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ObjectivObjective1. The study was to develop a health supervision scale of health products manufacturers.2. Use the scale and inspect its reliability and validity.3. Determine the enterprise-class and monitoring frequencyMethodsUsing hazard analysis critical control pints (HACCP),we did hazard analysis (HA) duringthe whole production process, and ascertain critical control point(CCP).Collect target relateditems through literature and consultation with specialists, and sieve the items with help of staticsmethods such as out rate, mean and variation coefficient method by which out rate and thespecialists marked scores graded by 5 was sifted through their judge for the reliability,importance and feasibility of items. The items left were estimated weighted weight by rank sumratio (RSR) and analytic hierarchy process (AHP). Arrange preview investigation taking test ofthe test-retest reliability, internal consistence, scorer reliability, content validity, structure validityand criterion validity.Results1. Initial scale was made up of 8 dimensions, and was divided into 4 key projects and 57ordinary items. After the specialist advice, As to k＞20%,M＞3，CV＜0.2，removing an index ofsecondary indicators and 6 index of thirdary indicators.Combining 4 index of thirdary indicatorswith experts’advice.The scale were sifted into 4 key projects and 46 ordinary items. The finalweights of the three indicators are 0.0105-0.0498. The value of scale was ranged from 1 point-10 points through equivalent transformation.2. The basic situation of experts: Experts were mainly from eight municipal health bureaus, aprovincial health inspection agencie and nine municipal health inspection agencies. Thirtyexperts participated in the project advisory. The youngest man was 36 years old. Maximum was57 years old,and average age was 46.5士7.3.The minimum work experience was 13 years.Thelongest was 35 years,and average work experience is 25.6士6.8. Six men were Masters.Twentypeople were undergraduate.Four people were college.Forty people were senior titles,and sixtypeople were associate professors.3. The reliability of expert: The response rate was 100%.Cr was 0.76.Coordination factors weregreater than 0.3. P<0.05 4. Determine the monitoring frequency.①Standard score was more than 90, as excellent, A level,monitoring frequency was more than 1 times / two year.②Standard score was between 70 and89, as good, B level, monitoring frequency was more than 1 times / year.③Standard score wasbetween 60 and 69, as medium, C level, monitoring frequency was more than 2 times / year.④Standard score was less than 60, no rating.5. Arrange preview investigation according of the test of reliability and validity. Test-retestreliability of whole was 0.918 (P＜0.05)，and test-retest reliability of each branch were 0.869 ,0.762, 0.716, 0.786,0.862,0.732,0658,0.736，(P＜0.05). Internal consistence of whole was0.7825, and internal consistence of each branch were 0.872,0.863,0.805,0.834,0.825,0.801,0.816,0.658.Scorer reliability of whole was 0.765 (P＜0.05), and scorer reliability of each branch were0.763,0628,0.593,0.624,0.706,0.619,0.582,0.621, (P＜0.05).Structure validity was testedthrough confirmatory factor analysis, NFI,NNFI,CFI, FI were more than 0.9.The Spearmancorrelation coefficients between scale score of whole and the Experimental results were 0.742(P＜0.05).6. Test the quality of products : microbial contamination was found in 19 kinds of products. Theantibacterial rate of a product was unqualified. The stability of 2 kinds of products wasunqualified.ConclusioConclusionAccording to HACCP, we developed a health supervision scale of health productsmanufacturers. Arrange preview investigation taking test of the test-retest reliability, internalconsistence, scorer reliability, content validity, structure validity and criterion validity. Theresults shew that the scale had good reliability and validity.The scale could be applied in healthsupervision of health products manufacturers.
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