minimum (as shown on the Records Master List) on a yearly basis. In deciding on the timing and method of disposal after the retention period, plant quality operations assess the availability of appropriate storage space, business security exposure risks. Plant records that contain sensitive or proprietary information are disposed of by shredding or other confidential material disposal technique.

6.6

Retention Guidelines - Minimum retention periods are assigned using the following guidelines: 6.6.1 6.6.2 6.6.3 6.6.4 6.6.5 Electronic records Five years Quality performance records (inspection and test results) Five year Internal Quality Audits and Management Review Five years Nonconforming material records one year Corrective Action and Preventive Action Five years

7.0

RECORDS 7.1 The following records result from this procedure: Controlled internal or external documents list to records master list

8.0

ATTACHMENTS (EXHIBITS, FLOWCHARTS, ETC.) 8.1 None.