Process Flowchart Employee - Excel

Document Sample
Process Flowchart Employee - Excel Powered By Docstoc
					                                                                                         Audit No./Year:
                                                  AS 2 Process Audit
                                                  - Summary Report -                          Audit Date:


   Total no. of employees:                                       Employees in quality dept.:
   Main customer(s):
   Audit reason:   Regular audit:
                   Initial audit for new supplier:
                   Initial audit for new process:
                   Audit due to quality incident:
                   Audit due to process change (e.g. relocation):


   Audit Summary:
                                                                                        This audit            Previous audit
                   Number of Major Deviations:                                                   0
                   Number of Minor Deviations:                                                   0
                   Number of Improvement Potentials:                                             0
                   Percentage of answered questions:                                       100.00%
                   Latest correction date:

   Process released ?            yes             no       (see comments below)


   Best Practice

   Date, Process Manager signature                                                Date, Auditor signature

QA-ANG                                 a46b4d56-9534-498a-80df-ea506dd2d977.xls                             Page 1 of 10
                                                                       AS 2 Process Audit                                                       Audit No./Year: 0

                                                                        - Questionnaire -                                                            Audit Date: 0

                                                                                                                                                       Process: 0
  Dev.      Quest.                                                                                                                         Audited     Rating
                     Area               Item                                                                                                                         Findings / Remarks
  No.        No.                                                                                                                           yes no Ma Mi Ip C

            1. Voice of the customer
                                        Are all process related legal and customer requirements / specifications available (current
                     Customer           versions) ?
                     Specifications /   Are they distributed / updated timely to the process responsible ?
         1.1                                                                                                                               X                    X
                     Legal              Are they met (including AS5) ? If not, is corrective action planned ?
                     Requirements       Are customer inquiries on new products / engineering changes handled through a crossfunctional
                                        team? Are they appropriate to manufacturing needs?

                     Customer           Is there a regular contact between customer and manufacturing ?
                     Feedback (on       Is the actual quality performance evaluated by the customer? Is this known by the operational level
         1.2         Product &          (workers, team leader,...)?                                                                         X                   X
                     Delivery           Is the customer evaluation result subject to corrective action (or, if satisfying, to continuous
                     Performance)       improvement) ?

                     For Supplier     Who is responsible for APQP (Department)
         1.3         processes only : Is there a functioning APQP process in place ?                                                       X                    X
                     APQP             Is the process executed by a cross functional team ?

            2. Production Part Approval Process (PPAP) / Process Release
                                        Does a process flowchart, process layout and P-FMEA exist ?
                                        Are they up to date and consistent ?
                                        Has the process been systematically developed (e.g. acc. to QS9000 FMEA Manual, VDA 4 Part 2
         2.1         Process FMEA       Step 2 or similar) by a cross functional team ?                                              X                          X
                                        Are risk criteria (ie: RPN) to take actions determined and known ?
                                        Have actions against identified critical concerns been taken?
                                        Is the same rating on severity used for PFMEA and DFMEA?

                                        Does a complete Control Plan exist and is it up to date?
                                        Does the Control Plan contain all process related critical characteristics (SC/CC) ?
                                        How are the results of the SC/CC supervision?
         2.2         Control Plan       Are the SC/CC characteristics reflected from the PFMEA?                                            X                    X
                                        Is the Control Plan a controlled document ?
                                        Does the Control Plan specify all inspection items, responsibilities, methods, frequencies and
                                        reaction plans from incoming inspection to delivery ?

QA-ANG                                                                                          a46b4d56-9534-498a-80df-ea506dd2d977.xls                                                  Page 2 of 10
                                                                        AS 2 Process Audit                                                           Audit No./Year: 0

                                                                         - Questionnaire -                                                                Audit Date: 0

                                                                                                                                                            Process: 0
  Dev.      Quest.                                                                                                                              Audited     Rating
                     Area              Item                                                                                                                               Findings / Remarks
  No.        No.                                                                                                                                yes no Ma Mi Ip C

                                       Are all delivered products approved by the customer (see PPAP warrants) ?
                                       Is there a system ensuring PPAP / interim approval prior to SOP ?
                                       Have quality targets and/or SPC requirements been clearly defined with the customer (see frame
         2.3         PPAP              contract) and are they subject to continuous improvement ?                                               X                    X
                                       Are all PPAPs to customers on time / approved first time ?
                                       Are interim product releases documented and handled systematically, where PPAP could be
                                       completed in time ?

