4Q1.7-104.pdf

Manual: 4Q1.7 Procedure: 104 Revision: 11

RESPIRATORY EQUIPMENT FACILITY QUALITY

VERIFICATION

Effective Date: 04/18/2016 Type-Class: Admin-Info Page: 1 of 11

1.0 PURPOSE

This procedure provides instructions for Quality Verification of respiratory equipment assembly and testing.

2.0 SCOPE

This procedure applies to the Quality Verification of respiratory protection equipment.

The following OSR form may be utilized in the performance of this procedure:

OSR 4-510, Respiratory Equipment Record and QA

3.0 DEFINITIONS AND ABBREVIATIONS

None

4.0 RESPONSIBILITIES

1. Respiratory Equipment Facility (REF) Lead is responsible for:

Evaluating criteria for acceptance. If significant issues are reported, notifying the Respirator Protection Program Administrator (RPPA) via email.

Determining if issuance of a Nonconformance Report (NCR) is required when significant issues are found, Initiating and responding to NCRs per Manual 1Q, QAP 15-1, Control of Nonconforming Item, Implementing the Switching Rule.

2. REF Personnel are responsible for:

Performing Quality Verification of Respiratory Protection Equipment

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5.0 REQUIREMENTS

5.1 Information

Air-purifying and air-supplied respirators are cleaned and sanitized by an offsite vendor. After cleaning, respirators and cartridges are surveyed for alpha and beta-gamma fixed and transferable radiological contamination. Cleaned respirators and cartridges must meet the following requirements prior to being shipped from the offsite vendor to the REF:

<5000dpm/100cm beta-gamma total fixed contamination and <500dpm/100cm alpha total fixed contamination.

Transferable radioactive contamination <20dpm/100cm alpha and <200dpm/100cm beta-gamma.

5.2 Respirator Facepiece Quality Verification

1. Determine the number of respirator facepieces tested each day on the TSI 8119 Respirator Leak Tester. Those tested each day are considered one lot.

2. Using American National Standards Institute/American Society of Quality (ANSI/ASQ) Z1.4 (Appendices 8.1, 8.2, 8.3 and 8.4), determine the sample size of respirator facepieces to be tested for Quality Verification.

3. Perform the Quality Verification by testing the sample per Manual 4Q1.7, Procedure 215, Operation of TSI Filter Tester 8127 and TSI 8119 Respirator Leak Tester, and recording the quantity on OSR 4-510.

5.3 Air-Supplied Plastic Suit Quality Verification

5.3.1 Jackets

1. Determine the number of jackets assembled and tested each day. Those assembled and tested each day are considered one lot.

2. Using ANSI/ASQ Z1.4 (Appendices 8.1, 8.2, 8.3 and 8.4), determine the sample size of jackets to be inspected and tested for Quality Verification.

3. Perform the Quality Verification by inspecting the following attributes of the sample size and performing testing of the sample as listed in Steps 4 and 5 per Manual 4Q1.7, Procedure 302, Plastic Suit and Welder’s Jacket Assembly, and recording the quantity on OSR 4-510.

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5.3.1 Jackets, (cont.)

4. Quality verification inspection attributes for suits are as follows:

Presence of correct lot number from manufacturer

Overall workmanship – no visible defects

Proper insertion of air distribution system (ADS) through hose guide, collar grommet, and inlet sleeve

Proper clamping of hood clamp

Proper inlet sleeve taping

Hairline cracks on viewing lens of Welder’s suits

5. Quality verification testing attributes for suits are as follows:

As suit inflates, verify no tears, splits or other defects are present to ensure integrity of suit

Verify noise level

5.3.2 Pants

1. Determine the number of pants tested each day. Those tested each day are considered one lot.

2. Using ANSI/ASQ Z1.4 (Appendices 8.1, 8.2, 8.3 and 8.4), determine the sample size of pants to be tested for Quality Verification.

