niosh compliant product quality plan & quality assurance

Pat

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NIOSH Compliant Product Quality Plan & Quality Assurance Manual Sample

Selected pages (not a complete manual)

Sample includes:

✓ Product Quality Plan Pages

✓ Quality Assurance Manual Pages

✓ Standard Operating Procedure Example

Contact:

First Time Quality

410-451-8006

www.firsttimequality.com

http://www.firsttimequality.com/

[CompanyName]

Product Quality Control Plan

Filtering Face Piece Respirator

[ProductNumber]

Version Date Version notes NIOSH AAR#

[Date] Initial issue [AAR#]

Approval Signature and Date: ___________________________________ _____________________

Quality Manager / Date

Questions? Call First Time Quality 410-451-8006

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[TradeName] – [ProductNumber] Copyright

PRODUCT QUALITY CONTROL PLAN

TABLE OF CONTENTS Background Information .......................................................................................................................... 3

Product Trade and Model Number ............................................................................................................ 3

Product Facility Location ............................................................................................................................ 3

Product description .................................................................................................................................... 3

A. PQP Flowchart ..................................................................................................................................... 4

B. Sampling Plan and Classification of Defects ......................................................................................... 5

Sampling Procedures .................................................................................................................................. 5

Inspection and Test Sampling Plan ............................................................................................................. 6

C. Incoming & In Process Inspection and Test Procedures ........................................................................ 8

D. Final Inspection and Test Procedures ................................................................................................... 9

Final Inspection Test Procedures .............................................................................................................. 10

Required Testing ....................................................................................................................................... 10

E. Simplified Filtering Facepiece Drawing ............................................................................................... 12

F. Assembly Matrix ................................................................................................................................ 14


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A. PQP FLOWCHART PQP flowchart is shown on Figure A-1. The PQP Flowchart shows all inspection and test operations. Each

procedure is identified by AAR# ([AAR#]). Inspection or test procedures (ITP) are clearly identified on the

flow chart. Inspection and Test Procedures are in the Standard Operating Procedures section of the

Quality Assurance Manual.

Figure A-1


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B. SAMPLING PLAN AND CLASSIFICATION OF

DEFECTS Sampling plan and classification of defects document as described in 42 CFR Section 84.41 (c), (d), (e), (f), (g), and (h).

SAMPLING PROCEDURES Samples will be tested based on component characteristics.

The component characteristics are classified according to the potential effect of such defect and grouped

into the following classes:

• Critical. A defect that judgment and experience indicate is likely to result in a condition immediately hazardous to life or health for individuals using or depending upon the respirator.

• Major A. A defect, other than critical, that is likely to result in failure to the degree that the respirator does not provide any respiratory protection, or a defect that reduces protection and is not detectable by the user.

• Major B. A defect, other than Major A or critical, that is likely to result in reduced respiratory protection, and is detectable by the user.

• Minor. A defect that is not likely to materially reduce the usability of the respirator for its intended purpose, or a defect that is a departure from established standards and has little bearing on the effective use or operation of the respirator.

Table B-1 includes a list of characteristics to be tested along with their classification according to the

potential effect of a defect.

Table B-1

Characteristic to be tested Characteristic Classification

Respiratory inlet covering Major B

Filter Unit Major A

Head harness Minor

SAMPLING PROCEDURES AND TIMING OF SAMPLES

A Qualified Inspector will draw random samples from each lot. Each attribute will be tested, and the

results will be recorded. Sampling will be in accordance with [AAR#]-SOP 9.4.1.2 Lot Controlled Samples in

the Standard Operating Procedures section of the Quality Assurance Manual.

Time of Sampling. A sample may be drawn after all units comprising the lot or batch have passed a final

inspection, or sample units may be drawn during final inspection of the lot or batch, in which case the size

of the lot or batch will be determined before any sample units are drawn. If the sample units are drawn

during final inspection of the lot or batch, and if the rejection number is reached before the final

inspection is completed, that sample units already selected shall be rejected.


