实验室审核标准

Document Name:
Global Outside Lab Qualification
Procedure
Date Revised:
21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden.
Appendix to GES-0128:
Outside Lab Capability Assessment
REQUIREMENTS
REPORT FORM
COMMENTS CARD
COPYRIGHT © 2008 WHIRLPOOL CORPORATION
Document Name:
Global Outside Lab Qualification
Procedure
Date Revised:
21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden. TABLE OF CONTENTS
Page Foreword ....................................................................................................................................... 11 Auditee Preparation Guidelines ...................................................................................................... 11-12
Suggested Outside Lab Capability Assessment Agenda ................................................................. 13 Outside Lab Capability Assessment Topics .................................................................................... 13 Requirement Statements and Guidelines ........................................................................................ 14-15 Auditee Final Assessment Status ................................................................................................... 16 Outside Lab Capability Assessment Requirements ......................................................................... 17 L1 - Quality Systems (equipment & data integrity)................................................................. 18 L2 - Materials Testing .......................................................................................................... 19 L3 - Codes & Regulatory Requirements ............................................................................... 20 L4 - Test Specifications & Procedures .................................................................................. 21 L5 - Test Plans .................................................................................................................... 22-23 L6 - Reliability ………………………………………………………………
24 L7 - Lab Product Approval Process ...................................................................................... 25-26
L8 – Lab Personnel Experience ………………………………….…………..
27-28 L9 – Product Experience and Market Experience (29)
Glossary of Terms …………………………………………………...
30-31 Outside Lab Assessment Report .................................................................................................... 33 Assessment Individual Key Scores and Findings ............................................................................ 33-35 Comments Card ............................................................................................................................ 36 Comments & Suggestions ..............................................................................................................
37
Document Name:
Global Outside Lab Qualification
Procedure
Date Revised:
21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden.
FOREWORD
The purpose of this document is to define the proper standard for the assessment of outside labs for potential data source(s) to support Whirlpool Corporation ’s product approval process. It is expected that any outside lab providing data will do so in a manner consistent with Whirlpool ’s Product Approval and Lab Operation process; thus, this Whirlpool ’s assessment is based upon the same “18 PALO Keys to Lab Improvement ” as is used internally at Whirlpool.
This Outside Lab Assessment is to be used under the direction of a trained Product Approval representative.
The contents of this document explain the necessary steps involved when going through a Whirlpool Outside Lab Assessment. The first section in this package is the “Outside Lab Audit Assessment Guidelines,” which are recommendations on how and what to prepare for the official assessment. Following that is the “Suggested Assessment Agenda .” This agenda is supplied to help the outside lab understand approximately how the time is allocated throughout the day while conducting the assessment. It is only a suggested agenda and does not take into account the size or complexity of the location being
assessed. The section “Guidelines for Use ” contains information about how to use this document. The biggest and most important section called “Assessment Requirements,” lists all the assessment requirements that will be used to evaluate the Outside Lab ’s Capabilities. This section is the core of the assessment process and the assessment team will evaluate the outside lab based upon this material. The sections have been organized to allow a natural flow or progression of questions while performing the Outside Lab Assessment. Finally, the last section called “Outside Lab Assessment Results &
Comments Card ,” is a copy of the forms used to write the final assessment report. It includes a copy of a survey that may be filled out by the outside lab after the assessment is complete. It is through this feedback that we can continue to make the assessment process more valuable.
This document shall provide all the necessary information to complete an Outside Lab Assessment and Final Report. If any more information is required, the outside lab shall contact the lead assessor. This person can answer any remaining questions.
It is our intent that this process will provide Global Whirlpool Technology and Procurement personnel with a solid
understanding of each Outside Lab ’s capabilities such that enlightened decisions can be made regarding potential testing outsourcing.
AUDITEE PREPARATION GUIDELINES
AUDITEE: This checklist is provided as an aid to help prepare you for your upcoming Outside Lab Capability Assessment . Basically, a Whirlpool team will be assessing your lab capabilities relative to specific Whirlpool needs and requirements. The key to a successful and efficient audit is preparation, both on the part of the auditee and the audit team. Your responsibility, as Auditee, is to make sure that the following items have been addressed and available as needed.