3. Perform the Quality Verification by inspecting the following attributes of the sample size and performing testing of the sample as listed in Steps 4 and 5 per Manual 4Q1.7, Procedure 302, and recording the quantity on OSR 4-510.

4. Quality verification inspection attributes for pants is:

Overall workmanship – no visible defects

5. Quality verification testing attributes for pants is:

As pants inflate, verify no tears, splits or other defects are present to ensure integrity of suit

5.4 Air-Supplied Plastic Hood Quality Verification at the REF

1. Determine the number of air-supplied plastic hoods assembled and tested each day. Those assembled and tested each day are considered one lot.

2. Using ANSI/ASQ Z1.4 (Appendices 8.1, 8.2, 8.3 and 8.4), determine the sample size of air-supplied plastic hoods inspected and tested for Quality Verification.

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5.4 Air-Supplied Plastic Hood Quality Verification at the REF, (cont.)

3. Perform Quality Verification by inspecting the following attributes of the sample size and performing testing of the sample as listed in Steps 4 and 5 per Manual 4Q1.7, Procedure 307, Plastic Hood Assembly, and recording the quantity on OSR 4-510.

4. Quality verification inspection attributes for the air-supplied plastic hoods are as follows:

Presence of correct lot number from manufacturer

Overall workmanship – no visible defects

Proper insertion of breathing air hose through hose guide, collar grommet, and inlet sleeve

Proper clamping of hood clamp

Proper inlet sleeve taping

5. Quality verification testing attributes for the air-supplied plastic hoods are:

As hood inflates, verify no tears, splits or other defects are present to ensure integrity of the hood

Verify noise level

5.5 Single Sampling Plans for Acceptable Quality Limits (AQLs) of 1.0 General Inspection, Level II, with Switching Rules

5.5.1 Acceptance Sampling Information

Acceptance sampling is used for assuring the quality of outgoing goods under this procedure.

The acceptance sampling plan determines the sample size and criteria for accepting or rejecting a batch based on the quality of a sample, using statistical principles. The SRS Quality Assurance Documentation for SRNS Plastic Hoods and Hoses, WSRC-IM-2006-00032 utilizes ANSI/ASQC Z 4.1, 2008, Sampling Procedures and Tables for Inspection by Attributes, for development of the sampling plans and tables in Appendices 8.1, 8.2, and 8.3. The tables define the number of items to inspect based on the lot size and general Inspection level for the commodities being inspected by sampling and the acceptance/rejection levels based on the assigned Acceptable Quality Limits (AQLs).

If the lot size is less than the minimum number to be sampled in the table, inspect 100% of the lot/batch.

When sample does not meet the acceptance criteria, it is often stated that the lot is to be “rejected”. Rejection in an acceptance sampling means to decide that a lot, batch or quantity of product, material, or service has not been shown to satisfy the acceptance criteria based on the information obtained from the sample(s).

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5.5.2 Acceptance Quality Level (AQL)

The AQL is the quality level that is the worst tolerable process average when a continuing series of lots is submitted for acceptance sampling.

The concept of AQL only applies when the acceptance sampling scheme rules for switching between normal, tightened and reduced inspection and discontinuance of sampling inspection is used. These rules are designed to encourage suppliers/workers to have process averages consistently better than the AQL. If suppliers/workers fail to do so, there is a high probability of being switched from normal inspection to tightened inspection where lot acceptance becomes more difficult. Once on tightened inspection, unless corrective action is taken to improve product quality, it is very likely that the rule requiring discontinuance of sampling inspection will be invoked.

The inspection level determines the relation between the lot/batch size and sample size.

General Inspection Levels II, is the general inspection level utilized for this plan.

5.5.3 Lot/Batch

A lot/batch is a collection of items from which a sample will be drawn, for deciding on its conformance to the acceptance inspection. A lot/batch should include items of the same type, size, etc., and that were produced under the same production conditions and time.

5.5.4 Switching Rules

1. Initiation of Inspection

Normal inspection will be used at the start of inspection unless otherwise directed by the Respiratory Protection Program Administrator (RPPA).