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C. INCOMING & IN PROCESS INSPECTION AND TEST

PROCEDURES In process inspection and test procedures for items listed on the assembly matrix.

[CompanyName] will perform Incoming and In-process inspections and tests as required under Title 42,

Code of Federal Regulations (CFR) Part 84.

Table C-1 includes a list of In-process inspections and tests. All In-process Inspections and Tests will be

performed in accordance with the [CompanyName] Inspection Test Procedures.

Table C-1

Incoming & In-process Inspection and Test Procedures

Procedure No.

Procedure Standard Test Name

Characteristic to be tested Reference

[AAR#]-ITP-9.3.1.

Purchase Order Material Receiving

Materials used in Production of Filtering Face Piece Units

Inspection and Test 42 C.F.R § 84.41 (a)(4)

[AAR#]-ITP-9.3.3.

Engineering Drawings Assembly Inspection

Filtering Face Piece Complete Unit

Inspection and Test 42 C.F.R § 84.41 (a)(2), (e) 42 C.F.R § 84.61(a)

INCOMING & IN-PROCESS INSPECTION TEST PROCEDURES

In-process Inspection Test Procedures listed on Table C-1 are included in the Standard Operating

Procedures section of the [CompanyName] Quality Assurance Manual.


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[CompanyName] [FacilityAddress]

Quality Assurance Manual

Operating Policies of the

[CompanyName] Quality System

Version Date Version notes NIOSH AAR#

[Date] Initial issue [AAR#]

Approval Signature and Date: ___________________________________ _____________________

President/ Date

Documents provided by [CompanyName] disclose proprietary information as well as copyright information registered with the U.S. Patent and Trademark Office. Please hold these documents in confidence and do not share them with other organizations, even if you do not charge a fee. Submittal of documents does not transfer copyright ownership.


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Quality Manual Copyright

QUALITY ASSURANCE MANUAL

TABLE OF CONTENTS 1. [CompanyName] Quality Management System ................................................................................... 6

1.1. Scope ................................................................................................................................................... 6

1.2. [CompanyName] Quality Policy ........................................................................................................... 6

1.3. Structure of Quality System ................................................................................................................. 6

2. Quality System Management and Responsibilities ............................................................................... 7

2.1. Overview .............................................................................................................................................. 7

2.2. [CompanyName] Quality Policy Responsibilities ................................................................................. 7

2.3. QC Organizational Structure ................................................................................................................ 7

2.4. QC Organization Chart ......................................................................................................................... 7

2.5. Quality Duties, Responsibilities, and Authority ................................................................................... 8

2.6. Quality System Performance Measures ............................................................................................ 10

2.7. Customer Satisfaction Performance Measures ................................................................................. 10

3. Contract Review and Approval ........................................................................................................... 11

3.1. Overview ............................................................................................................................................ 11

3.2. Contract Review and Approval .......................................................................................................... 11

4. Design and Development ................................................................................................................... 13

4.1. Overview ............................................................................................................................................ 13

4.2. Design Input Review .......................................................................................................................... 13

4.3. Product Design Plan ........................................................................................................................... 13

4.4. Design Progress Reviews ................................................................................................................... 14

4.5. Design Output Verification and Approval .......................................................................................... 14

5. Control of Documents and Data ......................................................................................................... 15

5.1. Overview ............................................................................................................................................ 15

5.2. Document Controls ............................................................................................................................ 15

5.3. Document Control Procedure ............................................................................................................ 16

6. Quality in Purchasing ......................................................................................................................... 18

6.1. Overview ............................................................................................................................................ 18

6.2. Qualification of Outside Organizations .............................................................................................. 18

6.3. Periodic Review of Outside Organization’s Qualifications ................................................................ 19

6.4. Control of Purchased Material and Incoming Inspections ................................................................ 19

6.5. Material Receiving ............................................................................................................................. 19

6.6. Material Storage and Release ............................................................................................................ 19

6.7. Purchase Order Terms and Approval ................................................................................................. 20

