8.2 Records Are Mandatory Documents


8.2 Records Are Mandatory Documents

Par. 4.2.1(e) of the Standard is very clear about records as mandatory documents. Appendix B of the ISO Guidance on the Documentation Requirements of ISO 9001:2000, provides a list of such records (see Table 8.2.) Notice that the required records are given in a descriptive manner, and it is up to the organization to clearly define which specific records are to be kept. Typical records of this type are indicated in Table 8.2.

Table 8.2: Records Required by the Standard with Typical Actual Records Maintained

Clause

Mandatory Record

Typical Records

5.6.1

Management Reviews

Minutes of the monthly review

Weekly departmental reviews

In-house publications

6.2.2(e)

Education, training, skills, and experience

Resumes

Certificates of course work (internal/external)

External studies/seminars

Individual employee training record

Signed off training attendance sheets

Annual reviews

Syllabus for training session

On-the-job (OJT) training records

Training schedules and plans

7.1(d)

Evidence that the realization processes and resulting product fulfill requirements

Nonconforming material reports (NCMRs)

Returned material authorizations (RMAs/RGAs)

Repair history sheets

Routers/travelers

Supplier certificates of analysis (C of Cs/C of As)

Inspection and test stamps

Waivers/concession reports

Customer release reports

Shelf-life records

ESD records

Shipping records

Customer site reports

Warranty records

7.2.2

Results of the review of requirements relating to the product and actions arising from the review

Requests for quotes, proposals

Catalog quotes

Purchase orders

Sales orders

Sales acknowledgments

7.3.2

Design and development inputs

Market analysis

Regulatory standards

Requirements document

Competitive product analysis

Research and development results

7.3.3

Design and development output—not explicitly called out as requiring records; these are "implied" records

Software functional specification

Hardware functional specification

User's manual

Risk and hazard analysis

Systems specification

Verification and validation test protocols

Bill of materials

7.3.4

Results of design and development reviews and any necessary actions

Design review minutes

Final drawings

Final schematics

Final systems specification

Transfer to production plan

7.3.5

Results of design and development verification and any necessary actions

Test data packages

Alpha testing results

Final design modifications

Verification and validation of software completed

Summary verification test report

Controlled laboratory notebooks verified

7.3.6

Results of design and development validation and any necessary actions

Test data packages

Beta testing results

Customer validation reports

Summary validation test report

7.3.7

Results of design and development changes and any necessary actions

Engineering change orders

Engineering change requests

Revised drawings and prints

Transfer to production sign off

7.4.1

Results of supplier evaluations and actions arising from the evaluations

Approved supplier list

Evaluation of supplier performance

Supplier corrective action reports

Certificates of compliance/analysis

Source inspection reports

Incoming receiving reports

Surveys of suppliers

Supplier audit reports

7.5.2(d)

As required by the organization to demonstrate the validation of processes, where the resulting output cannot be verified by subsequent monitoring or measurement

Computer validation report

Customer numeric control (CNC) validation report

Employee qualification report

Process validation report

Machine validation report

Revalidation reports

Employee requalification reports

7.5.3

The unique identification of the product, where trace-ability is a requirement

Serial number logs

Control of stamps logs

Receiving logs

Inspection reports

Testing reports

Heat numbers

Certificates of compliance/analysis

Pick lists

Packing lists

7.5.4

Customer property that is lost, damaged, or otherwise found to be unsuitable for use

Nonconformance material reports

Nonconformance product reports

Returned material authorizations

Returned goods authorization

Product repair reports

7.6(a)

Standards used for calibration or verification of measuring equipment where no international or national measuring standards exist

In-house designed test fixtures

Software verification and validation reports

Ad hoc industrial Standards

In-house designed measuring fixtures

Golden electronic boards

7.6

Validity of previous results when measuring equipment is found not to conform with its requirements

Corrective action reports

Nonconforming product reports

Recall reports

Returned goods authorizations

7.6

Results of calibration and verification of measuring equipment

Test hardware validation

Test software validation

Inspection equipment calibration

Measuring equipment calibration

Test equipment calibration

Master calibration lists

8.2.2

Internal audit results

Audit schedules with assignments

Audit plans and checklists

Audit reports

Vendor/supplier audit reports

Third-party audit reports

Customer audit reports

8.2.4

Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product

Receiving inspection and test reports

In-process inspection and test reports

Final inspection and test reports

Vendor/supplier certificates of compliance/analysis

Your certificates of compliance

Declaration of conformity

Pass/fail records

Quality-control stamps

Quality-assurance release records

Device history records

8.3

Nature of the product nonconformities and any subsequent actions taken, including concessions obtained

Rework records

Scrap records

Nonconformance tags

Hold tags

Customer release records

Waiver records

Concession reports

8.5.2

Results of corrective action

Corrective action reports (CARs)

Supplier corrective action reports (SCARs)

Audit corrective action reports (ACARs)

Registrar's nonconformance reports (NCRs)

Summary presentation at the management review

8.5.3

Results of preventive action

Preventive action reports (PARs)

Root-cause analysis reports

Action team reports

Summary presentation at the management review

This area tends to be one of mass confusion due to a lack of specificity [1]. Records (used as objective evidence of activities) complement the hierarchal documents and can be associated with any tier. For example, records do not require a separate documentation control numbering system because they are already controlled, either centrally or locally, by date and signature.

Imagine how confusing it would be to take a form with a control number F-103-01, fill it in, and then give it another control number R-103-01 for storage as a record. This is a danger in ISO document control interpretation and is certainly not specified in the Standard.

Another case of confusion can occur when forms are signed off to approve their distribution. In that case, it really gets confusing between the form's approval signature and the signature of the operator who signs off in the data columns. Approval sign-offs on forms should be avoided and are usually removed once the issue is discussed.

8.2.1 Records As Historical Documents

A record is basically an historical document that contains information that is worth keeping for some time. The most familiar form of record keeping is the documents we maintain for the Internal Revenue Service. For an FDA-regulated organization, the need to maintain device history records is made painfully clear via U.S. government penalties [2]. Records are usually filled-in forms, but they can be in the form of memoranda, reports, or e-mails.

8.2.2 Records As Objective Evidence

The Standard's vocabulary requires that a record should contain useful information that either lists achieved results or provides evidence that some operational activity was performed. This set of requirements provides the framework for an expansive list of specific records (see Table 8.2).

To create a meaningful set of records requires that we do not use just the category sales and marketing records, but that we define sales and marketing records explicitly (e.g., quotations, purchase orders, sales orders, acknowledgments, purchase order changes). We also specify where they are kept (e.g., maintained in the sales files cabinet). Further, we specify who maintains the records (e.g., maintenance of the records is by the sales and marketing administrative supervisor). In addition, we specify retention time (e.g., all records are kept for the current year plus 2 years). Finally, we specify who can destroy records (e.g., records cannot be destroyed without the direct approval of the controller). It is usually best to avoid specifying the exact nature of record disposal and state that it is at the discretion of top management (e.g., the controller).

[1]The subject has received some deserved dedicated attention. See, for example, Brumm, Eugenia K., "Managing Records for ISO 9000 Compliance," Quality Progress, January 1995, p. 73. The book of the same title is also available from the ASQ, ISBN 0-87389-312-3.

[2]Quality System Regulation, Part VII, Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 820, Current Good Manufacturing Practices (CGMP): Final Rule, October 7, 1996, published by the SAM Group, Stat-A-Matrix, Edison, N.J., Sec. 820.181: Device Master Record.




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

flylib.com © 2008-2017.
If you may any questions please contact us: flylib@qtcs.net