2. Continuation of Inspection

Normal, tightened or reduced inspection shall continue unchanged on successive lots or batches except where the switching procedures given below require change.

Implementation of the switching rules will be approved by the RPPA prior to implementation.

3. Normal to Tightened

When normal inspection is in effect, tightened inspection shall be instituted when 2 out of 5 consecutive lots or batches have been non-acceptable on original inspection (i.e., ignoring resubmitted lots or batches for this procedure).

4. Tightened to Normal

When tightened inspection is in effect, normal inspection shall be instituted when 5 consecutive lots or batches have been considered acceptable on original inspection.

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5.5.4 Switching Rules, (cont.)

5. Normal to Reduced

When normal inspection is in effect, reduced inspection shall be instituted providing that all of the following conditions are satisfied.

A. The preceding 10 lots or batches (or more) have been on normal inspection and all have been accepted on original inspection; and

B. The total number of nonconforming units (or nonconformities) in the samples from the preceding 10 lots or batches (or such other number as was used for condition “A” above) is equal to or less than the applicable limit number given in Appendix 8.4. If double or multiple sampling is in use, all samples inspected should be included, not “first” samples only; and

C. Production is at a steady rate; and

D. Reduced inspection is considered desirable by the responsible authority.

5.6 Respiratory Equipment Performance Measures

The REF provides several product lines, all used in the conduct of work activities that pose inhalation hazards to workers. Quality threshold limits have been established for each of these products by considering the average monthly failure rate and monthly variances. If reject levels exceed the quality threshold, then individual modes of failure will be monitored to assist in corrective actions. Individual modes of failure will continue to be monitored until the failure rates fall below the threshold for a period of three consecutive months.

The thresholds are as follows:

Respirator Performance – Quality Threshold Limit 2.5%

Cartridge Performance – Quality Threshold Limit 10%

Hood Performance – Quality Threshold Limit 2%

Suit Jacket Performance – Quality Threshold Limit 4%

Suit Pant Performance – Quality Threshold Limit 4%

Vortex Tube Performance – Quality Threshold Limit 2%

The REF Lead shall track and monitor the monthly performance measures to determine if the failure rates have exceeded the established quality threshold limit. The REF Lead will implement monitoring of individual modes of failure and report monthly results to the REF Manager, Cognizant Quality Function (CQF), and Cognizant Technical Function (CTF) to determine if a nonconformance report is warranted.

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6.0 REFERENCES

10 CFR (Code of Federal Regulations) 851, Worker Safety and Health Program

ANSI/ASQ Z1.4, 2008, Sampling Procedure and Table for Inspection by Attributes

1Q, Quality Assurance, Procedure 15-1, Control of Nonconforming Item

4Q1.7, Procedure 215, Operation of TSI Filter Tester 8127 and TSI 8119 Respirator Leak Tester

4Q1.7, Procedure 302, Plastic Suit and Welder’s Jacket Assembly

4Q1.7, Procedure 307, Plastic Hood Assembly

7.0 RECORDS

Records generated as a result of implementing this procedure are maintained in accordance with Manual 1B, Procedure 3.31, Records Management.

7.1 Forms

OSR 4-510, Respiratory Equipment Record and Quality Assurance Form

8.0 ATTACHMENTS

Appendix 8.1 ANSI/ASQ Z1.4, Inspection Sampling Plan for AQL 1.0 Normal

Appendix 8.2 ANSI/ASQ Z1.4, Inspection Sampling Plan for AQL 1.0 Tightened

Appendix 8.3 ANSI/ASQ Z1.4, Inspection Sampling Plan for AQL 1.0 Reduced

Appendix 8.4 ANSI/ASQ Z1.4, System Switching Rules

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APPENDIX 8.1

ANSI/ASQ Z1.4, Inspection Sampling Plan for AQL 1.0 Normal

This single sampling plan is based on ANSI/ASQ Standard Z1.4-2008. Table I, General Inspection Level II, and Table IIA, Single sampling plans for normal inspection. The AQL is equal to 1.0.

