RFP 12-14270 SOP-0042 site audit SOP-rev4-DRAFT.pdf

Respirator Certification Program:

Scheduling and Conducting On-Site Compliance Audits

RB-SOP-0042, revision 4 DRAFT October 6, 2011

Rev Date Reason for Change

0 April 30, 1997 CQAB-SOP-0042-00 formally issued and in use.

1 March 18, 2002 Renamed RB-SOP-0042. Name change and reformatted for Word. No content change.

Became draft in use.

2 October 11, 2005 Location changed to Pittsburgh. Major revision which included use of contractors in addition to NPPTL staff. Became draft in use for training and contractor deliverables.

3 March 2, 2006 Changes to document and letter format. No significant change in procedures. Draft in use while formal SOP requirements are being revised

4 October 2011 Major revisions to processes and some terminology. Separated attachments from main document.

Approval Date Signature

1. Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish basic audit principles, criteria and practices, and to provide guidelines for planning, conducting, and documenting quality system audits.

2. Scope: The scope of this SOP is to provide guidelines for verifying the existence and application of a quality system. It also covers verification of the quality system’s ability to achieve defined quality objectives and to meet regulatory standards. This SOP outlines and documents the responsibilities of the NIOSH auditor as both the lead auditor or as a member of a team led by an auditor under contract to NIOSH.

3. Reference Documents:

Title 42, Code of Federal Regulations, Part 84.

ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing.

4. Definitions:

o Auditee: the organization which is the subject of an audit.

o Auditor: a person who has the knowledge and skills to conduct audits; an observer of fact.

o Critical Nonconformance: a nonconformance where there is a danger of injury or loss of life if the nonconformance is not corrected (e.g., no tests on pressure vessels).

o Major Nonconformance: a nonconformance where parts of the quality system are not in place or are not being adhered to. If the nonconformance persists it could result in a critical situation (e.g., not using calibrated measuring devices).

o Minor Nonconformance: a small failure in the quality system (e.g., out-of-date documentation) which is not likely to present immediate health or safety consequences for the users of the product.

o Nonconformance: the non-fulfillment of specified requirements.

o Objective Evidence: qualitative or quantitative information, samples, records or statements of fact pertaining to the quality of an item or service, or to the existence and implementation of a quality system requirement which is based on observation, measurement or test and which can be verified.

o Observation: a statement of fact made as the result of an audit which does not require a corrective action, but which presents an opportunity for a process improvement.

o Quality Audit: a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which a quality system is adequate, functional and effective.

o Quality System: the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

5. Audit Selection: Prior to the start of the fiscal year, the Site Audit Coordinator will select sites to be audited in the upcoming fiscal year. NIOSH will attempt to have audits of respirator production sites occur no more than two years apart. Sites producing self-rescuers will be audited on an annual basis. Locations which do not produce respirators (such as offices where design control or purchasing activities are based) will ordinarily be audited every four years.

Audit locations will be grouped by region to reduce travel expenses and days away from the office.

Audits will be conducted either by NIOSH staff or by contracted auditors. The Site Audit

Coordinator will select whether each audit is to be handled by a NIOSH Lead Auditor or a contracted Lead Auditor. The process for awarding contracts to a specific contractor is outside the scope of this document; once awarded, the contractor, in consultation with the Site Audit

Coordinator, will select an individual to serve as Lead Auditor for each audit.

6. Audit Preparation:

6.1. Once a contract task has been awarded to a contractor, the Site Audit

Coordinator will select a 60-day window for the audit to take place, after consultation with the contractor (if applicable). Approximately 90 days prior to the anticipated audit date, the Audit Initiator will e-mail the pre-audit survey (see Attachment 1) to the approval holder’s primary contact. The Audit Initiator will fill in the primary contact’s name on the pre-audit survey form. The Audit Initiator will state the 60-day window as the desired timeframe and note that the Lead Auditor will follow up later to make detailed arrangements.

6.2. The Audit Initiator obtains a task number from the Records Room for the audit.

Specify:

6.2.1. Manufacturer code

6.2.2. Site code number and city/state/country

6.2.3. Name of Lead Auditor and (if applicable) contract company name

6.3. Once the pre-audit survey is received from the approval holder, the Audit Initiator has the Records Room place it into DEIMS under the assigned TN.