                                       Have Run@Rate tests been performed and documented ?
                                       Did Run@rate tests include all serial stations / tools as they will be used in serial production ? Are
                                       test conditions documented and reproducible ?
                                       Did these Run@Rates achieve the quoted capacities and quality requirements ?
         2.4         Run@Rate                                                                                                                   X                    X
                                       If not, is there an action plan in place ?
                                       Is an early containment procedure applied where necessary (analog to General Motors GP12
                                       procedure or similar) ?
                                       Does the process comply with AS5 (Are forbidden or restricted materials used ?)

                                       Are all gages used as described in the control plan ?
                                       Have Gage R&R studies acc. to AIAG MSA (QS9000) been performed ?
                     Measurement &
                                       Is process to document and retain these results ?
         2.5         Inspection                                                                                                                 X                    X
                                       Is gage handling fail safe (mistake proofed) to the actual users ?
                                       Are all gages, including employee owned gages, registered centrally for timely requalification ?
                                       Are master rejects and boundary samples included in calibration system?

                                       Are all SC/CC controlled variable characteristics capable (Ppk > 1,67, Cpk > 1,33 and correctly
                     Initial process   calculated) ?
         2.6                                                                                                                                    X                    X
                     capability        Are responsible employees appropriately skilled ?
                                       Is appropriate action taken, when Ppk is below 1,67 resp. Cpk below 1,33

QA-ANG                                                                                           a46b4d56-9534-498a-80df-ea506dd2d977.xls                                                      Page 3 of 10
                                                                   AS 2 Process Audit                                                        Audit No./Year: 0

                                                                    - Questionnaire -                                                             Audit Date: 0

                                                                                                                                                    Process: 0
  Dev.      Quest.                                                                                                                      Audited     Rating
                     Area           Item                                                                                                                          Findings / Remarks
  No.        No.                                                                                                                        yes no Ma Mi Ip C

            3. Manufacturing Process
                                    Are incoming goods inspected systematically acc. to their specification and acc. to the control plan
                                    Are specifications agreed by the process owner / supplier (see contracts) ?
                                    Are inspection instructions and results properly documented ?
                                    Is inspection personnel appropriately skilled ?
                                    Is corrective action required of (sub-)suppliers for non-conformances ?
         3.1                        Are goods easy to locate, identifiable and traceable in the incoming area ?                          X                   X
                                    Are approved parts clearly identified prior to being put into inventory ?
                                    If incoming inspection is waived, is there evidence for sufficient (sub-)suppliers component quality
                                    assurance ?
                                    Are different engineering levels (e.g. index A / B) of parts clearly segregated in production and
                                    warehouse ?
                                    Does the supplier component approval include an AS5 conformity declaration or similar ?

                                    Has the manufacturing process been systematically analyzed for critical subprocesses (e.g.
                                    welding, riveting, heat treatment) ?
                     Process        Are critical process parameters monitored and controlled ?
                     Parameters /   Are these parameters part of the control plan ?
         3.2                                                                                                                            X                    X
                     Special        Is the testing adequate to the process / product?
                     Processes      Is unauthorized modification of process parameters prohibited ? How ?
                                    Are new manufacturing techniques sufficiently tested prior to release in serial production ?
                                    Are backup processes prepared to avoid production breakdown ?

                                    Do work, inspection and packaging instructions exist and do they clearly describe process
                                    operations to employees?
                                    Are the instructions in accordance with the process ?
                                    Are the workers able to read and understand the instructions (language problem)?
                     Product and
                                    Do they include handling of hazardous materials, if applicable ?
         3.3         Process                                                                                                            X                    X
                                    Do instructions refer to corrective action measures in case of non-conformances ?
                                    Are the instructions controlled documents ? Are the instructions the same for all shifts ?
                                    Do controlled part and assembly drawings exist ? Do the instructions / drawings identify SC/CC´s
                                    (AS 52) ?
                                    Do Safety Data Sheets (SDS) for used chemicals exist and are they known to related personnel ?

QA-ANG                                                                                      a46b4d56-9534-498a-80df-ea506dd2d977.xls                                                   Page 4 of 10
                                                                       AS 2 Process Audit                                                        Audit No./Year: 0

                                                                        - Questionnaire -                                                             Audit Date: 0

                                                                                                                                                        Process: 0
  Dev.      Quest.                                                                                                                          Audited     Rating
                     Area              Item                                                                                                                           Findings / Remarks
  No.        No.                                                                                                                            yes no Ma Mi Ip C

                                     Are process control charts maintained and analyzed ?
                                     Are process records (ie: control charts) correctly designed (i.e.: regarding control limits) and
         3.4         Process Control                                                                                                        X                    X
                                     known and understood to the responsible personnel ?
                                     Do process records indicate deviations from the specification clearly ?

