Improvement Opportunities for Audit Reporting

Report
Registration Management Committee
Improvement Opportunities
for Audit Reporting
Tony Marino and Rick Downs
July 19-20, 2012
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Company Confidential
Registration Management Committee
Workshop Approach:
• Review form instructions
• Break up into teams and review report
• Each team will present its critique of the
report reviewed
• As a group we will reach a consensus on
what improvements are needed
• We will review a QMS Matrix, NCR and PEAR
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
QMS Process Matrix Report:
• For each site audited, the QMS Process Matrix shall be
completed to identify which processes and quality management
system clauses have been audited.
• NOTE 1: This form can also be used to document the audit program
for a full certification cycle and the audit plans for each audit (e.g.,
stage 2, surveillance, recertification).
• NOTE 2: The standard is structured as indicated in the left hand
vertical column; the organization identifies their
processes and provides the listing to the audit team leader.
These processes shall be listed at the top of the form. The audit
team with the organization’s assistance identifies the
interrelationships between the standard’s clauses and
organization’s processes (e.g., organization has a design process
and clause 7.3 is associated to this process). In some cases, the
organization’s process may have the same name as the clause of
the standard (e.g., Purchasing).
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
QMS Process Matrix Report:
Identify the organization’s processes, subprocesses, and value added activities, as defined by the
• 8
audited organization. Identify the name of the associated
area(s) involved, if appropriate.
• NOTE 1: For a site, it is possible that not all organization processes
are applicable and/or performed at this location. In this situation,
list the applicable processes or activities within a specific process
performed at this site/location.
• Examples of processes/sub-processes/value added activities:
– Product Realization:
»
»
»
»
»
»
»
Manufacturing – Machining
Manufacturing – Painting
Manufacturing – Assembly
Purchasing
Design
o Design/Avionics Dept.
o Design/Door Actuators Dept.
• NOTE 2: If there are more processes than columns, additional
forms can be used.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
QMS Process Matrix Report:
• 9 Identify
in box 8.
the PEAR ID
as completed for the process indicated
• NOTE: At a minimum, for each audited product realization
process a PEAR must be completed.
• 10 For each process, indicate the applicable 9100/9110/9120
clause(s) as follows:
– Record a ”C” to denote a clause found Conforming.
– Record a ”N” to denote a clause found Nonconforming.
• NOTE: For clauses not applicable or not evaluated the appropriate
box remains empty.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
QMS Process Matrix Report:
• In your teams review the QMS Process Matrix Report
provided. Come to a consensus and record any concerns
and recommended improvements on your flip chart.
• If consensus cannot be reached record the differing
thoughts on your flip chart.
• Select a team spokesperson.
• You have 10 minutes.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
Nonconformity Report (NCR):
• 7 The NCR has four sections; each section shall be
completed in order, at the various stages of the NCR:
– Section 1 – documented by the auditor when recording the
nonconformity.
– Section 2 – documented by the auditee after the containment
action, root cause analysis determination, and corrective action
plans are defined; and the implementation of the corrective
action by the auditee has occurred.
– Section 3 – documented by the auditor after verification of
the implementation and effectiveness of the corrective action
by the auditor.
– Section 4 – documented by the auditor and audit team
leader after final acceptance/closure of the NCR.
• NOTE: The audit team leader and auditee can agree on
multiple stages for status reporting of the NCR for Section 2
(e.g., after correction, after planning the corrective action,
after completion of the corrective action).
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
Nonconformity Report (NCR):
• 9 Identify the primary 9100/9110/9120 clause(s) and/or
customer requirement to which the nonconformity was
written.
• 10 Determine the nonconformity classification (i.e., major,
minor) according to the definitions provided in this
standard (see clauses 3.2 and 3.3 of this standard). When
the nature of the nonconformity needs immediate
containment action, the auditee shall describe the
immediate actions (‘fix now’) taken to contain the
nonconforming situation/conditions and to control any
identified nonconforming products. Correction shall always
be recorded.
• NOTE: Any immediate containment action and correction
can be reviewed by the audit team during the audit.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
Nonconformity Report (NCR):
• 19 Provide a detailed description of the root cause(s) of
the nonconformity; that is describe how/why the
nonconformity occurred.
• NOTE: In most cases, documenting ‘isolated case’ or
‘lack of instruction’ are not appropriate ‘root causes’
as there are system causes in other domains (e.g.,
insufficient supporting or management processes).
• 21 Describe the action(s) to be taken to prevent the
recurrence of the nonconformity.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
Nonconformity Report (NCR):
• In your teams review the NCR provided. Come to a
consensus and record any concerns and recommended
improvements on your flip chart.
• If consensus cannot be reached record the differing
thoughts on your flip chart.
• Select a team spokesperson.
• You have 15 minutes.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
Process Effectiveness Assessment Report (PEAR)
• 8 Identify the process assessed; indicate the name of the
process, as defined by the organization.
• 9 Summarize the process activities, inputs, and
outputs; including the identification of associated
process interfaces.
• 10 Identify the applicable primary 9100/9110/9120
clause(s) for this process.
• 11 Describe the method used by the organization to
determine process effectiveness [e.g., identification of
Key Performance Indicators (KPIs) and associated
targets, process capability data].
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
Process Effectiveness Assessment Report (PEAR)
• 12 Annotate relevant objective evidence, observed
conditions, data, information, comments, etc. to support
the auditor's statement of effectiveness or
ineffectiveness, as indicated in Box #13.
• 13 Indicate to what extent the audited process was
determined effective.
• Effectiveness: extent to which planned activities are
realized and planned results achieved (reference ISO
9000).
– NOTE 1: A major (ma) NCR shall be issued when the
effectiveness level of the process is rated a "1".
– NOTE 2: A major (ma) or minor (mi) NCR shall be issued when
the effectiveness level of the process is rated a "2" (see
nonconformity definitions in clause 3).
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
Process Effectiveness Assessment Report (PEAR)
• In your teams review the PEAR provided. Come to a
consensus and record any concerns and recommended
improvements on your flip chart.
• If consensus cannot be reached record the differing
thoughts on your flip chart.
• Select a team spokesperson.
• You have 15 minutes.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
Wrap Up
• Effective completion of new 9101 forms relies on:
– Effective communication – Be brief and succinct
– Instruction sheets are there to help
– We are dealing with both compliance and performance
» Effectiveness is not subjective, a process is either
implemented (compliant) or not and either targets
are met or not
– Corrective Actions must address all root causes
identified
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
Questions
RMC Workshop Minneapolis, MN 19 – 20 July 2012

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