7. Product Identification and Traceability .............................................................................................. 21

7.1. Overview ............................................................................................................................................ 21

7.2. Lot Control ......................................................................................................................................... 21


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7.3. Lot Traceability and Product Packaging ............................................................................................. 21

7.4. Product Labels and Markings ............................................................................................................ 21

8. Control of Production Processes ........................................................................................................ 23

8.1. Overview ............................................................................................................................................ 23

8.2. Assembly Process Controls ................................................................................................................ 23

8.3. Testing Equipment Controls .............................................................................................................. 23

8.4. Controlled Product Use and Installation ........................................................................................... 23

9. Inspections and Tests ......................................................................................................................... 24

9.1. Overview ............................................................................................................................................ 24

9.2. Incoming Material Inspections and Tests .......................................................................................... 24

9.3. In-Process Assembly Inspections ....................................................................................................... 24

9.4. Final Inspections and Tests ................................................................................................................ 25

10. Control and Calibration of Measuring and Test Equipment .............................................................. 27

10.1. Calibration ....................................................................................................................................... 27

10.2. Verification and Validation of Air-Purifying Testing Machines ........................................................ 27

10.3. Calibration Identification ................................................................................................................. 27

10.4. Calibration Records ......................................................................................................................... 28

11. Inspection and Test Status ............................................................................................................... 29

11.1. Inspection and Test Status of Quality Controlled Materials ............................................................ 29

11.2. Inspection and Test Status of Production Work Tasks .................................................................... 29

11.3. Material and Product Acceptance Status ........................................................................................ 29

12. Control and Correction of Nonconformances ................................................................................... 30

12.1. Overview .......................................................................................................................................... 30

12.2. Handling and Recording of Non-conformances ............................................................................... 30

12.3. Control the Continuation of Work ................................................................................................... 31

12.4. Quality Manager Disposition of Nonconformance Reports ............................................................ 31

12.5. Corrective Actions ........................................................................................................................... 31

13. Preventive Actions ........................................................................................................................... 33

13.1. Overview .......................................................................................................................................... 33

13.2. Identify Preventive Actions for Improvement ................................................................................. 33

13.3. Train Preventive Actions for Improvement ..................................................................................... 33

14. Packaging, Inventory and Handling Controls .................................................................................... 34

14.1. Packaging ......................................................................................................................................... 34

14.2. Inventory and Handling Controls ..................................................................................................... 34

15. Control of Quality Records ............................................................................................................... 35

15.1. Product Quality Control Record Plan ............................................................................................... 35

15.2. Record Controls ............................................................................................................................... 35

16. Internal Quality Audits ..................................................................................................................... 37


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16.1. Overview .......................................................................................................................................... 37

16.2. Internal Quality System Audit .......................................................................................................... 37

17. Training ............................................................................................................................................ 38

17.1. Product Quality Training Assessment .............................................................................................. 38

17.2. Product Quality Training .................................................................................................................. 38

18. Standard Operating Procedures & Forms ......................................................................................... 39

STANDARD OPERATING PROCEDURES AND FORMS

TABLE OF CONTENTS Quality System [AAR#]-SOP 5.2 Document Controls .............................................................................. 41

[CompanyName] System Document Control Form .................................................................................. 43

Quality System [AAR#]-SOP 5.3. Records Controls ................................................................................. 44

[CompanyName] Product Records Control Form ..................................................................................... 45

Quality System [AAR#]-SOP 6.2 Qualification of Outside Organizations ................................................. 46

[CompanyName] Source of Supply List .................................................................................................... 47

[CompanyName] Supplier Qualification Form .......................................................................................... 48

[CompanyName] Laboratory Qualification Form ..................................................................................... 49

[CompanyName] Supplier Certifications and Licenses ............................................................................. 50

Quality System [AAR#]-SOP 7.2 Product Identification and Traceability Procedure ............................... 51

[CompanyName] Daily Production Log .................................................................................................... 52

Quality System [AAR#]-SOP 8.2.1. Assembly Machine Setup Procedure ................................................ 53

