Other documents that are referenced such as GUM,. ISO/IEC 17025, USA Code
of Federal Regulations. (CFR), etc. ▫ Document Control system may be a paper,
...
A 17025:2005 Management System Made Simple What to think about when reviewing the Management System
Structure of the Standard & HB 150 ¾
Non-linear ¾ Requirements are not mutually exclusive
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Holistic ¾ This is a complete system, not just pieces and parts ¾ Section 4 works with Section 5 and vice versa
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NVLAP Requirements: Section 3, Annex A, Annex B, Annex C and Annex D
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Organization ¾
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Organizational Chart ¾ Communication pathways ¾ Defines who is the lab and who is outside the lab Who’s in Charge? ¾ Top Management: Who is top management and what role does top management play? Technical Manager/Quality Manager ¾ Does the Technical Manager need to understand Quality? ¾ Does the Quality Manager need to have Technical expertise? 3
Management System ¾
Ownership ¾ It’s the lab’s system and should speak to what the lab
DOES and HOW it DOES it
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The tail shouldn’t be wagging the dog ¾ Reflect and support technical activities ¾ Dynamic (aka: LIVING) system ¾ Nothing is carved in stone but… ¾ It should be a pretty solid system
Holistic System ¾ To understand it, Read it, Speak it, Step back ¾
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Management System ¾
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Top down ¾ Management buy-in and commitment: Understanding the metrology/testing mission Bottom up ¾ Staff commitment from metrologists/technicians to admins to shipping clerks Integrity of the Management System during change ¾ Management shall lead the effort, audit (monitor) it, and make sure that the outcome meets the needs
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Defined Document Structure ¾
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Structure of Management System Documents must make sense to those who use it. Simple, Transparent: Document type titles should reflect their function Remember that the management system documents are a valuable training tool Bottom line: Do the management system documents meet the REQUIREMENTS of the standard, of the AB? (Read the book!) 6
Document Control ¾ ¾ ¾
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Defined document structure – Master List Revisions, Version, Issue ¾ Terms, Styles should be consistent! Page Numbers ¾ X of Y ¾ End of Section ¾ End of Document ¾ How does this work with electronic systems? Pointers to supporting documents ¾ Standard Operating Procedures, Standard Administrative Procedures, Work Instructions… 7
What are Documents?
NIST Handbook 150 Management System Documents
Includes equipment manuals, test/calibration methods
All standards listed or referenced on the scope of accreditation Other documents that are referenced such as GUM, ISO/IEC 17025, USA Code of Federal Regulations (CFR), etc. Document Control system may be a paper, electronic, or hybrid. 8
Document Changes Write-protection in electronic documents ¾ Handwritten Changes – Allowed? Reissue expediency (Integrity) ¾ Electronic changes – how indicated ¾ Review process and sign-off ¾ History of revisions ¾ Archival documents ¾
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Document Control ¾
References ¾ References are part of the management system:
How are they controlled? What is the Policy & Procedure? ¾ Make sure list is current (internal audit & management review) ¾ Historical documents clearly indicated ¾ Is it historical OR is it required by regulation or contract?
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Requests/Tenders/Contracts Incoming work: Communication ¾ Who receives, who reviews, who approves, who schedules? ¾ What happens if something goes awry? ¾
¾ Personnel, equipment issues (turnaround time)
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Records
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Subcontracting
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Subcontracting occurs when: ¾
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Tests/measurements/calibrations that are on the scope of accreditation cannot be performed by the lab and are sent to a competent subcontractor Some requested tests/measurements/calibrations do not appear on the scope and are sent to a competent subcontractor. Client is informed and agrees.
Subcontracted results are clearly identified on the certificate/report Subcontracting may not be the basis of demonstrating competency during an assessment (i.e. what is on the scope must be demonstrated by the lab --- not the subcontractor) 12
Subcontracting ¾
List of approved subcontractors ¾ HOW were they approved? ¾ Who, what, when and accreditation status
Records of customer notification and approval ¾ If subcontracting is not done, the QM should state so clearly ¾ Does the P.O. to the subcontractor state that the work to be performed is accredited work (if applicable)? ¾
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Purchasing supplies and services ¾
Policy/Procedure for services and supplies that affect the quality of tests and/or calibrations ¾ Metrological Traceability
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Inspection/evaluation/verification prior to use ¾ Fit for purpose ¾ Comply with applicable/specified requirements ¾ Appropriate level to support calibrations/tests
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Purchasing supplies and services ¾
Purchasing documents ¾ ¾
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Description of supply/service Technical review/approval record
Evaluation of suppliers ¾
Accreditation status ¾ ¾ ¾
Scope Uncertainties (see Annex B) MRA Partners or
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Record of supplier audit (B.2.4)
Verify accreditation status and scope 15
Seeking Customer Feedback ¾
Actively sought ¾ Surveys after the service ¾ Paper ¾ Web-based
Positive and Negative ¾ Analyze feedback ¾ Management review ¾
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Complaints ¾ ¾
Policy and Procedure Who is complaining? ¾ ¾ ¾ ¾ ¾
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Customer AB Management Technical Staff Regulator
Records of all complaints received, investigation of and corrective actions taken. Corrective /preventive actions with root cause analysis (first) 17
Control of nonconforming work ¾
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Policy/procedure ¾ Who is responsible for ¾ Initiating work ¾ Halting work ¾ Notifying customers if necessary ¾ Recalling work ¾ Resuming work Initiate corrective action to prevent recurrence Evaluate impact Maintain records 18
Corrective action ¾
Policy ¾ Appropriate authorities ¾ Sources of identification
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Procedure ¾ In the beginning:
A cause analysis
¾ Why did it happen? ¾ Don’t just treat symptoms
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Preventive Action Identify needed improvements and potential sources of nonconformities ¾ Nonconformities can be technical or within laboratory’s management system ¾ Complaint records source for ideas – look for connection ¾
Preventive Action is Proactive 20
Corrective/Preventive Action ¾
Laboratory must develop procedures for preventive actions ¾ Include initiation of preventive actions ¾ Also include application of controls to ensure
actions are effective – do nonconformaties recur?