6.4. Audit Initiator looks up contact information for the location to be audited, including:

6.4.1. Site name and street address

6.4.2. Name, e-mail address, and phone number of the primary contact

6.4.3. Name, e-mail address, and phone number of local site contact (if different)

6.4.4. Number of days allocated for the audit

6.4.5. For contracted audits, who from NIOSH will be accompanying (or if none, say so).

For sites producing mining respirators, an MSHA representative may also accompany the audit.

6.5. The Audit Initiator gathers together all the information from 6.4 along with the assigned TNs and information from the pre-audit survey. For NIOSH-led audits, this information is sent to the Lead Auditor individually for each audit. For contracted audits, it is sent to the contractor’s central point of contact as a batch for all audits in a contract task.

6.6. The Lead Auditor will draft an announcement letter (see Attachment 2) and audit plan (see Attachments 3 and 4). A NIOSH Lead Auditor will send it directly to the Audit

Initiator; a contracted Lead Auditor may send it directly, or it may be passed via the contractor’s central point of contact and the Site Audit Coordinator. The Audit Initiator reviews the draft for accuracy. This includes:

6.6.1. Ensure the letter is addressed to the approval holder’s primary contact.

6.6.2. Ensure that a cc: is sent to the approval holder’s/subcontractor’s local contact (if any).

6.6.3. Ensure that a cc: is sent to the auditor.

6.6.4. Ensure that a cc: is sent to the person accompanying from NIOSH (if any).

6.6.5. The auditor will state in the letter which revision of the quality manual is in use.

Check this against the currently-approved revision, and change the letter wording accordingly (is/is not the quality manual of record).

6.6.6. Verify accuracy of the audit plan.

6.6.6.1. Ensure the names, dates, times, quality manual revision, and task number match the letter.

6.6.6.2. Check that the scope is correct (normally there are 14 points; office sites will have fewer).

6.7. Audit Initiator sends the finished letter and audit plan to the Site Audit Coordinator for concurrence.

6.8. Once the letter has been signed and mailed, the Audit Initiator fills in the following fields in DEIMS:

6.8.1. Confirmation letter date

6.8.2. Audit performance date (for multiple days, use last day of audit)

6.8.3. Contract auditor name and company (if applicable)

6.9. The Audit Initiator determines which approvals are produced at the site in question.

6.10. The Audit Initiator looks up the PQPs and assembly matrices for each approval made at the site, and forwards these and the most recent audit report and closing letter for the site to the Lead Auditor.

6.11. In preparation to conduct the site audit, the Lead Auditor shall:

6.11.1. Review previous site audit reports and corrective action taken.

6.11.2. Review any major facility changes that have been communicated to NIOSH, i.e., location, key personnel, equipment, etc.

6.11.3. Review the PQP(s) for respirators produced at the site.

6.11.4. Prepare any checklists required for the audit.

6.11.5. Establish areas of responsibility for the other team members.

6.11.6. Consult the NIOSH staff for information on any current problems with devices manufactured at the audit site.

7. Conducting the Audit:

7.1 The audit team should arrive at the facility 10 to 15 minutes prior to the scheduled opening meeting.

7.2 The lead auditor will conduct a brief opening meeting with the auditee

(approximately 20 minutes). The opening meeting will include:

Introductions of attendees and recording their names/positions

Audit scope and process

Description of methods used to document findings

Confidentiality of audit information

Signing of any required supplemental confidentiality agreements

The three possible outcomes (Acceptable, Provisionally Acceptable, or Not

Acceptable) and the implications of each outcome

Working hours of the site and availability of key personnel

Arrangements for a private working space for the auditors

Arrangements for an audit host and/or guide(s)

Notification of any required safety or evacuation requirements

A provisional time for the closing meeting

A brief facility tour (optional). If this is the first visit to this site for any audit team member, the entire team will commit to a brief tour.

7.3 After the opening meeting (and optional tour) the audit team will then hold a short team meeting. Areas of responsibility will be assigned, if required. After the meeting, the audit shall begin using the basic auditing skills of observing, questioning and listening.

7.4 During the audit, record objective evidence of conformances and non-conformances found in each area. Identify any nonconformance in a clear concise manner. Discuss any potential nonconformances with the auditee to obtain clarification and acceptance of the nonconformance while conducting the audit. Note: If a nonconformance cannot be written in the words of the standard or the procedure being audited, then there is no nonconformance.