A. Has the agenda for the day(s) of the audit been established and communicated? This is the responsibility of
Whirlpool Lead Assessor. If not complete, please contact the Lead Assessor.
Document Name:
Global Outside Lab Qualification
Procedure
Date Revised:
21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden.
B. Have you reviewed the Outside Lab assessment standard, understand the requirements and used them to
perform a self-evaluation prior to the official visit? Have you sent a copy of your self-assessment to the Whirlpool Lead assessor? C. Do you understand the scoring system?
D. Is your documentation and supporting evidence readily available? Suppliers should prepare for the assessment
by gathering initial documentation & evidence by key, summarize it, organize it in a manner that the information can be rapidly selected for discussion, and prepare for additional background evidence should the Lead Assessor desire additional material.
Key Point: The audit can be conducted in a much more efficient manner if the supporting documentation is
arranged in a sequence corresponding to the Whirlpool requirements.
The audit documentation can be flowcharted according to your design process. You may arrange the evidence in that order and notify the lead auditor of the desired flow and the lead auditor will follow your recommendations by re-arranging the assessment keys in the order you have recommended (note: all keys must be completed).
E. Have you identified the key contact person (Lab Manager or equivalent) to represent your organization and
interface with the lab assessment team? F. Do you have lead people identified for specific sections of the audit (i.e. reliability, equipment calibration,
personnel experience, document management, planning, etc.)? Are they “ready ” when called upon? G. Has a conference room been reserved for the audit team to use? H. Is a telephone available? I.
Given the expected complexity of the audit and the size of the facility, has the overall time duration of the audit been estimated and consideration given to necessary breaks, including lunch arrangements, if needed? (Note: In the interest of time, a quick working lunch brought to the audit location is typically preferred.)
J. Is any safety equipment required (i.e. safety glasses, steel toe shoes, hearing protection, etc.)?
Finally, if you have any other questions or concerns they can and should be resolved with the Whirlpool Certified Lead Assessor prior to the actual audit day.
Document Name:
Global Outside Lab Qualification
Procedure
Date Revised:
21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden.
SUGGESTED ASSESSMENT AGENDA
ACTIVITIES:
EST. DURATION
Introduction (Team members/Auditee representatives) .................................................................. 10 - 20 min. Auditee overview of Lab Operation & Facilities .............................................................................. 30 min. Lab Facility Tour ........................................................................................................................... 30 min - 1 Hr. Lab Capability Assessment ............................................................................................................ 4 - 6 Hrs. Scoring & Report Development (Whirlpool Team Only) ................................................................... 30 min – 1 Hr. Closure Meeting ............................................................................................................................ 30 - 45 min.
Note: This suggested agenda does not take into account the size or complexity of the location being assessed. The estimated duration should be seen as a guideline only. A typical assessment can take anywhere from 5.0 hr. to 9.0 hrs .
Outside Lab Capability Assessment Topics
Key No.
KEY NAME
L1 QUALITY SYSTEMS (equipment & data integrity) L2 MATERIALS TESTING
L3 CODES & REGULATORY REQUIREMENTS L4 TEST SPECIFICATIONS & PROCEDURES L5 TEST PLANS L6 RELIABILITY
L7 LAB PRODUCT APPROVAL PROCESS L8 LAB PERSONNAL EXPERIENCE
L9
PRODUCT EXPERIENCE AND MARKET EXPERIENCE
Document Name:
Global Outside Lab Qualification
Procedure
Date Revised:
21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden.
REQUIREMENT STATEMENTS AND GUIDELINES
As mentioned in the Foreword, this audit was designed to evaluate all three dimensions of a lab ’s capability; the Personnel , Equipment, and Documentation . To achieve this, each assessment page is laid out in the following manner: The “KEY ” statements are the first statements written in “Bold ” letters on top of every page in the assessment. The key
Document Name:
Global Outside Lab Qualification
Procedure
Date Revised:
21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden.
Key Scoring
As indicated above, all keys have as a scoring technique a series of incremental points. Within each point are a number of ‘criteria statements ’ that correlate directly with increased compliance to the requirements of the key. From point-to-point these criteria build upon each other in a progressive manner toward excellence in the “Key ” subject matter.
