Imeko TC14 2013 18
Imeko TC14 2013 18
Imeko TC14 2013 18
applications it is suggested to use a (heuristic) rule of thumb on PFMEA). Moreover, each measurement system
- the higher is the risk, the more rigorous MSA requirements referenced in PFMEA as failure or cause detection, is
should be (similar to FMEA approach). precisely associated with corresponding process step and
Table 3. shows an example of SRM filled with specific controlled characteristics. Therefore, replacing SRM in the
MSA requirements for MSA planning (for the purpose of first proposed solution by risk matrix built on Severity and
clarity, content of the cells has been detailed in Table 4). Occurrence indices, it is possible to plan MSA taking
additional advantage of developed PFMEA. Moreover, one
Table 4: Requirements for MSA planning – specification. can consider updates of MSA plan as PFMEA is
Specification periodically reviewed and updated, reflecting process
MSA planning improvement. Thus, MSA plan changes can follow process
Stability -
requirements Capability improvements.
Control Chart
Very often, Xbar-R; n=5, Linearity study (n=5); Obviously, there is no need to make MSA specification
very sampling every GR&R- ARM method: different for each of 100 cells of the above mentioned risk
rigorously 4 hours (3 times 10 parts x 3 trials / operator, matrix (Severity x Occurrence). Instead, rather few (but
/ shift) GR&R ≤ 10%; monthly precisely bordered) risk areas can be defined, as it is
Often, Xbar-R; n=3, Bias study; GR&R-ARM recommended in process optimization based of PFMEA [6].
rigorously sampling daily; method: 10 parts x 3 trials An Example is shown in Fig. 1.
per op., %GR&R ≤ 10%;
every 3 months O 10
Moderate X-mR; Bias study; C 9
frequency, sampling GR&R-ARM method: C 8 Rigorous & frequent
rigorously weekly; 5 parts x 3 trials / operator, U 7 MSA
%GR&R ≤ 10%; R 6
every 6 months R 5
Often, X-mR; GR &R- RM or ARM E 4 Moderately freq.
simplified sampling daily; method: 5 parts x 3 trials N 3 & rigorous MSA
per op., %GR&R ≤ 20%; C 2
every 3 months Simplified & rare MSA
E 1
Rarely, None GR&R- RM or ARM 1 2 3 4 5 6 7 8 9 10
simplified method: 5 parts x 2 trials S E V E R I T Y
per op., %GR&R ≤ 20%;
every 12 months Fig. 1: MSA planning guidelines based on PFMEA risk
None Capability and short term stability assessed areas recommended for process improvement [6].
only at the PPAP phase.
Another possible way of taking advantage of PFMEA for
While risk description in SRM (Table 3) has to fit MSA planning is by process risk ranking. Sorting failures
company risk perception or risk management strategy, MSA with their causes by Severity (Sev), Occurrence (Occ) and
specification has to be adjusted to available resources Detection (Det) one automatically obtains a ranking of
capable of setting up and running control charts and process detection controls, i.e. the ranking of measurements
conducting measurement system capability studies (Table 4). systems addressing characteristics with the highest effect
Attempts of such adjustments performed by author showed risk for external and internal customers (Sev), with the
deficiencies of resources for MSA in companies trying to highest probability of a cause (Occ), sorted at the and by
optimize MSA planning. There are two alternatives in such risk of not detecting a non-conformance (Det). Such a risk
a case: analysis approach has been recently recommended [6, 7, 8]
1. acquire necessary resources (proactive approach, as opposed to criticized traditional RPN (Risk Priority
recommended), Number) strategy, in which risk had been measured as
2. adjust MSA planning specification to available resources, multiplication of all risk indices, giving misleading
reducing frequencies and, if necessary, methods, in a recommendations for process improvement. Similar effect is
proportional manner to retain dependence between MSA obtained if RPN is replaced by SOD index, which is a
plan and risk identified in SRM - Tables 1,2,3 (reactive product of combining Sev, Occ and Det digits [5]. Example
approach). of sorting effect is shown in Table 5.
The latter can be achieved e.g. by iterative process of Please note, that the same inspection method (see Table
reducing the plan and summing up number of MSA studies 5 – methods X and E) can be mentioned in PFMEA more
and number of control charts samples to collect during a than once (typically: final inspection).
predefined period of time (e.g. one year) and comparing it Each detection method referred in PFMEA is connected
with company actual capabilities (depending on resources with relevant measurement system (specified in more detail
devoted for MSA), until both match each other. in Control Plan), Thus, according to the process risk ranking,
measurement system ranking can be developed. being a
5. MSA PLANNING BASED ON PFMEA basis for MSA planning. The higher is a measurement
system position in the ranking, the stricter MSA
Assuming that a company has PFMEA in place, one requirements should apply, both in terms of rigor and
finds in PFMEA all measurement systems referenced in frequency. Evidently, defining separate MSA requirements
control plans (according to [2] control plan should be based for each ranking position is not reasonable. Instead, rational
11th International Symposium on Measurement and Quality Control 2013, September 11-13, 2013, Cracow-Kielce, Poland
Detection - Cause
Detection - Failure
need to be further included in proposed methods in further
developments:
Failure Effects
Failure Cause
Failure Mode
Occurrence
1. A few identical or similar gauges are assigned to the
Operation
Detection
same measurement task (characteristics).
Severity
SOD
ting a probability of measurement system falling into of
out of control state: a gauge robustness and frequency of
Developed PFMEA for operations O1, O2, O3
measurements (e.g. 100% inspection vs sampling).
O1 A B 7 C 4 D E 5 745 3. Differences in time of measurement cycle affects time of
O1 A B 7 F 2 G E 4 724 MSA test, which could affect MSA planning in terms of
O2 H I 4 J 7 K X 9 479 a test specification (see – Table 4.) and resources.
O2 M N 9 P 3 Q X 6 936 4. Apart from measurement systems for variable data, there
O2 M N 9 Q 5 R X 3 953 can also be measurement systems for attribute data in
O3 T U 9 V 4 W X 2 942 place (e.g. go-nogo gauges, visual inspection) with other
PFMEA after SOD sorting MSA methods (Cross Tab – Cohen Kappa, Signal
O2 M N 9 Q 5 R X 3 953 Detection, Analytic [1]) to include in MSA plan.
O3 T U 9 V 4 W X 2 942 Despite the above considerations, the proposed methods
O2 M N 9 P 3 Q X 6 936 – heuristic and simple, matching widely used quality tools in
O1 A B 7 C 4 D E 5 745 industry, with no special qualifications necessary from
O1 A B 7 F 2 G E 4 724 quality engineers and requiring no extra experimental data –
O2 H I 4 J 7 K X 9 479 would radically increase benefits from MSA by rational
planning.
Table 6: Risk ranking as a result of PFMEA.
No. Measurement REFERENCES
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4 D, E (O1) (SCC weekly, GR&R quarterly
Particular requirements for the application of ISO 9001:2008
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Moderate (GR&R yearly)
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