Quality System [AAR#]-SOP 8.2.2. Running of Assembly Equipment ...................................................... 54

Machine Process Images .......................................................................................................................... 55

Quality System [AAR#]-ITP 9.3.1 Material Receiving Inspection ............................................................. 56

Purchase Receipt Example ........................................................................................................................ 58

Quality System [AAR#]-ITP 9.3.3 Assembly Inspections ......................................................................... 59

[CompanyName] Assembly Inspection Form ........................................................................................... 60

Quality System [AAR#]-ITP 9.4.1. Final Product/Lot and Earpiece Elasticity Inspection and Test ........... 61

[CompanyName] Final Product/Lot Inspection Form ............................................................................... 63

Quality System [AAR#]-SOP 9.4.1.2. Lot Controlled Samples ................................................................. 64

Quality System [AAR#]-ITP 9.4.2. Final Product/Lot Status .................................................................... 65

Quality System [AAR#]-ITP 9.4.2.1-9.4.2.5 Testing Laboratory Testing Procedures ................................ 67

Quality System [AAR#]-SOP 11.3 Material and Product Acceptance Status ............................................ 68

[CompanyName] Quality Controlled Items List ........................................................................................ 69

Quality System [AAR#]-SOP 12.2.2 Handling and Recording of Lot Unit Nonconformances ................... 70


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[CompanyName] Daily Nonconformance Report Control Log ................................................................. 71

Quality System [AAR#]-SOP 12.2.4 Handling and Recording of Product/Lot Nonconformances ............. 72

Quality System [AAR#]-SOP 12.2.1 Handling and Recording of Material Nonconformances .................. 73

[CompanyName] Nonconformance Report .............................................................................................. 74

Quality System [AAR#]-SOP 16.2 Internal Quality System Audit ............................................................ 75

[CompanyName] Internal Quality System Audit Form ............................................................................. 76

Quality System [AAR#]-SOP 17.2. Product Quality Training Plan ............................................................ 77

[CompanyName] Product Quality Training Plan ....................................................................................... 78

[CompanyName] Product Quality Training Log ........................................................................................ 79


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2. QUALITY SYSTEM MANAGEMENT AND

RESPONSIBILITIES 2.1. OVERVIEW

Responsibilities for quality are specified not only for compliance with policies and procedures but also so

that decisions are based on principles that ensure quality.

Documented responsibilities ensure that expected behaviors are communicated throughout the company

rather than left to discretionary interpretation.

2.2. [COMPANYNAME] QUALITY POLICY RESPONSIBILITIES

Quality is everyone’s responsibility. The President holds everyone in the organization personally

accountable for adhering to the [CompanyName] Quality System policies and procedures.

The [CompanyName] Quality Policy describes the [CompanyName] commitment to quality and reinforces

compliance with the Quality System.

The President communicates the Quality Policy message throughout the company so that all employees

understand their respective quality responsibilities.

The President reviews the [CompanyName] Quality Policy with all employees at least annually.

The President ensures that a copy of the [CompanyName] Quality Policy is distributed to all employees

and is posted in all offices.

2.3. QC ORGANIZATIONAL STRUCTURE

2.3.1. QC ORGANIZATION CHART

The QC Organization Chart shows the QC organizational structure. The organization chart defines lines of

authority between job positions as indicated by solid connection. The lines of authority preserve

independence of quality control personnel from the pressures of production.

Figure 2-1 shows the QC Organization Chart.


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Figure 2-1

When a person with authority is unavailable only a person with higher authority may assume the

responsibility of the unavailable person.

The President assesses the qualification requirements for each position on the QC organization chart,

qualifications of each person, and then appoints only qualified persons to the QC organization.

2.4. QUALITY DUTIES, RESPONSIBILITIES, AND AUTHORITY

2.4.1. PRESIDENT: QUALITY DUTIES, RESPONSIBILITIES, AND AUTHORITY

While everyone is responsible for quality, the President is the one person in the company ultimately

responsible for quality. Regardless of other duties, quality responsibilities of the President include:

• Identify external and internal issues relevant to the purpose and strategic direction of the quality management system.