For the purposes of scoring, to achieve the “point being evaluated ” the auditee must, in the opinion of the Lead Assessor , meet or exceed all of the criteria based statements assigned to it . Only after meeting the current ‘point ’ requirements may the assessor look toward the next level of incremental criteria. Also, as noted above, to aid in scoring decisions, half-point scores (0.5, 1.5, or 2.5) are permissible.
If all of the criteria are not met, the score shall be recorded at the previous “point ” level or, as appropriate, at the half-point score between the previous score and the next incremental score. Key Scoring
POINTS
CRITERIA
0 Non-Existent – System requirements have not been addressed; there is essentially no evidence of implementation or compliance.
1 Traditional - System requirements may informally exist but they are unstructured and potentially inefficient. There is minimal compliance toward required standards.
2 Learning - Adequate awareness and understanding of the preferred approach with basic proficiency and implementation levels, reasonable documentation.
3 Leading – Full awareness and understanding of the preferred approach with effective and efficient implementation levels, solid documentation, an operational model.
Lead Assessor Questions
The Lead Assessor Questions shown with each key are intended only as “thought provokers ” or “response generators ”. Their sole purpose is to stimulate supplier discussion on the key topic in a manner applicable to the key ’s scoring criteria. They are not meant to be “all inclusive ”; thus a supplier should focus their attention on the scoring criteria and not the lead assessor questions.
Overlap of Key Content
From time-to-time it is fully expected that the content of various “Keys ” will overlap with the content of similar keys. To a degree, this is planned into the assessment. The repetition of seeing a topic in multiple areas of this assessment simply signifies the importance of its content.
While this may spark some discussion regarding fairness of scoring if the auditee has a particular weakness in the duplicated area; it needs to be recognized as well that if the auditee has strength in this area, their strength will be likewise be multiplied throughout the assessment.
Document Name:
Global Outside Lab Qualification
Procedure
Date Revised:
21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden.
None, No, Some, Occasional, Most, Majority, All and Always in Criteria Statements:
Many of the Results Oriented criteria statements are specifically designed to probe the level of results that the design system should create. There are four levels of evaluation for these questions that contain results oriented requirements. These four levels can be recognized by the use of the words “None, Some, Most and All ” (and their synonyms) in the evaluation criteria. The meaning of these words can be reasonably quantified as shown in the following table:
LEVEL RANGE None, no 0 – 5 % Some, occasional 6 - 50 % Most, majority 51 - 85 % All, always
86 - 100 %
Multiple Outside Lab Operations
If an Outside Lab has multiple lab operations (i.e. an automotive lab, an appliance lab, a lab for all others, etc.) for the purpose of managing development, cost, and efficiency, the Whirlpool Outside Lab Assessment shall be applied to the section of the Outside Lab ’s business that would typically be utilized to test Whirlpool parts and product.
ASSESSMENT STATUS
Auditee Status:
In addition to the assessment scores, auditees are classified under one of the four different status choices. This status is with regard only to the capability assessment. Additional reviews of specific facility, equipment, fixtures, and test procedure reviews are necessary for final determination of qualification level. These four status choices are Full Qualification , Conditional Qualification, Qualification in Process, and No Qualification . See matrix below:
Assessment Status
Criteria
(assumes all Keys are being assessed)
Full Qualification Assessment that has a minimum score of 2 points or more for each key.
Conditional Qualification Assessment that has less than a minimum score of 2 points for any key, but has documented an improvement plan that is acceptable to Whirlpool, with regard to quality and schedule.
Qualification In
Process
Assessment that is not complete, but plans are in place.
No Qualification
No plans or desire to qualify currently.
Document Name:
Global Outside Lab Qualification
Procedure
Date Revised:
21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden.
OUTSIDE LAB
ASSESSMENT
REQUIREMENTS
Document Name:
Global Outside Lab Qualification
Procedure
Date Revised:
21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden.