                                       Are all personnel (all shifts and temporary employees)– manufacturing, maintenance and support,
                                        trained and instructed properly (esp. on automotive industry quality requirements) ?
                                       Are training procedures in place and documented?
         3.5         Manpower                                                                                                               X                    X
                                       Are training needs defined for each job description?
                                       Is training effectiveness measured and documented?
                                       Are instruments for employee motivation used and effective ?

                                       Is the needed production and test equipment available and fit for use (including safety, health &
                                       environmental requirements) ?
                     Process           Is the calibration status indicated on measurement devices ?
         3.6                                                                                                                                X                    X
                     Equipment         Are customer owned tools and equipment clearly identifiable (tagged) and handled acc. to
                                       customer requirements ?
                                       Is unreleased equipment identified and appropriately stored to avoid unauthorized use ?
                                       Are first produced parts after shift start-up, order changes or maintenance activities specially
                     Production Start- inspected to detect systematic errors (e.g. incorrect parts used, wrong parameter setup, operator
                     Up - First piece error...) ?
         3.7                                                                                                                                X                    X
                     sample            Are master rejects utilized prior to production start up ?
                     inspection        Are these inspections / tests clearly defined in work instructions ?
                                       Are first piece inspections documented and maintained ?
                                       Is mistake-proofing (Poka Yoke) in place, functioning and controlled ?
                                       Can existing Poka-Yoke devices be bypassed or switched off ?
         3.8         Mistake -proofing                                                                                                      X                    X
                                       Are all mistake proofing devices validated regularly (wear and tear) ?
                                       Is a mix up of material avoided ?

QA-ANG                                                                                           a46b4d56-9534-498a-80df-ea506dd2d977.xls                                                  Page 5 of 10
                                                                       AS 2 Process Audit                                                           Audit No./Year: 0

                                                                        - Questionnaire -                                                                Audit Date: 0

                                                                                                                                                           Process: 0
  Dev.      Quest.                                                                                                                             Audited     Rating
                     Area              Item                                                                                                                              Findings / Remarks
  No.        No.                                                                                                                               yes no Ma Mi Ip C
                                       Is the process equipment part of the preventive maintenance system?
                                       Does the system include monitoring and optimization of maintenance activity frequencies,
                                       perishable tooling and machine downtime ?
                                       Are planned and unplanned maintenance activities documented ?
                                       Is needed maintenance equipment available ?
                     Maintenance /
                                       Is equipment systematically requalified after maintenance / breakdowns (capability and/or R&R
         3.9                           studies) ?                                                                                              X                    X
                                       Are malfunctioning automated processes temporarily replaced by manual operation ?
                                       Are these operations handled acc. to the process standards for manual processes (regarding
                                       documentation, training, inspection) ?
                                       Are these instances documented and tied to lot traceability records ?
                                       Is part related equipment marked with part-No. / engineering level and is it part of the modification
                                       Are process related part or raw material stock levels (esp. at the manufacturing area), packaging
                                       and lot sizes adjusted to production needs (e.g. one piece flow)?
                                       Does the product handling and storage prevent damage or deterioration?
         3.10                          Are similar parts (e.g. different CS sensor types) clearly identifiable and segregated to avoid mix     X                    X
                                       up ?
                                       Are goods locatable, identifiable and traceable in the incoming area and warehouses ?
                                       Are material and goods handled according to fi/fo?
                     Production        Have deliveries to customers been 100% in time ?
         3.11                                                                                                                                  X                    X
                     scheduling        If not, is there an actionplan in place and are the actions appropriate?

                                      Is non-conforming material clearly identified and segregated from conforming material ? Is the
                                      segregated area identified ?
                     Handling of Non- Is timely and proper disposition of non-conforming material ensured ?
         3.12        Conforming       Is all potentially non-conforming material identified and treated similarly ?                            X                    X
                     Material         Is all reworked product reinspected acc. to the standard / rework process requirements ?
                                      Is reworked material / parts tight to the traceability system?
                                      Is waste material and / or rework quantified and systematically minimized ?

                                       Is process data recorded and statistically analyzed, where useful ?
                                       Are all process records handled in acc. to related record retention procedures (for suppliers: AS1)
         3.13                          ?                                                                                                       X                    X
                                       Can retained documents be retrieved according to AS4 ?
                                       Are record retention procedures documented and followed?

QA-ANG                                                                                           a46b4d56-9534-498a-80df-ea506dd2d977.xls                                                     Page 6 of 10
                                                                       AS 2 Process Audit                                                       Audit No./Year: 0

                                                                        - Questionnaire -                                                            Audit Date: 0

                                                                                                                                                       Process: 0
  Dev.      Quest.                                                                                                                         Audited     Rating
                     Area               Item                                                                                                                         Findings / Remarks
  No.        No.                                                                                                                           yes no Ma Mi Ip C

                                      Are components and products identifiable and traceable from incoming to delivery ?
                                      Is suspect or reworked material clearly identified and tied to traceability information ?
         3.14                         Are identification of inspection and test status for products maintained at each stage of production? X                   X
                     and Traceability
                                      Suppliers only :
                                      Do manufacturing lot sizes meet Autoliv requirements?