Lot or Batch Size Sample Size Accept Reject

2 to 8 (A) 13 0 1

9 to 15 (B) 13 0 1

16 to 25 (C) 13 0 1

26 to 50 (D) 13 0 1

51 to 90 (E) 13 0 1

91 to 150 (F) 13 0 1

151 to 280 (G) 50 1 2

281 to 500 (H) 50 1 2

501 to 1200 (J) 80 2 3

1201 to 3200 (K) 125 3 4

3201 to 10000 (L) 200 5 6

10001 to 35000 (M) 315 7 8

35001 to 150000 (N) 500 10 11

150001 to 500000 (P) 800 14 15

Over 500000 1250 21 22

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APPENDIX 8.2

ANSI/ASQ Z1.4, Inspection Sampling Plan for AQL 1.0 Tightened

This single sampling plan is based on ANSI/ASQ Standard Z1.4-2008. Table I, General Inspection Level II, and Table IIA, Single sampling plans for tightened inspection. The AQL is equal to 1.0.

Lot or Batch Size Sample Size Accept Reject

2 to 8 (A) 20 0 1

9 to 15 (B) 20 0 1

16 to 25 (C) 20 0 1

26 to 50 (D) 20 0 1

51 to 90 (E) 20 0 1

91 to 150 (F) 20 0 1

151 to 280 (G) 80 1 2

281 to 500 (H) 80 1 2

501 to 1200 (I) 80 1 2

1201 to 3200 (J) 125 2 3

3201 to 10000 (K) 200 3 4

10001 to 35000 (L) 315 5 6

35001 to 150000 (M) 500 8 9

150001 to 500000 (N) 800 12 13

Over 500000 1250 18 19

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APPENDIX 8.3

ANSI/ASQ Z1.4, Inspection Sampling Plan for AQL 1.0 Reduced

This single sampling plan is based on ANSI/ASQ Standard Z1.4-2008. Table I, General Inspection Level II, and Table IIA, Single sampling plans for reduced inspection. The AQL is equal to 1.0.

Lot or Batch Size Sample Size Accept Reject

2 to 8 (A) 5 0 1

9 to 15 (B) 5 0 1

16 to 25 (C) 5 0 1

26 to 50 (D) 5 0 1

51 to 90 (E) 5 0 1

91 to 150 (F) 5 0 1

151 to 280 (G) 20 0 2

281 to 500 (H) 20 0 2

501 to 1200 (I) 32 1 3

1201 to 3200 (J) 50 1 4

3201 to 10000 (K) 80 2 5

10001 to 35000 (L) 125 3 6

35001 to 150000 (M) 200 5 8

150001 to 500000 (N) 315 7 10

Over 500000 500 10 13

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APPENDIX 8.4

ANSI/ASQ Z1.4, System Switching Rules

D is c o n ti n u e

In s p e c ti o n u n d e r

A N

S I/

A S

Q Z

.4

T

IG

H T

E N

E D

S T

A R

T o f o r fe w e r

C o n s e c u ti v e L o ts

N t

A c c e p ta b le

C o n s e c u ti v e L o ts

A c c e p ta b le

C o n s e c u ti v e L

R m a in n

T ig h te n d

P re c e d in g

L

A c c e p te d w it h

T ta l N o n c o n fo rm in g le s t h a n L im it N u m b e r

(o p ti o n a l) a

P ro d u c ti o n s te a d y a p p ro v e d b y

R s p o n s ib le A u th o ri ty

L t n o t

A c c e p te d r

L t

A c c e p te d b u t

N o n c o n fo rm it ie fo u n d b e tw e e n c a d R

E o f P la n o r

P ro d u c ti o n I rr e g u la r, r

O th e r

C o n d it io

W a rr a n t

N O

R M

A L

R E

D U

C E

D

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