KEY #L1 - QUALITY SYSTEM (EQUIPMENT & DATA INTEGRITY)
Description: This ‘Key ’ is designed to understand the process for maintaining integrity of their test equipment, test and equipment procedures (work instructions), and test records. Lead Assessor Questions:
1. What is your process to calibrate & update laboratory test equipment?
2. What is your process for updating test / equipment procedures or work instructions?
3. What is your document control process for test records?
4. What independent lab certifications or accreditations do you currently hold? (ie. ISO-17025, UL, etc.) 0 pts There is no evidence of test equipment calibration
No evidence of a process to maintain control of test procedures (work instructions) and
test records.
1 pt
Some evidence of acceptable test equipment calibration; some examples of expired
calibration tags
An informal process to maintain control of test data & documentation exists (procedures,
work instructions, etc.).
Some test procedures are out-of-date or do not match actual practice
2 pts
Most equipment has acceptable calibration and measurement systems analysis evidence
available
A formal process to maintain control of test data & documentation exists (procedures,
work instructions, etc.).
Most test procedures are up-of-date and match actual practice
There exists evidence that key test procedures are reviewed periodically
3 pts
The lab is currently ISO-17025 accredited OR meets the following requirements:
All equipment has acceptable calibration and measurement systems analysis
evidence available
All test data (records) is stored in an easily accessible location, controlled through a
formal document control system, and are kept for set periods of time (e.g. records retention)
All test procedures are up-of-date and match actual practice
All test procedures are reviewed per schedule or process trigger (evidence required) Equipment is calibrated based upon MSE / MSA needs or control charting
Notes
* - calibrated
based upon factual, demonstrated evidence that ‘control ’ has been lost in the measurement device as opposed to calibration based upon a selected time interval.
Document Name: Global Outside Lab Qualification
Procedure
Date Revised: 21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden.
KEY #L2 – MATERIALS TESTING
Description: The Auditee may be expected to have a fully equipped materials testing lab to analyze and test materials for proper formulation and material properties analysis during design and development. Expected scope would be materials applicable to the industry of the products being tested.
Lead Assessor Questions:
1. What material testing capability do you have at this location?
2. Do you have all the material testing equipment needed for your products?
3. Do you have plans to update the materials testing lab? 0 pts There are no materials testing capabilities at this location
All materials are contracted out for testing and/or analysis
1 pts
Some material testing is completed at this location
The more difficult material testing is contracted out
Most auditee test personnel have less than (2) years of test experience
Most materials testing is done based upon informal, unapproved procedures
2 pts Most materials testing is completed at this location
Most material testing is completed with formal, detailed test procedures and analysis
reports.
Most test result records are archived for future reference
Some auditee test personnel have greater than (5) years of test experience
Some test personnel have (2) or more years of formal college training
3 pts All material testing is completed with formal, detailed test procedures and analysis
reports.
All test result records are archived for future reference
All test result records are archived and easily retrieved for future reference
Some auditee test personnel have greater than (10) years of test experience
Most test personnel are degreed engineers
Notes
Document Name: Global Outside Lab Qualification
Procedure
Date Revised: 21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden.
KEY #L3 – CODES & REGULATORY REQUIREMENTS
Description: This ‘Key ’ is intended to understand how codes and regulatory requirements are implemented and validated at the auditee ’s facility. It also is intended to assess the competency of personnel associated with the codes and regulatory operations.
Lead Assessor Questions:
1. Please describe the methods used in your product development group to ensure adherence to regulatory agency codes
and product safety requirements.
2. Please describe your level of certification (of lab and technicians) by appropriate codes agencies (e.g. UL, CSA, IEC,
etc.).
0 pts No identified codes function at this design location
No codes agency certification of lab and/or technicians Auditee expects all codes & regulatory requirements to be their customer ’s responsibility 1 pt
Some engineering change notice approvals include a sign-off from a codes/safety standpoint There is some evidence that outside codes houses are leveraged to minimize the risk that regulatory gaps may exist 2 pts
Some codes engineer(s) are in place at auditees design facility Some codes agency certification of auditees lab and/or technicians – or - some evidence that outside codes houses are leveraged Most engineering change notices are reviewed and signed-off by a codes/safety expert Most codes requirements are completed by product release Most code engineer test requirements are fully documented 3 pts
Lead codes engineer has more than 5 years experience in the Product Approval and Lab Operations All engineering change notices AND temporary change authorizations have a codes/safety sign-off All appropriate labs and technicians are certified by regional appropriate codes agency All codes requirements are completed by product release All code engineer test requirements are fully documented Notes
Document Name: Global Outside Lab Qualification
Procedure Date Revised: 21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden.