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Control of Records ¾
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Quality records: Internal audits, management reviews, corrective actions, preventive actions, complaints Technical records: ¾ ¾
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Record at time made, linked to task Corrections: still see original, change must be signed ¾
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Sufficient information to repeat calibration/test Identify factors that affect uncertainty
Equivalent for electronic records
Question: What is an original observation? 22
IMPROVEMENT ¾
Continual vs. Continuous
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The danger of status quo
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Is the concept of continual improvement woven into the entire system – what’s the evidence?
Continuous Improvement
Continual Improvement
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Internal Audits ¾
Performed periodically ◄DEFINED ¾
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Whole system or broken into segments (technical part of calibration or test methods must be included) Trained/qualified personnel ¾ ¾
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How trained? External Vendor or In-house How qualified? What evidence exists
Laboratory must have written records of audits Audits carried out by a customer or assessments by NVLAP SHALL NOT be considered an internal audit
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Management Reviews Pre-determined, documented schedule and inputs ¾ Involves Top Management reviewing ¾
¾Continuing suitability of management system and
Calibration activities ¾Used to introduce: ¾Changes ¾Improvements
¾Used for planning ¾Goals ¾Objectives ¾Action plans
Management Reviews Conducted separately from internal audits ¾ Documentation (agendas/reports) of reviews – addresses the ‘laundry’ list ¾ Beware the paper exercise – Look for METRICS ¾
¾ How is success being evaluated?
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Personnel ¾
Challenge of Succession planning ¾ Training, Training, Training
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Documentation of Qualifications ¾ Continual training ¾ Cross-training ¾ Review
Effectiveness of training ¾ Goals for further training (succession planning…) ¾
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Environment Documented appropriate environmental conditions ¾ Monitor/record ¾
¾ Metrological traceability of environmental monitors
Stop work/resume work: Who is responsible? ¾ Cleanliness ¾ Access ¾
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Test & Calibration Methods ¾
Selection of methods ¾ Needs of the customer ¾ Appropriate
International, national, regional ¾ Lab-developed ¾ Up-to-date instructions ¾ Inform the customer ¾
¾ Records 29
Method Validation Control charts ¾ Analysis of measurement that substantiate uncertainty claims ¾
¾ analysis of resultant data ¾ comparison to other methods ¾ interlaboratory comparisons ¾ Use of a NIST-calibrated artifact
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Appropriate range and accuracy of values obtained 30
Uncertainty Completeness of uncertainty budget ¾ Source of component values (e.g. own measurement, manufacturer) ¾ Method and validation of uncertainty values ¾
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Data Control ¾
Policy/Procedures to verify data transfer ¾ Systematic
Data Integrity (cross-check analysis) ¾ Spreadsheets – ¾
¾ Are the cells really locked? ¾ Who validated the calculations?
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Verify calculations
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Equipment ¾ ¾ ¾ ¾ ¾ ¾ ¾ ¾
Equipment list (including associated control software and/or instrument firmware) Proper identification Location Instructions/manuals Calibration or certification status and intervals Validation Intermediate checks Safeguard against adjustments 33
Measurement Traceability Documented path of measurements and uncertainties ¾ Ref: NIST HB 150 Annex B ¾
Detailed information in Presentation on Metrological Traceability
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Reference Materials ¾
Program and Procedure for calibration of Reference standards ¾ Only used for calibration to ensure integrity of value
Metrological traceability to the SI where possible ¾ Intermediate checks to maintain confidence in values ¾ Transport and storage ¾
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Sampling Representative sample of the whole ¾ Plan and procedures for sampling ¾
¾ Available where the sampling is taking place ¾ Based on appropriate statistical methods
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Records ¾ relevant data ¾ procedure ¾ identification of the sampler ¾ Other pertinent information (environment, location,
etc.) 36
Handling of Test and Calibration Items Provisions to protect the integrity of test or calibration item and interests of the customer ¾ System for identifying and tracking the test or calibration item ¾ Examination upon receipt to assess the condition of the item and suitability for test or calibration ¾ Appropriate facilities to avoid deterioration or loss during storage, handling, and preparation ¾
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Assuring Quality of Results Statistical process control ¾ Check standards ¾ Proficiency tests ¾ Redundant measurements ¾ Correlation plots ¾
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Reporting Results Accurate ¾ Clear ¾ Unambiguous ¾ Objective ¾ In accordance with any specific instructions in the test or calibration method ¾
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Reports and Certificates ¾ ¾
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Title Name & Address of lab where tests/calibrations performed Unique ID of report Name & Address of Customer ID of method used Unique ID of item tested/calibrated Date of Receipt where critical to results
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Date of test or calibration Reference to procedures, sampling plans used Test or Calibration results with units of measurement Name, function and signature or other ID of person(s) issuing report Statement that results relate only to tested/calibrated items where relevant.
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Reports: Additional Information Where Appropriate/Needed ¾
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Deviations from, additions to, exclusions from test method Specific test conditions Statement of compliance/non-compliance Statement of estimated uncertainty of measurement Opinions and interpretations
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Date of Sampling Unambiguous ID of Substance/Material/Product Location of sampling (Diagrams, photographs, sketches) Sampling plan and procedure used Environmental details when they affect results
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