7.5 Prior to the closing meeting, conduct a team meeting with the audit team to discuss the audit results.

7.6 The Closing Meeting shall include:

Thanking the manufacturer for their cooperation and hospitality

Recording the names and positions of attendees

Restating the scope of the audit and standards used

Discussing any observations or nonconformances and considering any additional evidence presented

Obtaining acceptance of any nonconformances from the auditee

Explaining the recommended outcome, or clarifying that NIOSH will establish the outcome when they issue the audit report

Communicating the timeframe in which the audit report will be mailed.

Establishing the time frame for corrective actions upon receipt of the

NIOSH audit report:

Not Acceptable - within 15 days of receipt

Provisionally Acceptable - within 30 days of receipt

Closing the meeting

7.7 Any NIOSH employee accompanying a contracted audit shall complete a

Contract Auditor Evaluation form (see Attachment 5) and provide it to the Site

Audit Coordinator.

8. Audit Report: The Lead Auditor shall generate an audit report (see Attachment 6). It shall be delivered to the Site Audit Coordinator within two weeks of the site visit.

8.1. For contracted audits, the report shall be provided in draft form. The contract

Lead Auditor will not select an Audit Result or complete the signature block of the report. The Site Audit Coordinator will assign it to a NIOSH Reviewer to finalize the report and conduct follow-up activities. Ordinarily this will be the NIOSH employee who accompanied the audit (if any).

8.2. For NIOSH-only audits, the NIOSH Lead Auditor will prepare and finalize the report.

This person will serve as NIOSH Reviewer for follow-up activities.

8.3. Finalizing the audit report consists of:

Reviewing the draft report to ensure all nonconformances are supported by evidence and represent a deviation from the audit criteria;

Selecting an Audit Result and corresponding language at the beginning and end of the report;

Completing appropriate contact information in the report body and signature block;

Completing Corrective Action Request forms (see Attachment 7) for each nonconformance; and

Obtaining concurrence from any NIOSH or MSHA personnel present at the site visit.

A NIOSH Reviewer may contact the contracted Lead Auditor for clarification if necessary.

8.4 The Audit Result will be determined using the following criteria:

o Acceptable = no findings.

o Provisionally Acceptable = less than 4 major findings (or the equivalent combination of major and minor findings).

o Not Acceptable = 4 or more major findings or the equivalent combination of major and minor findings. A Not Acceptable rating will also result from the discovery of any critical nonconformance.

Note: Three minor nonconformances equal one major nonconformance. A Not

Acceptable audit will result in consultation between the Site Audit Coordinator and branch management to determine if further action (such as a stop sale request or revocation) is warranted.

8.5 The Site Audit Coordinator shall review the report and, if acceptable, concur on it.

He will then forward it to appropriate branch management for their concurrence and final printing.

9. Corrective Action Follow-up:

9.1. It is the responsibility of the auditee to rectify or correct the cause of a nonconformance within the requested time frame. It is the responsibility of the auditee to communicate these actions to the NIOSH Reviewer within the requested time frame.

9.2. If corrective action(s) are not received in the specified time frame(s), the NIOSH

Reviewer shall bring it to the attention of the Site Audit Coordinator or branch management for further action.

9.3. If corrective action(s) are not effective in resolving the nonconformance, the

NIOSH Reviewer shall continue to follow-up with the auditee. Such correspondence will be normally conducted via e-mail. Bring it to the attention of the Site Audit Coordinator or branch management for further action if the responses are not acceptable. A formal letter should only be used in exceptional circumstances.

9.4 After all corrective actions have been accepted, the NIOSH Reviewer shall prepare an audit closure letter (see Attachment 8) and submit it to the Site Audit

Coordinator for review and concurrence.

9.5 The NIOSH Reviewer shall carry out the necessary internal actions to see that all records are properly filed and recorded in the official NIOSH system of records.

Attachment 1: Pre-Audit Survey

Attachment 2: Audit Announcement Letter

Attachment 3: Audit Plan (one-day audit)

Attachment 4: Audit Plan (two-day audit)

Attachment 5: Contract Auditor Evaluation Form

Attachment 6: Audit Report

Attachment 7: Corrective Action Request Form

Attachment 8: Closing Letter