• Ensuring that each employee understands his or her quality responsibilities as well as [CompanyName] quality policies

• Establishing company quality policies and objectives

• Conducting management reviews of the [CompanyName] Quality System to meet its intended objectives

• Ensuring the availability of necessary resources and information for effective operation of the Quality System

• Demonstrating commitment to the [CompanyName] Quality System and its integrity

• Ensuring achievement of [CompanyName] quality objectives

• Continuously improving the Quality System

• Fully support the Quality Manager in the execution of assigned quality responsibilities

• Ensuring that each design employee understands his or her quality responsibilities as well as [CompanyName] quality policies

• Ensuring that each employee understands his or her quality responsibilities as well as [CompanyName] quality policies

President [PresidentName]

Final/Packaging Quality Inspector

Assembly Quality Inspector

Third Party Testing Laboratories

Operations Manager [OperationsManager

Name]

Quality Managers [QualityManagerNa

me]

Shipping and Receiving Quality

Inspector


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7. PRODUCT IDENTIFICATION AND TRACEABILITY 7.1. OVERVIEW

Product lots are controlled to assure that only lots meeting quality standards, specifications and NIOSH

regulatory requirements receive final acceptance. Controls include material receiving, lot identification,

packaging, and traceability.

7.2. LOT CONTROL

When lot-controlled materials are received, the receiving inspector verifies that the materials have the

specified lot identifications. Lot controlled materials are marked with a Purchase Receipt number that is

traceable to the manufacturer and Purchase Order number.

The Operations Manager maintains lot identification at all production phases from receipt, through

production, assembly, and final completion.

The Operations Manager logs the material Purchase Receipt number on the Daily Production Log in

accordance with Standard Operating Procedure 7.2 Product Identification and Traceability as described in

the Standard Operating Procedures section of this Quality Manual.

At the beginning of each production run, the Operations Manager assigns a Lot # to the lot for which the

controlled material will be used.

At the end of the production run or no later than once per day, the Operations Manager completes the

Daily Production Log with additional Lot information.

The Daily Production Log includes the following information:

- Date - Run Start Number - Run Finish Number - Material Purchase Receipt # - Lot # - Lot Quantity - Inspector’s Signature

7.3. LOT TRACEABILITY AND PRODUCT PACKAGING

Only products with the same lot identification are packaged together.

The Lot number is printed on adhesive labels that will be placed on product packaging. The Lot number

will also be included on invoices and shipping labels.

A database of customer records that include invoice #’s with associated lot identification numbers is

maintained to preserve lot traceability.

If lot-controlled materials are without lot identification, the Operations Manager deems the materials as

nonconforming and segregates them and/or clearly marks them to prevent inadvertent use. The

Operations Manager treats the material according to the company policy for nonconformances. Only the

Quality Manager can re-identify or re-certify the materials.

7.4. PRODUCT LABELS AND MARKINGS


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12. CONTROL AND CORRECTION OF

NONCONFORMANCES 12.1. OVERVIEW

Should a non-conformance be identified by an inspection or test, there is a systematic method to control

the nonconformance, correct it, and ensure that product quality is not adversely impacted by the event.

A non-conforming material is any incoming material(s) that do not meet Purchase Order specifications or

[CompanyName] quality requirements.

A non-conforming product is any product unit(s) that have not received final acceptance from the Testing

Laboratory.

A non-conforming lot is any lot that does not pass testing by the Testing Laboratory.

12.2. HANDLING AND RECORDING OF NON-CONFORMANCES

12.2.1. HANDLING AND RECORDING OF INCOMING MATERIAL RECEIVING NONCONFORMANCES

If non-conforming items exist after the Incoming Material Receiving inspection and cannot be corrected,

the Operations Manager or inspector separates the nonconforming materials by placing them in a

separate area and marks them as nonconforming.