                                        Is all finished product systematically inspected and released before shipment to the customer ?
                                        Is the responsibility to approve products for shipment clearly defined?
                     Final Inspection   Is it assured that only approved parts can be send to the customer?
         3.15                                                                                                                              X                    X
                     / Shipping         Is the inspection based on customer product specifications ?
                                        Are dock audits performed ?
                                        Is all finished product packaged acc. to customer specifications (i.e.: weight) ?

                                        Is it analyzed if there are legal / internal requirements which need to be fulfilled for working
                                        conditions and / or housekeeping (on safety, health and environment, enough light for visual
                     Working            checks, noise inspection in quiet areas) ?
         3.16        Conditions /       Are all working areas kept in a way that the specified product quality and quantity can be produced X                   X
                     Housekeeping       continually ?
                                        Are working conditions and housekeeping subject to continuous improvement (e.g. Kaizen
                                        workshops, 5S programs) ?
                     For Supplier       Are processes and products internally audited regularly ?
                     processes only:    Is audit frequency adjusted to production volume and process stability ?
         3.17                                                                                                                              X                    X
                     Internal audits    Are auditors qualified and experienced ?
                                        Are audit findings regularly reviewed and corrected in time ?

QA-ANG                                                                                          a46b4d56-9534-498a-80df-ea506dd2d977.xls                                                  Page 7 of 10
                                                                       AS 2 Process Audit                                                           Audit No./Year: 0

                                                                        - Questionnaire -                                                                Audit Date: 0

                                                                                                                                                             Process: 0
  Dev.      Quest.                                                                                                                             Audited       Rating
                     Area                Item                                                                                                                                              Findings / Remarks
  No.        No.                                                                                                                               yes no Ma Mi Ip C

            4. Improvement
                                     Are product / process failures systematically analyzed (e.g. internal ppm) and corrected with
                                     involvement from a cross functional team ?
                                     In case of a failure, are all affected parts traceable (including parts which are currently quarantined
                     Failure         for other reasons ?)
         4.1         Management /    Are common problem solving methods (e.g. 7 Tools, TOPS 8D) efficiently used ?                             X                      X
                     Problem Solving Are FMEA and control plan updated as a result of the root cause analysis?
                                     Are permanent corrective actions implemented across similar processes throughout the plant?
                                     Is corrective action effectiveness monitored ?
                                     Are customer and line rejects analyzed regular? Are there actions diverted from?

                                         Is a comprehensive continuous improvement philosophy deployed throughout the organization
                                         including management support?
                     Continuous          Are “lessons learned” systematically documented and is this information used by the process
         4.2                                                                                                                                   X                      X
                     Improvement         responsible, also on similar and new processes for continuous improvement ?
                                         Are process targets defined and are they regularly reviewed and refined ?
                                         Are tools to monitor the PDCA process in use (e.g. QOS...)

                                                                                                                                               28   0    0    0   0   28   No of ratings

                                                                                                                                                         H    N   V   C
             Total number of questions   28
        Number of questions answered     28
     Percentage of answered questions    100.00%
           Number of Major Deviations    0
           Number of Minor Deviations    0
     Number of Improvement Potentials    0
          Total Number of Open Issues    0

QA-ANG                                                                                           a46b4d56-9534-498a-80df-ea506dd2d977.xls                                                                       Page 8 of 10
                                                                                                                                    Audit No. / Year:        0
                                                                          AS 2
                                                           Process Audit Finding Report - AFR -                                          Audit date:         0

                                                                                                                                           Process:          0

   Dev.                              Audit                                                                                                              Correction

                                    Question   Finding / Improvement potential                                  Corrective action   Responsible           Date
    No.                               No.                                                                                                               (YYYY-MM-DD)











QA-ANG                                                                     a46b4d56-9534-498a-80df-ea506dd2d977.xls                                       Page 9 of 10
                                                                                                                                    Audit No. / Year:        0
                                                                          AS 2
                                                           Process Audit Finding Report - AFR -                                          Audit date:         0

                                                                                                                                           Process:          0

   Dev.                              Audit                                                                                                              Correction

                                    Question   Finding / Improvement potential                                  Corrective action   Responsible           Date
    No.                               No.                                                                                                               (YYYY-MM-DD)











QA-ANG                                                                     a46b4d56-9534-498a-80df-ea506dd2d977.xls                                      Page 10 of 10

Description: Process Flowchart Employee document sample