KEY #L4 - TEST SPECIFICATIONS & PROCEDURES
Description: Test specifications and procedures are the backbone of the testing and validation process. Their accuracy and use drive the verification and fitness for use decisions that must be made for new and revised products. This key investigates the auditee ’s test specification management system.
Lead Assessor Questions:
1.
What is your process to develop and update test specifications? 1.
Is there linkage of test specifications to customer needs? 2.
How is data from the field used to create or improve specifications? 3.
Who reviews newly created specifications prior to formal release? What is their authority? 4.
How are specifications / test procedures reviewed over time? 5. What independent lab certifications or accreditations do you currently hold? (ie. ISO-17025, UL, etc.)
0 pts
There is no process to develop or update test specifications 1 pt There is limited input from design, customer, and field test results into test specification
creation
Test specifications are informally written by individuals who individually put them to use
Procedures / test specifications are informally reviewed
2 pts A formal process exists for the development and updating of test specifications; however, it
may not always be used as individually generated test specifications still occasionally exist
There is some input from ‘the customer ’ and ‘field test results ’ into test specification
development
There is some collaboration between design and the lab organizations in test specification
creation
Released procedures / test specifications are formally reviewed to ensure correctness;
review schedule is variable
3 pts The lab is currently ISO-17025 accredited OR meets the following requirements:
A formal, approved process for the development and updating of specifications exists
and its use is a business requirement.
Most specifications are developed based upon customer intended functions and are tied
to customer needs / benefits with historical data from the field
A great deal of collaboration exists between design and lab organizations in test
specification creation
Released procedures / test specifications are regularly reviewed by a cross-functional
technical team according to a developed schedule
Notes
Document Name: Global Outside Lab Qualification
Procedure
Date Revised: 21-May-08
© 20yy – 20yy Whirlpool Corporation. The subject matter shown hereon is disclosed in confidence to the extent it is original with Whirlpool.
Disclosure to other parties except in filling Whirlpool orders is forbidden.
KEY #L5 – TEST PLANS
Description: This ‘Key ’ evaluates the process used to develop and implement test plans for testing and approving products that meet customer requirements. It includes how test plans are continuously improved with new requirements such that results achieved from approved product lead to better products.
Lead Assessor Questions:
1.
How are test plans for new features / products developed? Who has input to their creation? 2.
Please describe how DFMEA ’s provide directional content to the creation of your test plans. 3.
Is there a standardized template used for test plan development? 4.
When in the development cycle are test plans created and how are they linked to the customer specifications? 5.
Are new tests developed when new specifications are created? 0 pts
Auditee has no formal test plans - they do minimal testing Auditee does not create their own test plans (customer assumes this responsibility) 1 pt Evidence shows only standard tests are used and minimal or no critical thought is given for new
tests.
Tests plans are typically created close to product launch (reacting to the timetable)
The Product Approval Group & Design Engineering only occasionally interact in test plan
development
There is evidence that DFMEA ’s are used in some test plan creation.
2 pts Test plans are based on prior test documents; no specific regional /global template is used
New, unique tests are developed for unique features or new product based upon customer
insights
Some test plans are developed early in the process.
Test plans are jointly developed between the Product Approval Group and Design Engineering
Group with the Product Approval Group having the overall authority on most test plan content.
There is some test plan coordination / interaction with customers (i.e. effect on other customer
parts).
There is evidence that DFMEA ’s are used in most test plan creation.
3 pts
Test plan development template (w/standard tests) used to drive critical thought for all project
test plans.
There is clear evidence of new tests proactively developed and based upon customer insights.
These tests are shown to be linked to newly developed product specifications
Test plans are jointly developed with the Product Approval Group and Design Engineering, and
it is clearly documented that the Product Approval engineer has the final authority on all test plan content.
There is considerable test plan coordination / interaction with customers (i.e. effect on other
customer parts).
There is evidence that DFMEA ’s are used in all test plan creation.
Most test plans are developed early in the process.。