Material Nonconformances are handled and recorded in accordance with [AAR#]-SOP 12.2.1 Handling and

Recording of Material Nonconformances included in the Standard Operating Procedures section of this

Quality Manual.

12.2.2. HANDLING AND RECORDING OF LOT UNIT NONCONFORMANCES

If non-conforming items are found during the In-process Assembly inspection and cannot be corrected,

the Operations Manager or inspector separates the non-conforming units by placing them in a specially

marked container.

The Operations Manager adds the Lot Unit nonconformance(s) to the Daily Nonconformance Report

Control Log and sends it to the Quality Manager at the end of each day.

The Operations Manager handles and records Lot Unit nonconformances in accordance with [AAR#]-SOP

12.2.2 Handling and Recording of Lot Unit Nonconformances included in the Standard Operating

Procedures section of this Quality Manual.

12.2.3. HANDLING AND RECORDING OF PRODUCT LOT NONCONFORMANCES

If the Product Lot is “Rejected” as determined by on-site Final Inspection or off-site testing laboratory

tests, the Operations Manager deems the complete lot unacceptable and moves the lot from its

“pending” location to a specific area for nonconforming, “failed” lots.

The Operations Manager completes a Nonconformance Report and sends it to the Quality Manager.

The Operations Manager handles and records Product Lot nonconformances in accordance with [AAR#]-

SOP 12.2.3 Handling and Recording of Product Lot Nonconformances included in the Standard Operating

Procedures section of this Quality Manual.


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16. INTERNAL QUALITY AUDITS 16.1. OVERVIEW

Audits ensure that the elements of the [CompanyName] Quality System are functioning as intended.

16.2. INTERNAL QUALITY SYSTEM AUDIT

At least annually, the Quality Manager audits the suitability and effectiveness of the [CompanyName]

Quality System.

The audit assesses:

• Alignment of the [CompanyName] Quality Management System with the company quality goals and strategies

• [CompanyName] quality improvement activities

• Product performance evaluations and satisfaction measurement results

• Customer feedback including communications, complaints, and corrective action requests

• Effectiveness of channels of communication

• Effectiveness and conformance to the Product Quality Control Plan

• Quality performance measures

• Supplier performance

• Internal and external Quality Audit results

• Process performance and product conformance results

• Preventive and Corrective Action status

• Follow up on actions from previous Management Reviews

• Other changes (i.e., business climate, scope of work changes, etc.) that could affect the Quality System

The audit assesses the need for improvements including:

• Improvements of the effectiveness of the [CompanyName] Quality System

• Improvements in product quality

• Resource needs

Changes are initiated to improve Quality System performance. The Quality Manager documents Quality

System changes in the [CompanyName] Quality Assurance Manual, initiates needed improvements, and

assesses their effectiveness.

The Quality Manager records the Interna Audit on the Internal Quality System Audit form [AAR#]-SOP

16.2 Internal Quality System Audits included in the Standard Operating Procedures in the Quality Manual.


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18. STANDARD OPERATING PROCEDURES & FORMS

Quality System [AAR#]-SOP 5.2 Document Controls .............................................................................. 41

[CompanyName] System Document Control Form .................................................................................. 43

Quality System [AAR#]-SOP 5.3. Records Controls ................................................................................. 44

[CompanyName] Product Records Control Form ..................................................................................... 45

Quality System [AAR#]-SOP 6.2 Qualification of Outside Organizations ................................................. 46

[CompanyName] Source of Supply List .................................................................................................... 47

[CompanyName] Supplier Qualification Form .......................................................................................... 48

[CompanyName] Laboratory Qualification Form ..................................................................................... 49

[CompanyName] Supplier Certifications and Licenses ............................................................................. 50

Quality System [AAR#]-SOP 7.2 Product Identification and Traceability Procedure ............................... 51

[CompanyName] Daily Production Log .................................................................................................... 52

Quality System [AAR#]-SOP 8.2.1. Assembly Machine Setup Procedure ................................................ 53

Quality System [AAR#]-SOP 8.2.2. Running of Assembly Equipment ...................................................... 54

Machine Process Images .......................................................................................................................... 55

Quality System [AAR#]-ITP 9.3.1 Material Receiving Inspection ............................................................. 56

Purchase Receipt Example ........................................................................................................................ 58

Quality System [AAR#]-ITP 9.3.3 Assembly Inspections ......................................................................... 59

[CompanyName] Assembly Inspection Form ........................................................................................... 60

Quality System [AAR#]-ITP 9.4.1. Final Product/Lot and Earpiece Elasticity Inspection and Test ........... 61

[CompanyName] Final Product/Lot Inspection Form ............................................................................... 63

Quality System [AAR#]-SOP 9.4.1.2. Lot Controlled Samples ................................................................. 64

Quality System [AAR#]-ITP 9.4.2. Final Product/Lot Status .................................................................... 65

Quality System [AAR#]-ITP 9.4.2.1-9.4.2.5 Testing Laboratory Testing Procedures ................................ 67

Quality System [AAR#]-SOP 11.3 Material and Product Acceptance Status ............................................ 68

[CompanyName] Quality Controlled Items List ........................................................................................ 69

Quality System [AAR#]-SOP 12.2.2 Handling and Recording of Lot Unit Nonconformances ................... 70

[CompanyName] Daily Nonconformance Report Control Log ................................................................. 71

Quality System [AAR#]-SOP 12.2.4 Handling and Recording of Product/Lot Nonconformances ............. 72

Quality System [AAR#]-SOP 12.2.1 Handling and Recording of Material Nonconformances .................. 73

[CompanyName] Nonconformance Report .............................................................................................. 74

Quality System [AAR#]-SOP 16.2 Internal Quality System Audit ............................................................ 75

[CompanyName] Internal Quality System Audit Form ............................................................................. 76


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[CompanyName] Quality Manual

Page 40


Quality System [AAR#]-SOP 17.2. Product Quality Training Plan ............................................................ 77

[CompanyName] Product Quality Training Plan ....................................................................................... 78

[CompanyName] Product Quality Training Log ........................................................................................ 79


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QUALITY SYSTEM [AAR#]-SOP 7.2 PRODUCT IDENTIFICATION AND TRACEABILITY PROCEDURE

Version Approved by:

[Date] Quality Manager

Purpose:

To maintain Product Identification and Traceability throughout the receiving, assembly, and shipping

processes.

Scope:

All [ProductName] Lots

Definitions:

None:

Responsible Person(s):

Operations Manager has overall responsibility

Quality Manager

References:

Quality Manual Section 7.0 Product Identification and Traceability

Quality Manual Section 9.3.1 Inspection and Test Records

Quality Manual Section 5.3 Document Control Records

Procedure:

Assembly

1. The Responsible Person will use the Daily Production Log in this procedure.

2. The Responsible Person attains approved lot materials from the material storage area. Only materials marked with a Purchase Receipt Number are approved for use in production.

3. The Responsible Person designates a new Lot number before beginning the production of a Lot.

4. The Responsible Person adds the Purchase Receipt Number of the Lot Controlled Meltblown Filter material, the unique Lot# and the Run Start Number to the Daily Production Log at the beginning of the lot production cycle. Materials for nose pieces and earpieces are not controlled.

5. At the end of the production run, the Responsible Person completes the Daily Production Log with the Date, Finish Number, and Lot Quantity

6. The Responsible Person prints Lot labels with the unique Lot#.

7. The Lot labels are added to the lot packaging.

8. The Responsible Person signs and stores the Daily Production Log in the main office as required by Quality Manual Section 5.3 Document Control Records

.


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[CompanyName] Daily Production Log

Date Start

Number Finish

Number

Material Purchase Receipt Number for Controlled Material

Lot/ Batch #

Lot/Batch Quantity Inspector’s Signature


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For More Information:

Contact: First Time Quality

410‐451‐8006

[email protected]

mailto:[email protected]